Molecule & product database

Drugs & APIs

Market United States (US)

GenericRadar data is informational only. Verify patent, regulatory and launch decisions against current official sources.

Generic / Product	NDA / BLA	Dosage form / Route	Current GNR status	Patents in United States
NITROUS OXIDE NITROUS OXIDE, USP	221892 Product 221892/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE TRIUMEQ	205551 Product 205551/001	TABLET · ORAL EQ 600MG BASE;EQ 50MG BASE;300MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	2
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE TRIUMEQ PD	215413 Product 215413/001	TABLET, FOR SUSPENSION · ORAL EQ 60MG BASE;EQ 5MG BASE;30MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	2
ABACAVIR SULFATE; LAMIVUDINE ABACAVIR SULFATE AND LAMIVUDINE	204311 Product 204311/001	TABLET, FOR SUSPENSION · ORAL EQ 60MG BASE;30MG FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	2
ABALOPARATIDE TYMLOS	208743 Product 208743/001	SOLUTION · SUBCUTANEOUS 3.12MG/1.56ML (2MG/ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL_CHECKING	9
ABAMETAPIR XEGLYZE	206966 Product 206966/001	LOTION · TOPICAL 0.74% FDA marketing: Discontinued	NEVER_MARKETED FINAL	2
ABEMACICLIB VERZENIO	208716 Product 208716/001	TABLET · ORAL 50MG FDA marketing: Prescription	Master only	1
ABEMACICLIB VERZENIO	208716 Product 208716/002	TABLET · ORAL 100MG FDA marketing: Prescription	Master only	1
ABEMACICLIB VERZENIO	208716 Product 208716/003	TABLET · ORAL 150MG FDA marketing: Prescription	Master only	1
ABEMACICLIB VERZENIO	208716 Product 208716/004	TABLET · ORAL 200MG FDA marketing: Prescription	Master only	1
ABIRATERONE ACETATE YONSA	210308 Product 210308/001	TABLET · ORAL 125MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	2
ABIRATERONE ACETATE ZYTIGA	202379 Product 202379/001	TABLET · ORAL 250MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
ABIRATERONE ACETATE ZYTIGA	202379 Product 202379/002	TABLET · ORAL 500MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	0
ABIRATERONE ACETATE; NIRAPARIB TOSYLATE AKEEGA	216793 Product 216793/001	TABLET · ORAL 500MG;EQ 50MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	14
ABIRATERONE ACETATE; NIRAPARIB TOSYLATE AKEEGA	216793 Product 216793/002	TABLET · ORAL 500MG;EQ 100MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	14
ABROCITINIB CIBINQO	213871 Product 213871/001	TABLET · ORAL 50MG FDA marketing: Prescription	2036 CANDIDATE FINAL	3
ABROCITINIB CIBINQO	213871 Product 213871/002	TABLET · ORAL 100MG FDA marketing: Prescription	2036 CANDIDATE FINAL	3
ABROCITINIB CIBINQO	213871 Product 213871/003	TABLET · ORAL 200MG FDA marketing: Prescription	2036 CANDIDATE FINAL	3
ACALABRUTINIB CALQUENCE	210259 Product 210259/001	CAPSULE · ORAL 100MG FDA marketing: RX	2035 DEEP_REVIEW FINAL	9
ACALABRUTINIB MALEATE CALQUENCE	216387 Product 216387/001	TABLET · ORAL EQ 100MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	8
ACECLIDINE HYDROCHLORIDE VIZZ	218585 Product 218585/001	SOLUTION/DROPS · OPHTHALMIC EQ 1.44% BASE FDA marketing: Prescription	2044 CANDIDATE FINAL_CHECKING	7
ACETAMINOPHEN ACETAMINOPHEN	204767 Product 204767/001	SOLUTION · INTRAVENOUS 1GM/100ML (10MG/ML) FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	1
ACETAMINOPHEN ACETAMINOPHEN	204957 Product 204957/001	SOLUTION · INTRAVENOUS 500MG/50ML (10MG/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
ACETAMINOPHEN ACETAMINOPHEN	204957 Product 204957/002	SOLUTION · INTRAVENOUS 1GM/100ML (10MG/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
ACETAMINOPHEN ACETAMINOPHEN	206610 Product 206610/001	POWDER · INTRAVENOUS 1GM/VIAL FDA marketing: Discontinued	2021 DISQUALIFIED FINAL	0
ACETAMINOPHEN ACETAMINOPHEN	206968 Product 206968/001	SOLUTION · INTRAVENOUS 1GM/100ML (10MG/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
ACETAMINOPHEN OFIRMEV	022450 Product 022450/001	SOLUTION · INTRAVENOUS 1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2022 DISCONTINUED FINAL	4
ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE APADAZ	208653 Product 208653/001	TABLET · ORAL 325MG;EQ 6.12MG BASE FDA marketing: DISCONTINUED	2023 DISQUALIFIED FINAL	5
ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE APADAZ	208653 Product 208653/002	TABLET · ORAL 325MG;EQ 4.08MG BASE FDA marketing: DISCONTINUED	2023 DISQUALIFIED FINAL	5
ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE APADAZ	208653 Product 208653/003	TABLET · ORAL 325MG;EQ 8.16MG BASE FDA marketing: DISCONTINUED	2023 DISQUALIFIED FINAL	5
ACETAMINOPHEN; IBUPROFEN ADVIL DUAL ACTION WITH ACETAMINOPHEN	211733 Product 211733/001	TABLET · ORAL 250MG;125MG FDA marketing: Over-the-counter	2020 EXCLUDED FINAL	1
ACETAMINOPHEN; IBUPROFEN COMBOGESIC	209471 Product 209471/001	TABLET · ORAL 325MG;97.5MG FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	2
ACETAMINOPHEN; IBUPROFEN SODIUM COMBOGESIC IV	215320 Product 215320/001	SOLUTION · INTRAVENOUS 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL_CHECKING	6
ACETAMINOPHEN; NAPROXEN SODIUM TYLENOL WITH NAPROXEN	219962 Product 219962/001	TABLET · ORAL 325MG;110MG FDA marketing: Over-the-counter	2026 EXCLUDED FINAL	0
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE XARTEMIS XR	204031 Product 204031/001	TABLET, EXTENDED RELEASE · ORAL 325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2017 DISCONTINUED FINAL	12
ACETYLCYSTEINE CETYLEV	207916 Product 207916/001	TABLET, EFFERVESCENT · ORAL 500MG FDA marketing: Discontinued	2019 DISCONTINUED FINAL	3
ACETYLCYSTEINE CETYLEV	207916 Product 207916/002	TABLET, EFFERVESCENT · ORAL 2.5GM FDA marketing: Discontinued	2019 DISCONTINUED FINAL	3
ACETYLCYSTEINE LYSINE LEGUBETI	215040 Product 215040/001	FOR SOLUTION · ORAL EQ 500MG BASE/PACKET FDA marketing: DISCONTINUED	2024 DISCONTINUED FINAL	0
ACETYLCYSTEINE LYSINE LEGUBETI	215040 Product 215040/002	FOR SOLUTION · ORAL EQ 2.5GM BASE/PACKET FDA marketing: DISCONTINUED	2024 DISCONTINUED FINAL	0
ACLIDINIUM BROMIDE TUDORZA PRESSAIR	202450 Product 202450/001	POWDER, METERED · INHALATION 0.4MG/INH FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	2
ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE DUAKLIR PRESSAIR	210595 Product 210595/001	POWDER, METERED · INHALATION 0.4MG/INH;0.012MG/INH FDA marketing: Discontinued	2026 DISCONTINUED FINAL	2
ACOLTREMON TRYPTYR	217370 Product 217370/001	SOLUTION/DROPS · OPHTHALMIC 0.003% FDA marketing: Prescription	2031 DEEP_REVIEW FINAL_CHECKING	5
ACORAMIDIS HYDROCHLORIDE ATTRUBY	216540 Product 216540/001	TABLET · ORAL EQ 356MG BASE FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	13
ACYCLOVIR AVACLYR	202408 Product 202408/001	OINTMENT · OPHTHALMIC 3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2019 EXCLUDED FINAL	0
ACYCLOVIR SITAVIG	203791 Product 203791/001	TABLET · BUCCAL 50MG FDA marketing: Discontinued	2025 DISCONTINUED FINAL	3
ADAGRASIB KRAZATI	216340 Product 216340/001	TABLET · ORAL 200MG FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	5
adalimumab Humira	125057 Product 125057/001	Injection · Subcutaneous 40MG/0.8ML Autoinjector FDA marketing: Rx	2016 DEEP_REVIEW FINAL	66
adalimumab Humira	125057 Product 125057/002	Injection · Subcutaneous 40MG/0.8ML Pre-Filled Syringe FDA marketing: Rx	2016 DEEP_REVIEW FINAL	66
adalimumab Humira	125057 Product 125057/003	Injection · Subcutaneous 20MG/0.4ML Pre-Filled Syringe FDA marketing: Disc*	2021 DISCONTINUED FINAL	66
adalimumab Humira	125057 Product 125057/004	Injection · Subcutaneous 40MG/0.8ML Single-Dose Vial FDA marketing: Disc*	2015 DISCONTINUED FINAL	66
adalimumab Humira	125057 Product 125057/005	Injection · Subcutaneous 10MG/0.2ML Pre-Filled Syringe FDA marketing: Disc*	2021 DISCONTINUED FINAL	66
adalimumab Humira	125057 Product 125057/006	Injection · Subcutaneous 40MG/0.4ML Pre-Filled Syringe FDA marketing: Rx	2016 DEEP_REVIEW FINAL	66
adalimumab Humira	125057 Product 125057/007	Injection · Subcutaneous 40MG/0.4ML Autoinjector FDA marketing: Rx	2016 DEEP_REVIEW FINAL	66
adalimumab Humira	125057 Product 125057/008	Injection · Subcutaneous 80MG/0.8ML Pre-Filled Syringe FDA marketing: Rx	2016 DEEP_REVIEW FINAL	66
adalimumab Humira	125057 Product 125057/009	Injection · Subcutaneous 80MG/0.8ML Autoinjector FDA marketing: Rx	2016 DEEP_REVIEW FINAL	66
adalimumab Humira	125057 Product 125057/010	Injection · Subcutaneous 20MG/0.2ML Pre-Filled Syringe FDA marketing: Rx	2016 DEEP_REVIEW FINAL	66
adalimumab Humira	125057 Product 125057/011	Injection · Subcutaneous 10MG/0.1ML Pre-Filled Syringe FDA marketing: Rx	2016 DEEP_REVIEW FINAL	66
adalimumab-aacf Idacio	761255 Product 761255/001	Injection · Subcutaneous 40MG/0.8ML Autoinjector FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	0
adalimumab-aaty Yuflyma	761219 Product 761219/001	Injection · Subcutaneous 40MG/0.4ML Autoinjector FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
adalimumab-adaz Hyrimoz	761071 Product 761071/001	Injection · Subcutaneous 40MG/0.8ML Pre-Filled Syringe FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
adalimumab-adbm Cyltezo	761058 Product 761058/001	Injection · Subcutaneous 40MG/0.8ML Pre-Filled Syringe FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
adalimumab-afzb Abrilada	761118 Product 761118/001	Injection · Subcutaneous 40MG/0.8ML Autoinjector FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
adalimumab-afzb Abrilada	761118 Product 761118/003	Injection · Subcutaneous 20MG/0.4ML Pre-Filled Syringe FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
adalimumab-afzb Abrilada	761118 Product 761118/004	Injection · Subcutaneous 10MG/0.2ML Pre-Filled Syringe FDA marketing: Prescription	2024 DISCONTINUED FINAL	0
adalimumab-aqvh Yusimry	761216 Product 761216/001	Injection · Subcutaneous 40MG/0.8ML Pre-Filled Syringe FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
adalimumab-atto Amjevita	761024 Product 761024/001	Injection · Subcutaneous 20MG/0.4ML Pre-Filled Syringe FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
adalimumab-atto Amjevita	761024 Product 761024/002	Injection · Subcutaneous 40MG/0.8ML Pre-Filled Syringe FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
adalimumab-bwwd Hadlima	761059 Product 761059/001	Injection · Subcutaneous 40MG/0.8ML Autoinjector FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
adalimumab-fkjp Hulio	761154 Product 761154/003	Injection · Subcutaneous 20MG/0.4ML Pre-Filled Syringe FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
adalimumab-ryvk Simlandi	761299 Product 761299/001	Injection · Subcutaneous 40MG/0.4ML Autoinjector FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
ADAPALENE DIFFERIN	020380 Product 020380/002	GEL · TOPICAL 0.1% FDA marketing: Over-the-counter	2016 EXCLUDED FINAL	0
ADAPALENE DIFFERIN	022502 Product 022502/001	LOTION · TOPICAL 0.1% FDA marketing: Discontinued	2024 DISCONTINUED FINAL	3
ADAPALENE, BENZOYL PEROXIDE DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE)	220736 Product 220736/002	GEL 15G FDA marketing: Over-the-counter	2027 CANDIDATE FINAL	1
ADAPALENE, BENZOYL PEROXIDE DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE)	220736 Product 220736/003	GEL 30G FDA marketing: Over-the-counter	2027 CANDIDATE FINAL	1
ADAPALENE, BENZOYL PEROXIDE DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE)	220736 Product 220736/004	GEL 45G FDA marketing: Over-the-counter	2027 CANDIDATE FINAL	1
ADAPALENE; BENZOYL PEROXIDE DIFFERIN EPIDUO	220736 Product 220736/001	GEL · TOPICAL 0.1%;2.5% FDA marketing: Over-the-counter	2026 EXCLUDED FINAL	0
ADAPALENE; BENZOYL PEROXIDE EPIDUO FORTE	207917 Product 207917/001	GEL · TOPICAL 0.3%;2.5% FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE CABTREO	216632 Product 216632/001	GEL · TOPICAL 0.15%;3.1%;1.2% FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	9
ado-trastuzumab emtansine Kadcyla	125427 Product 125427/001	For Injection · Intravenous 100MG Single-Dose Vial FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
ado-trastuzumab emtansine Kadcyla	125427 Product 125427/002	For Injection · Intravenous 160MG Single-Dose Vial FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
aducanumab-avwa Aduhelm	761178 Product 761178/001	Injection · Intravenous 170MG/1.7ML (100MG/ML) Single-Dose Vial FDA marketing: Prescription	2024 WITHDRAWN FINAL_CHECKING	2
aducanumab-avwa Aduhelm	761178 Product 761178/002	Injection · Intravenous 300MG/3ML (100MG/ML) Single-Dose Vial FDA marketing: Prescription	2024 WITHDRAWN FINAL_CHECKING	2
AFAMELANOTIDE SCENESSE	210797 Product 210797/001	IMPLANT · SUBCUTANEOUS 16MG FDA marketing: Prescription	2033 CANDIDATE FINAL	1
AFATINIB DIMALEATE GILOTRIF	201292 Product 201292/001	TABLET · ORAL EQ 20MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	5
AFATINIB DIMALEATE GILOTRIF	201292 Product 201292/002	TABLET · ORAL EQ 30MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	5
AFATINIB DIMALEATE GILOTRIF	201292 Product 201292/003	TABLET · ORAL EQ 40MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	5
AFICAMTEN MYQORZO	219083 Product 219083/001	TABLET · ORAL 5MG FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	2
AFICAMTEN MYQORZO	219083 Product 219083/002	TABLET · ORAL 10MG FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	2
AFICAMTEN MYQORZO	219083 Product 219083/003	TABLET · ORAL 15MG FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	2
AFICAMTEN MYQORZO	219083 Product 219083/004	TABLET · ORAL 20MG FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	2
aflibercept Eylea	125387 Product 125387/001	Injection · Intravitreal 2MG/0.05ML Single-Dose Vial FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	88
aflibercept Eylea HD	761355 Product 761355/001	Injection · Intravitreal 8MG/0.07ML Single-Dose Vial FDA marketing: Prescription	2024 DEEP_REVIEW FINAL_CHECKING	6
aflibercept-abzv Enzeevu	761382 Product 761382/001	Injection · Intravitreal 2MG/0.05ML Single-Dose Vial FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
aflibercept-ayyh Pavblu	761298 Product 761298/001	Injection · Intravitreal 2MG/0.05ML Single-Dose Vial FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
aflibercept-boav Eydenzelt	761377 Product 761377/001	Injection · Intravitreal 2MG/0.05ML Single-Dose Vial FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
aflibercept-jbvf Yesafili	761274 Product 761274/001	Injection · Intravitreal 2MG/0.05ML Single-Dose Vial FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
aflibercept-mrbb Ahzantive	761378 Product 761378/001	Injection · Intravitreal 2MG/0.05ML Single-Dose Vial FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
aflibercept-yszy Opuviz	761350 Product 761350/001	Injection · Intravitreal 2MG/0.05ML Single-Dose Vial FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
AIR AIR	221287 Product 221287/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
AIR AIR	221805 Product 221805/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
AIR POLYMER-TYPE A EXEM FOAM KIT	212279 Product 212279/001	FOAM · INTRAUTERINE 10ML FDA marketing: Prescription	2019 EXCLUDED FINAL	3
albiglutide Tanzeum	125431 Product 125431/001	For Injection · Subcutaneous 30MG Autoinjector FDA marketing: Discontinued	2020 WITHDRAWN FINAL	0
ALBUTEROL SULFATE PROAIR DIGIHALER	205636 Product 205636/002	POWDER, METERED · INHALATION EQ 0.09MG BASE/INH FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	27
ALBUTEROL SULFATE PROAIR RESPICLICK	205636 Product 205636/001	POWDER, METERED · INHALATION EQ 0.09MG BASE/INH FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	18
ALBUTEROL SULFATE; BUDESONIDE AIRSUPRA	214070 Product 214070/001	AEROSOL, METERED · INHALATION EQ 0.09MG BASE/INH;0.08MG/INH FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	1
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE COMBIVENT RESPIMAT	021747 Product 021747/001	SPRAY, METERED · INHALATION EQ 0.1MG BASE/INH;0.02MG/INH FDA marketing: Prescription	2014 DEEP_REVIEW FINAL_CHECKING	4
ALCAFTADINE LASTACAFT	022134 Product 022134/001	SOLUTION/DROPS · OPHTHALMIC 0.25% FDA marketing: Over-the-counter	2010 EXCLUDED FINAL	2
ALECTINIB HYDROCHLORIDE ALECENSA	208434 Product 208434/001	CAPSULE · ORAL EQ 150MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	5
ALENDRONATE SODIUM BINOSTO	202344 Product 202344/001	TABLET, EFFERVESCENT · ORAL EQ 70MG BASE FDA marketing: Discontinued	2012 DEEP_REVIEW FINAL_CHECKING	1
alglucosidase alfa Lumizyme	125291 Product 125291/001	For Injection · Intravenous 50MG Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
alirocumab Praluent	125559 Product 125559/001	Injection · Subcutaneous 75MG/ML Autoinjector FDA marketing: Prescription	2029 CANDIDATE FINAL	0
alirocumab Praluent	125559 Product 125559/002	Injection · Subcutaneous 150MG/ML Autoinjector FDA marketing: Prescription	2029 CANDIDATE FINAL	0
ALISKIREN HEMIFUMARATE TEKTURNA	210709 Product 210709/001	CAPSULE, PELLET · ORAL EQ 37.5MG BASE FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE TEKAMLO	022545 Product 022545/001	TABLET · ORAL EQ 150MG BASE;EQ 5MG BASE FDA marketing: Discontinued	2018 DEEP_REVIEW FINAL_CHECKING	1
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE TEKAMLO	022545 Product 022545/002	TABLET · ORAL EQ 150MG BASE;EQ 10MG BASE FDA marketing: Discontinued	2018 DEEP_REVIEW FINAL_CHECKING	1
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE TEKAMLO	022545 Product 022545/003	TABLET · ORAL EQ 300MG BASE;EQ 5MG BASE FDA marketing: Discontinued	2018 DEEP_REVIEW FINAL_CHECKING	1
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE TEKAMLO	022545 Product 022545/004	TABLET · ORAL EQ 300MG BASE;EQ 10MG BASE FDA marketing: Discontinued	2018 DEEP_REVIEW FINAL_CHECKING	1
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE AMTURNIDE	200045 Product 200045/001	TABLET · ORAL EQ 150MG BASE;EQ 5MG BASE;12.5MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	3
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE AMTURNIDE	200045 Product 200045/002	TABLET · ORAL EQ 300MG BASE;EQ 5MG BASE;12.5MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	3
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE AMTURNIDE	200045 Product 200045/003	TABLET · ORAL EQ 300MG BASE;EQ 5MG BASE;25MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	3
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE AMTURNIDE	200045 Product 200045/004	TABLET · ORAL EQ 300MG BASE;EQ 10MG BASE;12.5MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	3
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE AMTURNIDE	200045 Product 200045/005	TABLET · ORAL EQ 300MG BASE;EQ 10MG BASE;25MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	3
ALLOPURINOL ZYLOPRIM	016084 Product 016084/003	TABLET · ORAL 200MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
ALLOPURINOL; LESINURAD DUZALLO	209203 Product 209203/001	TABLET · ORAL 200MG;200MG FDA marketing: DISCONTINUED	2019 DISQUALIFIED FINAL	8
ALLOPURINOL; LESINURAD DUZALLO	209203 Product 209203/002	TABLET · ORAL 300MG;200MG FDA marketing: DISCONTINUED	2019 DISQUALIFIED FINAL	8
ALOGLIPTIN BENZOATE NESINA	022271 Product 022271/001	TABLET · ORAL EQ 6.25MG BASE FDA marketing: RX	2028 DEEP_REVIEW FINAL	2
ALOGLIPTIN BENZOATE NESINA	022271 Product 022271/002	TABLET · ORAL EQ 12.5MG BASE FDA marketing: RX	2028 DEEP_REVIEW FINAL	2
ALOGLIPTIN BENZOATE NESINA	022271 Product 022271/003	TABLET · ORAL EQ 25MG BASE FDA marketing: RX	2028 DEEP_REVIEW FINAL	2
ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE KAZANO	203414 Product 203414/001	TABLET · ORAL EQ 12.5MG BASE;500MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	2
ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE KAZANO	203414 Product 203414/002	TABLET · ORAL EQ 12.5MG BASE;1GM FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	2
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE OSENI	022426 Product 022426/001	TABLET · ORAL EQ 25MG BASE;EQ 15MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	2
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE OSENI	022426 Product 022426/002	TABLET · ORAL EQ 25MG BASE;EQ 30MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	2
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE OSENI	022426 Product 022426/003	TABLET · ORAL EQ 25MG BASE;EQ 45MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	2
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE OSENI	022426 Product 022426/004	TABLET · ORAL EQ 12.5MG BASE;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2022 DISQUALIFIED FINAL	2
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE OSENI	022426 Product 022426/005	TABLET · ORAL EQ 12.5MG BASE;EQ 30MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	2
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE OSENI	022426 Product 022426/006	TABLET · ORAL EQ 12.5MG BASE;EQ 45MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2022 DISQUALIFIED FINAL	2
ALPELISIB PIQRAY	212526 Product 212526/001	TABLET · ORAL 50MG FDA marketing: Prescription	2033 CANDIDATE FINAL	2
ALPELISIB PIQRAY	212526 Product 212526/002	TABLET · ORAL 150MG FDA marketing: Prescription	2033 CANDIDATE FINAL	2
ALPELISIB PIQRAY	212526 Product 212526/003	TABLET · ORAL 200MG FDA marketing: Prescription	2033 CANDIDATE FINAL	2
ALPELISIB VIJOICE	215039 Product 215039/001	TABLET · ORAL 50MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	4
ALPELISIB VIJOICE	215039 Product 215039/002	TABLET · ORAL 125MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	4
ALPELISIB VIJOICE	215039 Product 215039/003	TABLET · ORAL 200MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	4
ALPELISIB VIJOICE	218466 Product 218466/001	GRANULE · ORAL 50MG/PACKET FDA marketing: Prescription	Master only	4
AMANTADINE HYDROCHLORIDE GOCOVRI	208944 Product 208944/001	CAPSULE, EXTENDED RELEASE · ORAL EQ 68.5MG BASE FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	13
AMANTADINE HYDROCHLORIDE GOCOVRI	208944 Product 208944/002	CAPSULE, EXTENDED RELEASE · ORAL EQ 137MG BASE FDA marketing: Prescription	2020 DEEP_REVIEW FINAL_CHECKING	13
AMANTADINE HYDROCHLORIDE OSMOLEX ER	209410 Product 209410/001	TABLET, EXTENDED RELEASE · ORAL EQ 129MG BASE FDA marketing: Discontinued	2024 DISCONTINUED FINAL	9
AMANTADINE HYDROCHLORIDE OSMOLEX ER	209410 Product 209410/002	TABLET, EXTENDED RELEASE · ORAL EQ 193MG BASE FDA marketing: Discontinued	2024 DISCONTINUED FINAL	9
AMANTADINE HYDROCHLORIDE OSMOLEX ER	209410 Product 209410/003	TABLET, EXTENDED RELEASE · ORAL EQ 258MG BASE FDA marketing: Discontinued	2021 DISCONTINUED FINAL	8
AMANTADINE HYDROCHLORIDE OSMOLEX ER	209410 Product 209410/004	TABLET, EXTENDED RELEASE · ORAL EQ 161MG BASE FDA marketing: Discontinued	2025 WITHDRAWN FINAL	8
AMIFAMPRIDINE PHOSPHATE FIRDAPSE	208078 Product 208078/001	TABLET · ORAL EQ 10MG BASE FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	6
AMIKACIN SULFATE ARIKAYCE KIT	207356 Product 207356/001	SUSPENSION, LIPOSOMAL · INHALATION EQ 590MG BASE/8.4ML FDA marketing: Prescription	2030 DEEP_REVIEW FINAL_CHECKING	14
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL KABIVEN IN PLASTIC CONTAINER	200656 Product 200656/004	EMULSION · INTRAVENOUS 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML) FDA marketing: Prescription	2014 DEEP_REVIEW FINAL_CHECKING	1
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL KABIVEN IN PLASTIC CONTAINER	200656 Product 200656/005	EMULSION · INTRAVENOUS 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML) FDA marketing: Prescription	2014 DEEP_REVIEW FINAL_CHECKING	1
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL KABIVEN IN PLASTIC CONTAINER	200656 Product 200656/006	EMULSION · INTRAVENOUS 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML) FDA marketing: Prescription	2014 DEEP_REVIEW FINAL_CHECKING	1
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL KABIVEN IN PLASTIC CONTAINER	200656 Product 200656/007	EMULSION · INTRAVENOUS 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML) FDA marketing: Prescription	2014 DEEP_REVIEW FINAL_CHECKING	1
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL PERIKABIVEN IN PLASTIC CONTAINER	200656 Product 200656/001	EMULSION · INTRAVENOUS 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML) FDA marketing: Prescription	2014 DEEP_REVIEW FINAL_CHECKING	1
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL PERIKABIVEN IN PLASTIC CONTAINER	200656 Product 200656/002	EMULSION · INTRAVENOUS 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML) FDA marketing: Prescription	2014 DEEP_REVIEW FINAL_CHECKING	1
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL PERIKABIVEN IN PLASTIC CONTAINER	200656 Product 200656/003	EMULSION · INTRAVENOUS 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML) FDA marketing: Prescription	2014 DEEP_REVIEW FINAL_CHECKING	1
AMINO ACIDS; DEXTROSE CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER	020734 Product 020734/019	INJECTABLE · INJECTION 8%;14GM/100ML FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	0
AMINOLEVULINIC ACID HYDROCHLORIDE AMELUZ	208081 Product 208081/001	GEL · TOPICAL 10% FDA marketing: Prescription	2019 DEEP_REVIEW FINAL_CHECKING	3
AMINOLEVULINIC ACID HYDROCHLORIDE GLEOLAN	208630 Product 208630/001	FOR SOLUTION · ORAL 1.5GM/VIAL FDA marketing: Prescription	2017 EXCLUDED PROVISIONAL	0
AMIODARONE HYDROCHLORIDE NEXTERONE	022325 Product 022325/002	INJECTABLE · INJECTION 150MG/100ML (1.5MG/ML) FDA marketing: Prescription	2010 DEEP_REVIEW FINAL_CHECKING	6
AMIODARONE HYDROCHLORIDE NEXTERONE	022325 Product 022325/003	INJECTABLE · INJECTION 360MG/200ML (1.8MG/ML) FDA marketing: Prescription	2010 DEEP_REVIEW FINAL_CHECKING	6
AMISULPRIDE BARHEMSYS	209510 Product 209510/001	SOLUTION · INTRAVENOUS 5MG/2ML (2.5MG/ML) FDA marketing: Prescription	2034 DEEP_REVIEW FINAL_CHECKING	8
AMISULPRIDE BARHEMSYS	209510 Product 209510/002	SOLUTION · INTRAVENOUS 10MG/4ML (2.5MG/ML) FDA marketing: Prescription	2034 DEEP_REVIEW FINAL_CHECKING	8
amivantamab and hyaluronidase-lpuj Rybrevant Faspro	761484 Product 761484/001	Injection · Subcutaneous 1,600MG/10ML; 20,000UNITS/10ML (160MG/2,000UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2033 CANDIDATE FINAL_CHECKING	1
amivantamab and hyaluronidase-lpuj Rybrevant Faspro	761484 Product 761484/002	Injection · Subcutaneous 2,240MG/14ML; 28,000UNITS/14ML (160MG/2,000UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2033 CANDIDATE FINAL_CHECKING	1
amivantamab and hyaluronidase-lpuj Rybrevant Faspro	761484 Product 761484/003	Injection · Subcutaneous 2,400MG/15ML; 30,000UNITS (160MG/2,000UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2033 CANDIDATE FINAL_CHECKING	1
amivantamab and hyaluronidase-lpuj Rybrevant Faspro	761484 Product 761484/004	Injection · Subcutaneous 3,520MG/22ML; 44,000UNITS (160MG/2,000UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2033 CANDIDATE FINAL_CHECKING	1
amivantamab-vmjw Rybrevant	761210 Product 761210/001	Injection · Intravenous 350MG/7ML (50MG/ML) Single-Dose Vial FDA marketing: Prescription	2033 CANDIDATE FINAL_CHECKING	1
AMLODIPINE BENZOATE KATERZIA	211340 Product 211340/001	SUSPENSION · ORAL EQ 1MG BASE/ML FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	14
AMLODIPINE BESYLATE AMLODIPINE BESYLATE	210489 Product 210489/001	TABLET · ORAL EQ 2.5MG BASE FDA marketing: Prescription	Master only	0
AMLODIPINE BESYLATE AMLODIPINE BESYLATE	210489 Product 210489/002	TABLET · ORAL EQ 5MG BASE FDA marketing: Prescription	Master only	0
AMLODIPINE BESYLATE AMLODIPINE BESYLATE	210489 Product 210489/003	TABLET · ORAL EQ 10MG BASE FDA marketing: Prescription	Master only	0
AMLODIPINE BESYLATE NORLIQVA	214439 Product 214439/001	SOLUTION · ORAL EQ 1MG BASE/ML FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	6
AMLODIPINE BESYLATE SDAMLO	219531 Product 219531/001	FOR SOLUTION · ORAL EQ 2.5MG BASE/BOT FDA marketing: Prescription	2007 DEEP_REVIEW FINAL	1
AMLODIPINE BESYLATE SDAMLO	219531 Product 219531/002	FOR SOLUTION · ORAL EQ 5MG BASE/BOT FDA marketing: Prescription	2007 DEEP_REVIEW FINAL	1
AMLODIPINE BESYLATE SDAMLO	219531 Product 219531/003	FOR SOLUTION · ORAL EQ 10MG BASE/BOT FDA marketing: Prescription	2007 DEEP_REVIEW FINAL	1
AMLODIPINE BESYLATE; CELECOXIB CONSENSI	210045 Product 210045/001	TABLET · ORAL EQ 2.5MG BASE;200MG FDA marketing: Discontinued	2021 DISCONTINUED FINAL	1
AMLODIPINE BESYLATE; CELECOXIB CONSENSI	210045 Product 210045/002	TABLET · ORAL EQ 5MG BASE;200MG FDA marketing: Discontinued	2021 DISCONTINUED FINAL	1
AMLODIPINE BESYLATE; CELECOXIB CONSENSI	210045 Product 210045/003	TABLET · ORAL EQ 10MG BASE;200MG FDA marketing: Discontinued	2021 DISCONTINUED FINAL	1
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TRIBENZOR	200175 Product 200175/001	TABLET · ORAL EQ 5MG BASE;12.5MG;20MG FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TRIBENZOR	200175 Product 200175/002	TABLET · ORAL EQ 5MG BASE;12.5MG;40MG FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TRIBENZOR	200175 Product 200175/003	TABLET · ORAL EQ 5MG BASE;25MG;40MG FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TRIBENZOR	200175 Product 200175/004	TABLET · ORAL EQ 10MG BASE;12.5MG;40MG FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TRIBENZOR	200175 Product 200175/005	TABLET · ORAL EQ 10MG BASE;25MG;40MG FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN WIDAPLIK	219423 Product 219423/001	TABLET · ORAL EQ 1.25MG BASE;0.625MG;10MG FDA marketing: Discontinued	2026 DISCONTINUED FINAL	2
AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN WIDAPLIK	219423 Product 219423/002	TABLET · ORAL EQ 2.5MG BASE;1.25MG;20MG FDA marketing: Discontinued	2026 DISCONTINUED FINAL	2
AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN WIDAPLIK	219423 Product 219423/003	TABLET · ORAL EQ 5MG BASE;2.5MG;40MG FDA marketing: Discontinued	2026 DISCONTINUED FINAL	1
AMLODIPINE BESYLATE; PERINDOPRIL ARGININE PRESTALIA	205003 Product 205003/001	TABLET · ORAL EQ 2.5MG BASE;3.5MG FDA marketing: Discontinued	Master only	1
AMLODIPINE BESYLATE; PERINDOPRIL ARGININE PRESTALIA	205003 Product 205003/002	TABLET · ORAL EQ 5MG BASE;7MG FDA marketing: Discontinued	Master only	1
AMLODIPINE BESYLATE; PERINDOPRIL ARGININE PRESTALIA	205003 Product 205003/003	TABLET · ORAL EQ 10MG BASE;14MG FDA marketing: Discontinued	Master only	1
AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE OMECLAMOX-PAK	050824 Product 050824/001	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE · ORAL 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	0
AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE VOQUEZNA TRIPLE PAK	215152 Product 215152/001	CAPSULE, TABLET, TABLET · ORAL 500MG;500MG;EQ 20MG BASE FDA marketing: Prescription	2032 CANDIDATE FINAL	2
AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN TALICIA	213004 Product 213004/001	CAPSULE, DELAYED RELEASE · ORAL 250MG;EQ 10MG BASE;12.5MG FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	7
AMOXICILLIN; VONOPRAZAN FUMARATE VOQUEZNA DUAL PAK	215153 Product 215153/001	CAPSULE, TABLET · ORAL 500MG;EQ 20MG BASE FDA marketing: Prescription	2032 CANDIDATE FINAL	2
AMPHETAMINE ADZENYS ER	204325 Product 204325/001	SUSPENSION, EXTENDED RELEASE · ORAL EQ 1.25MG BASE/ML FDA marketing: Discontinued	2021 DISCONTINUED FINAL	3
AMPHETAMINE ADZENYS XR-ODT	204326 Product 204326/001	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL EQ 3.1MG BASE FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	5
AMPHETAMINE ADZENYS XR-ODT	204326 Product 204326/002	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL EQ 6.3MG BASE FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	5
AMPHETAMINE ADZENYS XR-ODT	204326 Product 204326/003	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL EQ 9.4MG BASE FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	5
AMPHETAMINE ADZENYS XR-ODT	204326 Product 204326/004	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL EQ 12.5MG BASE FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	5
AMPHETAMINE ADZENYS XR-ODT	204326 Product 204326/005	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL EQ 15.7MG BASE FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	5
AMPHETAMINE ADZENYS XR-ODT	204326 Product 204326/006	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL EQ 18.8MG BASE FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	5
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE MYDAYIS	022063 Product 022063/001	CAPSULE, EXTENDED RELEASE · ORAL 3.125MG;3.125MG;3.125MG;3.125MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	2
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE MYDAYIS	022063 Product 022063/002	CAPSULE, EXTENDED RELEASE · ORAL 6.25MG;6.25MG;6.25MG;6.25MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	2
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE MYDAYIS	022063 Product 022063/003	CAPSULE, EXTENDED RELEASE · ORAL 9.375MG;9.375MG;9.375MG;9.375MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	2
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE MYDAYIS	022063 Product 022063/004	CAPSULE, EXTENDED RELEASE · ORAL 12.5MG;12.5MG;12.5MG;12.5MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	2
AMPHETAMINE SULFATE EVEKEO ODT	209905 Product 209905/001	TABLET, ORALLY DISINTEGRATING · ORAL 5MG FDA marketing: Discontinued	2024 DISCONTINUED FINAL	3
AMPHETAMINE SULFATE EVEKEO ODT	209905 Product 209905/002	TABLET, ORALLY DISINTEGRATING · ORAL 10MG FDA marketing: Discontinued	2024 DISCONTINUED FINAL	3
AMPHETAMINE SULFATE EVEKEO ODT	209905 Product 209905/003	TABLET, ORALLY DISINTEGRATING · ORAL 15MG FDA marketing: Discontinued	2024 DISCONTINUED FINAL	3
AMPHETAMINE SULFATE EVEKEO ODT	209905 Product 209905/004	TABLET, ORALLY DISINTEGRATING · ORAL 20MG FDA marketing: Discontinued	2024 DISCONTINUED FINAL	3
AMPHETAMINE SULFATE EVEKEO ODT	209905 Product 209905/005	TABLET, ORALLY DISINTEGRATING · ORAL 2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2021 DISCONTINUED FINAL	2
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE DYANAVEL XR	208147 Product 208147/001	SUSPENSION, EXTENDED RELEASE · ORAL 2MG/ML;EQ 0.5MG BASE/ML FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	7
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE DYANAVEL XR 10	210526 Product 210526/002	TABLET, EXTENDED RELEASE · ORAL 8MG;EQ 2MG BASE FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	6
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE DYANAVEL XR 15	210526 Product 210526/003	TABLET, EXTENDED RELEASE · ORAL 12MG;EQ 3MG BASE FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	6
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE DYANAVEL XR 20	210526 Product 210526/004	TABLET, EXTENDED RELEASE · ORAL 16MG;EQ 4MG BASE FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	6
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE DYANAVEL XR 5	210526 Product 210526/001	TABLET, EXTENDED RELEASE · ORAL 4MG;EQ 1MG BASE FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	6
AMPHOTERICIN B AMPHOTERICIN B	220139 Product 220139/001	INJECTABLE, LIPOSOMAL · INJECTION 50MG/VIAL FDA marketing: Prescription	Master only	0
anacaulase-bcdb Nexobrid	761192 Product 761192/001	For Topical Gel · Topical 8.8% (1.94GM) Single-Use Jar FDA marketing: Prescription	DISCONTINUED FINAL	0
ANGIOTENSIN II ACETATE GIAPREZA	209360 Product 209360/001	SOLUTION · INTRAVENOUS EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	11
ANGIOTENSIN II ACETATE GIAPREZA	209360 Product 209360/002	SOLUTION · INTRAVENOUS EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) FDA marketing: Discontinued	2018 DISCONTINUED FINAL	11
ANGIOTENSIN II ACETATE GIAPREZA	209360 Product 209360/003	SOLUTION · INTRAVENOUS EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	11
anifrolumab-fnia Saphnelo	761123 Product 761123/001	Injection · Intravenous 300MG/2ML (150MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	4
anifrolumab-fnia Saphnelo	761451 Product 761451/002	Injection · Subcutaneous 120MG/0.8ML Autoinjector FDA marketing: Prescription	2033 CANDIDATE FINAL_CHECKING	4
ansuvimab-zykl Ebanga	761172 Product 761172/001	For Injection · Intravenous 400MG Single-Dose Vial FDA marketing: Prescription	2035 CANDIDATE FINAL	0
APALUTAMIDE ERLEADA	210951 Product 210951/001	TABLET · ORAL 60MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	14
APALUTAMIDE ERLEADA	210951 Product 210951/002	TABLET · ORAL 240MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	14
apitegromab-mstn Isembyld	761463 Product 761463/001	Injection · Intravenous 150MG/3ML (50MG/ML) Single-Dose Vial FDA marketing: Prescription	2038 CANDIDATE FINAL_CHECKING	1
APIXABAN ELIQUIS	202155 Product 202155/001	TABLET · ORAL 2.5MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	2
APIXABAN ELIQUIS	202155 Product 202155/002	TABLET · ORAL 5MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	2
APIXABAN ELIQUIS 0.5 MG TABLET FOR SUSPENSION	202155 Product 202155/003	TABLET, FOR SUSPENSION · ORAL 0.5MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	2
APIXABAN ELIQUIS SPRINKLE	220073 Product 220073/001	FOR SUSPENSION · ORAL 0.15MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	2
APOMORPHINE HYDROCHLORIDE KYNMOBI	210875 Product 210875/001	FILM · SUBLINGUAL 10MG FDA marketing: Discontinued	2025 WITHDRAWN FINAL	12
APOMORPHINE HYDROCHLORIDE KYNMOBI	210875 Product 210875/002	FILM · SUBLINGUAL 15MG FDA marketing: Discontinued	2025 WITHDRAWN FINAL	12
APOMORPHINE HYDROCHLORIDE KYNMOBI	210875 Product 210875/003	FILM · SUBLINGUAL 20MG FDA marketing: Discontinued	2025 WITHDRAWN FINAL	12
APOMORPHINE HYDROCHLORIDE KYNMOBI	210875 Product 210875/004	FILM · SUBLINGUAL 25MG FDA marketing: Discontinued	2025 WITHDRAWN FINAL	12
APOMORPHINE HYDROCHLORIDE KYNMOBI	210875 Product 210875/005	FILM · SUBLINGUAL 30MG FDA marketing: Discontinued	2025 WITHDRAWN FINAL	12
APOMORPHINE HYDROCHLORIDE ONAPGO	214056 Product 214056/001	SOLUTION · SUBCUTANEOUS 98MG/20ML (4.9MG/ML) FDA marketing: Prescription	2028 CANDIDATE FINAL	0
APRACLONIDINE BRYTLY	220341 Product 220341/001	SOLUTION/DROPS · OPHTHALMIC 0.125% FDA marketing: Over-the-counter	Master only	0
APREMILAST OTEZLA	205437 Product 205437/001	TABLET · ORAL 10MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	4
APREMILAST OTEZLA	205437 Product 205437/002	TABLET · ORAL 20MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	4
APREMILAST OTEZLA	205437 Product 205437/003	TABLET · ORAL 30MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	4
APREMILAST OTEZLA XR	210745 Product 210745/001	TABLET, EXTENDED RELEASE · ORAL 75MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	5
APREPITANT APONVIE	216457 Product 216457/001	EMULSION · INTRAVENOUS 32MG/4.4ML (7.2MG/ML) FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	14
APREPITANT APREPITANT	218754 Product 218754/001	EMULSION · INTRAVENOUS 130MG/18ML (7.2MG/ML) FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	4
APREPITANT CINVANTI	209296 Product 209296/001	EMULSION · INTRAVENOUS 130MG/18ML (7.2MG/ML) FDA marketing: Prescription	2017 DEEP_REVIEW FINAL_CHECKING	13
APREPITANT EMEND	207865 Product 207865/001	FOR SUSPENSION · ORAL 125MG/KIT FDA marketing: Discontinued	2026 DISCONTINUED FINAL	1
APROCITENTAN TRYVIO	217686 Product 217686/001	TABLET · ORAL 12.5MG FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	6
ARGATROBAN ARGATROBAN	201811 Product 201811/001	INJECTABLE · INJECTION 250MG/2.5ML (100MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
ARGATROBAN ARGATROBAN	203049 Product 203049/001	INJECTABLE · INJECTION 250MG/2.5ML (100MG/ML) FDA marketing: Prescription	2014 EXISTING_GENERIC DISQUALIFIED	0
ARGATROBAN ARGATROBAN	203049 Product 203049/002	INJECTABLE · INJECTION 50MG/50ML (1MG/ML) FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
ARGATROBAN ARGATROBAN IN 0.9% SODIUM CHLORIDE	206769 Product 206769/001	INJECTABLE · INTRAVENOUS 250MG/250ML (1MG/ML) FDA marketing: Discontinued	2020 DISCONTINUED FINAL	0
ARGATROBAN ARGATROBAN IN DEXTROSE	201743 Product 201743/001	SOLUTION · INTRAVENOUS 125MG/125ML (1MG/ML) FDA marketing: Discontinued	2011 DISCONTINUED FINAL	0
ARGATROBAN ARGATROBAN IN SODIUM CHLORIDE	022434 Product 022434/001	INJECTABLE · INTRAVENOUS 50MG/50ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2021 DISCONTINUED FINAL	2
ARGATROBAN ARGATROBAN IN SODIUM CHLORIDE	022485 Product 022485/001	INJECTABLE · INTRAVENOUS 125MG/125ML (1MG/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
ARGATROBAN ARGATROBAN IN SODIUM CHLORIDE	209552 Product 209552/001	SOLUTION · INTRAVENOUS 50MG/50ML (1MG/ML) FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	0
ARGATROBAN ARGATROBAN IN SODIUM CHLORIDE	212035 Product 212035/001	SOLUTION · INTRAVENOUS 50MG/50ML (1MG/ML) FDA marketing: Prescription	2005 CANDIDATE FINAL	0
ARIMOCLOMOL CITRATE MIPLYFFA	214927 Product 214927/001	CAPSULE · ORAL EQ 47MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	4
ARIMOCLOMOL CITRATE MIPLYFFA	214927 Product 214927/002	CAPSULE · ORAL EQ 62MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	4
ARIMOCLOMOL CITRATE MIPLYFFA	214927 Product 214927/003	CAPSULE · ORAL EQ 93MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	4
ARIMOCLOMOL CITRATE MIPLYFFA	214927 Product 214927/004	CAPSULE · ORAL EQ 124MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	4
ARIPIPRAZOLE ABILIFY ASIMTUFII	217006 Product 217006/001	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 720MG/2.4ML (300MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	4
ARIPIPRAZOLE ABILIFY ASIMTUFII	217006 Product 217006/002	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 960MG/3.2ML (300MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	4
ARIPIPRAZOLE ABILIFY MAINTENA KIT	202971 Product 202971/001	FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 300MG/VIAL FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	7
ARIPIPRAZOLE ABILIFY MAINTENA KIT	202971 Product 202971/002	FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 400MG/VIAL FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	7
ARIPIPRAZOLE ABILIFY MAINTENA KIT	202971 Product 202971/003	FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 300MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	7
ARIPIPRAZOLE ABILIFY MAINTENA KIT	202971 Product 202971/004	FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 400MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	7
ARIPIPRAZOLE ABILIFY MYCITE KIT	207202 Product 207202/001	TABLET · ORAL 2MG FDA marketing: Discontinued	DISCONTINUED FINAL	27
ARIPIPRAZOLE ABILIFY MYCITE KIT	207202 Product 207202/002	TABLET · ORAL 5MG FDA marketing: Discontinued	DISCONTINUED FINAL	27
ARIPIPRAZOLE ABILIFY MYCITE KIT	207202 Product 207202/003	TABLET · ORAL 10MG FDA marketing: Discontinued	DISCONTINUED FINAL	27
ARIPIPRAZOLE ABILIFY MYCITE KIT	207202 Product 207202/004	TABLET · ORAL 15MG FDA marketing: Discontinued	DISCONTINUED FINAL	27
ARIPIPRAZOLE ABILIFY MYCITE KIT	207202 Product 207202/005	TABLET · ORAL 20MG FDA marketing: Discontinued	DISCONTINUED FINAL	27
ARIPIPRAZOLE ABILIFY MYCITE KIT	207202 Product 207202/006	TABLET · ORAL 30MG FDA marketing: Discontinued	DISCONTINUED FINAL	27
ARIPIPRAZOLE MEZOFY	211448 Product 211448/001	FILM · ORAL 5MG FDA marketing: Discontinued	2025 DISCONTINUED FINAL	1
ARIPIPRAZOLE MEZOFY	211448 Product 211448/002	FILM · ORAL 10MG FDA marketing: Discontinued	2025 DISCONTINUED FINAL	1
ARIPIPRAZOLE MEZOFY	211448 Product 211448/003	FILM · ORAL 15MG FDA marketing: Discontinued	2025 DISCONTINUED FINAL	1
ARIPIPRAZOLE OPIPZA	216655 Product 216655/001	FILM · ORAL 2MG FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	2
ARIPIPRAZOLE OPIPZA	216655 Product 216655/002	FILM · ORAL 5MG FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	2
ARIPIPRAZOLE OPIPZA	216655 Product 216655/003	FILM · ORAL 10MG FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	2
ARIPIPRAZOLE LAUROXIL ARISTADA	207533 Product 207533/001	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 441MG/1.6ML (275.63MG/ML) FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	17
ARIPIPRAZOLE LAUROXIL ARISTADA	207533 Product 207533/002	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 662MG/2.4ML (275.83MG/ML) FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	18
ARIPIPRAZOLE LAUROXIL ARISTADA	207533 Product 207533/003	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 882MG/3.2ML (275.63MG/ML) FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	18
ARIPIPRAZOLE LAUROXIL ARISTADA	207533 Product 207533/004	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 1064MG/3.9ML (272.82MG/ML) FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	17
ARIPIPRAZOLE LAUROXIL ARISTADA INITIO KIT	209830 Product 209830/001	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 675MG/2.4ML (281.25MG/ML) FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	9
ARSENIC TRIOXIDE TRISENOX	021248 Product 021248/002	INJECTABLE · INJECTION 2MG/ML FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	0
ARTESUNATE ARTESUNATE	213036 Product 213036/001	POWDER · INTRAVENOUS 110MG/VIAL FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	2
ARTICAINE HYDROCHLORIDE CYKLX	218643 Product 218643/001	SOLUTION/DROPS · OPHTHALMIC EQ 8% BASE FDA marketing: Discontinued	2026 DISCONTINUED FINAL	3
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE ORABLOC	022466 Product 022466/001	INJECTABLE · INJECTION 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE ORABLOC	022466 Product 022466/002	INJECTABLE · INJECTION 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
ASCIMINIB HYDROCHLORIDE SCEMBLIX	215358 Product 215358/001	TABLET · ORAL EQ 20MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	4
ASCIMINIB HYDROCHLORIDE SCEMBLIX	215358 Product 215358/002	TABLET · ORAL EQ 40MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	4
ASCIMINIB HYDROCHLORIDE SCEMBLIX	215358 Product 215358/003	TABLET · ORAL EQ 100MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	4
ASCORBIC ACID ASCOR	209112 Product 209112/001	SOLUTION · INTRAVENOUS 25,000MG/50ML (500MG/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE PLENVU	209381 Product 209381/001	FOR SOLUTION · ORAL 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM FDA marketing: Discontinued	2026 DISCONTINUED FINAL	11
ASENAPINE SECUADO	212268 Product 212268/001	SYSTEM · TRANSDERMAL 3.8MG/24HR FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	6
ASENAPINE SECUADO	212268 Product 212268/002	SYSTEM · TRANSDERMAL 5.7MG/24HR FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	6
ASENAPINE SECUADO	212268 Product 212268/003	SYSTEM · TRANSDERMAL 7.6MG/24HR FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	6
ASENAPINE MALEATE SAPHRIS	022117 Product 022117/003	TABLET · SUBLINGUAL EQ 2.5MG BASE FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	2
asfotase alfa Strensiq	125513 Product 125513/001	Injection · Subcutaneous 18MG/0.45ML Single-Dose Vial FDA marketing: Prescription	2029 CANDIDATE FINAL	0
asfotase alfa Strensiq	125513 Product 125513/002	Injection · Subcutaneous 28MG/0.7ML Single-Dose Vial FDA marketing: Prescription	2029 CANDIDATE FINAL	0
asfotase alfa Strensiq	125513 Product 125513/003	Injection · Subcutaneous 40MG/ML Single-Dose Vial FDA marketing: Prescription	2029 CANDIDATE FINAL	0
asfotase alfa Strensiq	125513 Product 125513/004	Injection · Subcutaneous 80MG/0.8ML Single-Dose Vial FDA marketing: Prescription	2029 CANDIDATE FINAL	0
asparaginase erwinia chrysanthemi (recombinant)-rywn Rylaze	761179 Product 761179/001	Injection · Intramuscular 10MG/0.5ML Single-Dose Vial FDA marketing: Prescription	2033 DEEP_REVIEW FINAL_CHECKING	2
ASPIRIN DURLAZA	200671 Product 200671/001	CAPSULE, EXTENDED RELEASE · ORAL 162.5MG FDA marketing: Discontinued	2024 WITHDRAWN FINAL	0
ASPIRIN VAZALORE	203697 Product 203697/001	CAPSULE · ORAL 325MG FDA marketing: Over-the-counter	2013 EXCLUDED FINAL	4
ASPIRIN VAZALORE	203697 Product 203697/002	CAPSULE · ORAL 81MG FDA marketing: Over-the-counter	2021 EXCLUDED FINAL	2
ASPIRIN; OMEPRAZOLE YOSPRALA	205103 Product 205103/001	TABLET, DELAYED RELEASE · ORAL 81MG;40MG FDA marketing: Discontinued	2020 DISCONTINUED FINAL	2
ASPIRIN; OMEPRAZOLE YOSPRALA	205103 Product 205103/002	TABLET, DELAYED RELEASE · ORAL 325MG;40MG FDA marketing: Discontinued	2020 DISCONTINUED FINAL	2
atacicept-vymj Trutakna	761486 Product 761486/001	Injection · Subcutaneous 150MG/ML Autoinjector FDA marketing: Prescription	2038 CANDIDATE FINAL_CHECKING	1
ATAZANAVIR SULFATE REYATAZ	206352 Product 206352/001	POWDER · ORAL EQ 50MG BASE/PACKET FDA marketing: Prescription	2019 CANDIDATE FINAL	2
ATAZANAVIR SULFATE; COBICISTAT EVOTAZ	206353 Product 206353/001	TABLET · ORAL EQ 300MG BASE;150MG FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	2
atezolizumab Tecentriq	761034 Product 761034/001	Injection · Intravenous 1,200MG/20ML (60MG/ML) Single-Dose Vial FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	0
atezolizumab and hyaluronidase-tqjs Tecentriq Hybreza	761347 Product 761347/001	Injection · Subcutaneous 1,875MG/15ML; 30,000UNITS/15ML (125MG/2,000UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	0
ATOGEPANT QULIPTA	215206 Product 215206/001	TABLET · ORAL 10MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	9
ATOGEPANT QULIPTA	215206 Product 215206/002	TABLET · ORAL 30MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	7
ATOGEPANT QULIPTA	215206 Product 215206/003	TABLET · ORAL 60MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	6
atoltivimab, maftivimab, and odesivimab-ebgn Inmazeb	761169 Product 761169/001	Injection · Intravenous 241.7MG, 241.7MG, 241.7MG/14.5ML (16.67MG, 16.67MG, 16.67MG/ML) Single-Dose Vial FDA marketing: Prescription	DEEP_REVIEW FINAL	0
ATOMOXETINE HYDROCHLORIDE ATONCY	220320 Product 220320/001	SOLUTION · ORAL EQ 4MG BASE/ML FDA marketing: Prescription	2017 CANDIDATE FINAL	1
ATORVASTATIN CALCIUM ATORVALIQ	213260 Product 213260/001	SUSPENSION · ORAL 20MG/5ML FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	6
ATORVASTATIN CALCIUM; EZETIMIBE LIPTRUZET	200153 Product 200153/001	TABLET · ORAL EQ 10MG BASE;10MG FDA marketing: Discontinued	2015 DISCONTINUED FINAL	3
ATORVASTATIN CALCIUM; EZETIMIBE LIPTRUZET	200153 Product 200153/002	TABLET · ORAL EQ 20MG BASE;10MG FDA marketing: Discontinued	2015 DISCONTINUED FINAL	3
ATORVASTATIN CALCIUM; EZETIMIBE LIPTRUZET	200153 Product 200153/003	TABLET · ORAL EQ 40MG BASE;10MG FDA marketing: Discontinued	2015 DISCONTINUED FINAL	3
ATORVASTATIN CALCIUM; EZETIMIBE LIPTRUZET	200153 Product 200153/004	TABLET · ORAL EQ 80MG BASE;10MG FDA marketing: Discontinued	2015 DISCONTINUED FINAL	3
ATRASENTAN HYDROCHLORIDE VANRAFIA	219208 Product 219208/001	TABLET · ORAL EQ 0.75MG BASE FDA marketing: Prescription	2040 DEEP_REVIEW FINAL_CHECKING	10
ATROPINE ATROPINE (AUTOINJECTOR)	212319 Product 212319/001	SOLUTION · INTRAMUSCULAR EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) FDA marketing: Discontinued	2018 DEEP_REVIEW PROVISIONAL	0
ATROPINE SULFATE ATROPINE SULFATE	206289 Product 206289/001	SOLUTION/DROPS · OPHTHALMIC 1% FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
ATROPINE SULFATE ATROPINE SULFATE	209260 Product 209260/001	SOLUTION · INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL 8MG/20ML (0.4MG/ML) FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
ATROPINE SULFATE ATROPINE SULFATE	213581 Product 213581/001	SOLUTION/DROPS · OPHTHALMIC 1% FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
ATROPINE SULFATE ATROPINE SULFATE	214652 Product 214652/001	SOLUTION · INTRAVENOUS 0.4MG/ML (0.4MG/ML) FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
ATROPINE SULFATE ATROPINE SULFATE	214652 Product 214652/002	SOLUTION · INTRAVENOUS 1MG/ML (1MG/ML) FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
ATROPINE SULFATE ATROPINE SULFATE	219628 Product 219628/001	SOLUTION/DROPS · OPHTHALMIC 1% FDA marketing: Prescription	Master only	0
ATROPINE SULFATE ISOPTO ATROPINE	208151 Product 208151/001	SOLUTION/DROPS · OPHTHALMIC 1% FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
AVACINCAPTAD PEGOL SODIUM IZERVAY	217225 Product 217225/001	SOLUTION · INTRAVITREAL EQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML) FDA marketing: Prescription	2034 CANDIDATE FINAL	6
AVACOPAN TAVNEOS	214487 Product 214487/001	CAPSULE · ORAL 10MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	4
avalglucosidase alfa-ngpt Nexviazyme	761194 Product 761194/001	For Injection · Intravenous 100MG Single-Dose Vial FDA marketing: Prescription	2033 CANDIDATE FINAL_CHECKING	1
AVANAFIL STENDRA	202276 Product 202276/001	TABLET · ORAL 50MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
AVANAFIL STENDRA	202276 Product 202276/002	TABLET · ORAL 100MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
AVANAFIL STENDRA	202276 Product 202276/003	TABLET · ORAL 200MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
AVAPRITINIB AYVAKIT	212608 Product 212608/001	TABLET · ORAL 100MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	6
AVAPRITINIB AYVAKIT	212608 Product 212608/002	TABLET · ORAL 200MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	6
AVAPRITINIB AYVAKIT	212608 Product 212608/003	TABLET · ORAL 300MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	5
AVAPRITINIB AYVAKIT	212608 Product 212608/004	TABLET · ORAL 25MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	7
AVAPRITINIB AYVAKIT	212608 Product 212608/005	TABLET · ORAL 50MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	5
AVATROMBOPAG MALEATE DOPTELET	210238 Product 210238/001	TABLET · ORAL EQ 20MG BASE FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	1
AVATROMBOPAG MALEATE DOPTELET SPRINKLE	219696 Product 219696/001	GRANULE · ORAL EQ 10MG BASE FDA marketing: Prescription	2032 CANDIDATE FINAL	1
avelumab Bavencio	761049 Product 761049/001	Injection · Intravenous 200MG/10ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2033 CANDIDATE FINAL	0
AVIBACTAM SODIUM; AZTREONAM EMBLAVEO	217906 Product 217906/001	POWDER · INTRAVENOUS EQ 0.5GM BASE/VIAL;1.5GM/VIAL FDA marketing: Prescription	2033 CANDIDATE FINAL	7
AVIBACTAM SODIUM; CEFTAZIDIME AVYCAZ	206494 Product 206494/001	POWDER · INTRAVENOUS EQ 0.5GM BASE;2GM/VIAL FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	7
AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)	219616 Product 219616/001	CAPSULE, TABLET · ORAL EQ 0.8MG BASE;EQ 200MG BASE FDA marketing: Prescription	2040 DEEP_REVIEW FINAL	7
axatilimab-csfr Niktimvo	761411 Product 761411/001	Injection · Intravenous 50MG/ML Single-Dose Vial FDA marketing: Prescription	2026 DISCONTINUED FINAL	0
AXITINIB INLYTA	202324 Product 202324/001	TABLET · ORAL 1MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	4
AXITINIB INLYTA	202324 Product 202324/002	TABLET · ORAL 5MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	4
AZACITIDINE AZACITIDINE	208216 Product 208216/001	POWDER · INTRAVENOUS, SUBCUTANEOUS 100MG/VIAL FDA marketing: Prescription	2013 EXISTING_GENERIC DISQUALIFIED	0
AZACITIDINE ONUREG	214120 Product 214120/001	TABLET · ORAL 200MG FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	3
AZACITIDINE ONUREG	214120 Product 214120/002	TABLET · ORAL 300MG FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	3
AZELAIC ACID FINACEA	207071 Product 207071/001	AEROSOL, FOAM · TOPICAL 15% FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	4
AZELASTINE HYDROCHLORIDE ASTEPRO ALLERGY	213872 Product 213872/001	SPRAY, METERED · NASAL 0.2055MG/SPRAY FDA marketing: Over-the-counter	2021 EXCLUDED FINAL	1
AZELASTINE HYDROCHLORIDE CHILDREN'S ASTEPRO ALLERGY	213872 Product 213872/002	SPRAY, METERED · NASAL 0.2055MG/SPRAY FDA marketing: Over-the-counter	2021 EXCLUDED FINAL	1
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE DYMISTA	202236 Product 202236/001	SPRAY, METERED · NASAL 0.137MG/SPRAY;0.05MG/SPRAY FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	1
AZILSARTAN KAMEDOXOMIL EDARBI	200796 Product 200796/001	TABLET · ORAL EQ 40MG MEDOXOMIL FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	1
AZILSARTAN KAMEDOXOMIL EDARBI	200796 Product 200796/002	TABLET · ORAL EQ 80MG MEDOXOMIL FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	1
AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE EDARBYCLOR	202331 Product 202331/001	TABLET · ORAL EQ 40MG MEDOXOMIL;12.5MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	3
AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE EDARBYCLOR	202331 Product 202331/002	TABLET · ORAL EQ 40MG MEDOXOMIL;25MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	3
AZTREONAM CAYSTON	050814 Product 050814/001	FOR SOLUTION · INHALATION 75MG/VIAL FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	4
BACLOFEN FLEQSUVY	215602 Product 215602/001	SUSPENSION · ORAL 25MG/5ML FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	2
BACLOFEN GABLOFEN	022462 Product 022462/001	INJECTABLE · INTRATHECAL 0.05MG/ML FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
BACLOFEN GABLOFEN	022462 Product 022462/002	INJECTABLE · INTRATHECAL 0.5MG/ML FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
BACLOFEN GABLOFEN	022462 Product 022462/003	INJECTABLE · INTRATHECAL 2MG/ML FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
BACLOFEN GABLOFEN	022462 Product 022462/004	INJECTABLE · INTRATHECAL 1MG/ML FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
BACLOFEN LYVISPAH	215422 Product 215422/001	GRANULE · ORAL 5MG/PACKET FDA marketing: Discontinued	2025 DISCONTINUED FINAL	5
BACLOFEN LYVISPAH	215422 Product 215422/002	GRANULE · ORAL 10MG/PACKET FDA marketing: Discontinued	2025 DISCONTINUED FINAL	5
BACLOFEN LYVISPAH	215422 Product 215422/003	GRANULE · ORAL 20MG/PACKET FDA marketing: Discontinued	2025 DISCONTINUED FINAL	5
BACLOFEN OZOBAX	208193 Product 208193/001	SOLUTION · ORAL 5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
BACLOFEN OZOBAX DS	208193 Product 208193/002	SOLUTION · ORAL 10MG/5ML FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
BALOXAVIR MARBOXIL XOFLUZA	210854 Product 210854/001	TABLET · ORAL 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2023 DISQUALIFIED FINAL	9
BALOXAVIR MARBOXIL XOFLUZA	210854 Product 210854/002	TABLET · ORAL 40MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	9
BALOXAVIR MARBOXIL XOFLUZA	210854 Product 210854/003	TABLET · ORAL 80MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	9
BALOXAVIR MARBOXIL XOFLUZA	214410 Product 214410/001	FOR SUSPENSION · ORAL 2MG/ML FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	9
BALOXAVIR MARBOXIL XOFLUZA	214410 Product 214410/002	FOR SUSPENSION · ORAL 30MG/PACKET FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	9
BALOXAVIR MARBOXIL XOFLUZA	214410 Product 214410/003	FOR SUSPENSION · ORAL 40MG/PACKET FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	9
BALSALAZIDE DISODIUM GIAZO	022205 Product 022205/001	TABLET · ORAL 1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2019 DISCONTINUED FINAL	4
BARICITINIB OLUMIANT	207924 Product 207924/001	TABLET · ORAL 2MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	6
BARICITINIB OLUMIANT	207924 Product 207924/002	TABLET · ORAL 1MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	6
BARICITINIB OLUMIANT	207924 Product 207924/003	TABLET · ORAL 4MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	5
BARIUM SULFATE E-Z-CAT DRY	208036 Product 208036/003	FOR SUSPENSION · ORAL 40% FDA marketing: Discontinued	2017 EXCLUDED FINAL	0
BARIUM SULFATE E-Z-DISK	219840 Product 219840/001	TABLET · ORAL 700MG FDA marketing: Prescription	2025 EXCLUDED FINAL	0
BARIUM SULFATE E-Z-HD	208036 Product 208036/001	FOR SUSPENSION · ORAL 98% FDA marketing: Prescription	2016 EXCLUDED FINAL	0
BARIUM SULFATE E-Z-PAQUE	208036 Product 208036/002	FOR SUSPENSION · ORAL 96% FDA marketing: Prescription	2017 EXCLUDED FINAL	0
BARIUM SULFATE ENTERO VU 24%	208143 Product 208143/008	SUSPENSION · ORAL 24% FDA marketing: Prescription	2020 EXCLUDED FINAL	0
BARIUM SULFATE LIQUID E-Z-PAQUE	208143 Product 208143/003	SUSPENSION · ORAL 60% FDA marketing: Prescription	2017 EXCLUDED FINAL	0
BARIUM SULFATE READI-CAT 2	208143 Product 208143/001	SUSPENSION · ORAL 2% FDA marketing: Prescription	2016 EXCLUDED FINAL	0
BARIUM SULFATE READI-CAT 2 SMOOTHIE	208143 Product 208143/002	SUSPENSION · ORAL 2% FDA marketing: Prescription	2016 EXCLUDED FINAL	0
BARIUM SULFATE TAGITOL V	208143 Product 208143/005	SUSPENSION · ORAL 40% FDA marketing: Prescription	2017 EXCLUDED PROVISIONAL	0
BARIUM SULFATE VARIBAR HONEY	208143 Product 208143/007	SUSPENSION · ORAL 40% FDA marketing: Prescription	2018 EXCLUDED PROVISIONAL	0
BARIUM SULFATE VARIBAR NECTAR	208143 Product 208143/004	SUSPENSION · ORAL 40% FDA marketing: Prescription	2017 EXCLUDED PROVISIONAL	0
BARIUM SULFATE VARIBAR PUDDING	208844 Product 208844/001	PASTE · ORAL 40% FDA marketing: Prescription	2016 EXCLUDED FINAL	0
BARIUM SULFATE VARIBAR THIN HONEY	208143 Product 208143/006	SUSPENSION · ORAL 40% FDA marketing: Prescription	2018 EXCLUDED PROVISIONAL	0
BARIUM SULFATE VARIBAR THIN LIQUID	208036 Product 208036/004	FOR SUSPENSION · ORAL 81% FDA marketing: Prescription	2019 EXCLUDED FINAL	0
BAXDROSTAT BAXFENDY	219878 Product 219878/001	TABLET · ORAL 1MG FDA marketing: Prescription	2033 CANDIDATE FINAL	1
BAXDROSTAT BAXFENDY	219878 Product 219878/002	TABLET · ORAL 2MG FDA marketing: Prescription	2033 CANDIDATE FINAL	1
BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED DUAVEE	022247 Product 022247/001	TABLET · ORAL EQ 20MG BASE;0.45MG FDA marketing: Prescription	Master only	1
BECLOMETHASONE DIPROPIONATE BECLOMETHASONE DIPROPIONATE	214418 Product 214418/001	AEROSOL, METERED · INHALATION 0.04MG/INH FDA marketing: Prescription	Master only	0
BECLOMETHASONE DIPROPIONATE BECLOMETHASONE DIPROPIONATE	214418 Product 214418/002	AEROSOL, METERED · INHALATION 0.08MG/INH FDA marketing: Prescription	Master only	0
BECLOMETHASONE DIPROPIONATE QNASL	202813 Product 202813/001	AEROSOL, METERED · NASAL 0.08MG/ACTUATION FDA marketing: Prescription	2015 DEEP_REVIEW FINAL_CHECKING	1
BECLOMETHASONE DIPROPIONATE QNASL	202813 Product 202813/002	AEROSOL, METERED · NASAL 0.04MG/ACTUATION FDA marketing: Prescription	2017 DEEP_REVIEW FINAL_CHECKING	1
BECLOMETHASONE DIPROPIONATE QVAR REDIHALER	207921 Product 207921/001	AEROSOL, METERED · INHALATION 0.04MG/INH FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	15
BECLOMETHASONE DIPROPIONATE QVAR REDIHALER	207921 Product 207921/002	AEROSOL, METERED · INHALATION 0.08MG/INH FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	17
BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE TRIMBOW	219622 Product 219622/001	AEROSOL, METERED · INHALATION 0.086MG/INH;0.0049MG/INH;0.0106MG/INH FDA marketing: Discontinued	2026 DISCONTINUED FINAL	6
BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE TRIMBOW	219622 Product 219622/002	AEROSOL, METERED · INHALATION 0.172MG/INH;0.0049MG/INH;0.0106MG/INH FDA marketing: Discontinued	2026 DISCONTINUED FINAL	6
BEDAQUILINE FUMARATE SIRTURO	204384 Product 204384/001	TABLET · ORAL EQ 100MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	2
BEDAQUILINE FUMARATE SIRTURO	204384 Product 204384/002	TABLET · ORAL EQ 20MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	2
belantamab mafodotin-blmf Blenrep	761440 Product 761440/001	For Injection · Intravenous 70MG Single-Dose Vial FDA marketing: Prescription	2034 CANDIDATE FINAL_CHECKING	1
belatacept Nulojix	125288 Product 125288/001	For Injection · Intravenous 250MG Single-Dose Vial FDA marketing: Prescription	2025 CANDIDATE FINAL	0
belimumab Benlysta	125370 Product 125370/001	For Injection · Intravenous 120MG Single-Dose Vial FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
belimumab Benlysta	125370 Product 125370/002	For Injection · Intravenous 400MG Single-Dose Vial FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
belimumab Benlysta	761043 Product 761043/001	Injection · Subcutaneous 200MG/ML Autoinjector FDA marketing: Prescription	2025 CANDIDATE FINAL	0
BELINOSTAT BELEODAQ	206256 Product 206256/001	POWDER · INTRAVENOUS 500MG/VIAL FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	2
BELUMOSUDIL MESYLATE REZUROCK	214783 Product 214783/001	TABLET · ORAL EQ 200MG BASE FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	5
BELZUTIFAN WELIREG	215383 Product 215383/001	TABLET · ORAL 40MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	4
BEMPEDOIC ACID NEXLETOL	211616 Product 211616/001	TABLET · ORAL 180MG FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	7
BEMPEDOIC ACID; EZETIMIBE NEXLIZET	211617 Product 211617/001	TABLET · ORAL 180MG;10MG FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	8
BENDAMUSTINE HYDROCHLORIDE BELRAPZO	205580 Product 205580/001	SOLUTION · INTRAVENOUS 100MG/4ML (25MG/ML) FDA marketing: Prescription	2018 DEEP_REVIEW FINAL_CHECKING	11
BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE	211530 Product 211530/001	SOLUTION · INTRAVENOUS 25MG/ML (25MG/ML) FDA marketing: Discontinued	2023 DISQUALIFIED FINAL	1
BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE	211530 Product 211530/002	SOLUTION · INTRAVENOUS 100MG/4ML (25MG/ML) FDA marketing: Discontinued	2023 DISQUALIFIED FINAL	1
BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE	211530 Product 211530/003	SOLUTION · INTRAVENOUS 200MG/8ML (25MG/ML) FDA marketing: Discontinued	2023 DISQUALIFIED FINAL	1
BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE	215033 Product 215033/001	SOLUTION · INTRAVENOUS 100MG/4ML (25MG/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	1
BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE	216078 Product 216078/001	SOLUTION · INTRAVENOUS 100MG/4ML (25MG/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	1
BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE	219014 Product 219014/001	SOLUTION · INTRAVENOUS 100MG/4ML (25MG/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	1
BENDAMUSTINE HYDROCHLORIDE BENDEKA	208194 Product 208194/001	SOLUTION · INTRAVENOUS 100MG/4ML (25MG/ML) FDA marketing: Prescription	2033 CANDIDATE FINAL	20
BENDAMUSTINE HYDROCHLORIDE TREANDA	022249 Product 022249/003	SOLUTION · INTRAVENOUS 45MG/0.5ML (90MG/ML) FDA marketing: DISCONTINUED	2018 DISQUALIFIED FINAL	3
BENDAMUSTINE HYDROCHLORIDE TREANDA	022249 Product 022249/004	SOLUTION · INTRAVENOUS 180MG/2ML (90MG/ML) FDA marketing: DISCONTINUED	2018 DISQUALIFIED FINAL	3
BENDAMUSTINE HYDROCHLORIDE VIVIMUSTA	212209 Product 212209/001	SOLUTION · INTRAVENOUS 100MG/4ML (25MG/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	4
BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM ALTAFLUOR BENOX	208582 Product 208582/001	SOLUTION/DROPS · OPHTHALMIC 0.4%;0.25% FDA marketing: Prescription	2017 EXCLUDED PROVISIONAL	0
BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	211039 Product 211039/001	SOLUTION/DROPS · OPHTHALMIC 0.4%;0.3% FDA marketing: Prescription	2020 EXCLUDED FINAL	3
benralizumab Fasenra	761070 Product 761070/001	Injection · Subcutaneous 30MG/ML Pre-Filled Syringe FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	0
BENZGALANTAMINE GLUCONATE ZUNVEYL	218549 Product 218549/001	TABLET, DELAYED RELEASE · ORAL EQ 5MG BASE FDA marketing: Prescription	Master only	4
BENZGALANTAMINE GLUCONATE ZUNVEYL	218549 Product 218549/002	TABLET, DELAYED RELEASE · ORAL EQ 10MG BASE FDA marketing: Prescription	Master only	4
BENZGALANTAMINE GLUCONATE ZUNVEYL	218549 Product 218549/003	TABLET, DELAYED RELEASE · ORAL EQ 15MG BASE FDA marketing: Prescription	Master only	4
BENZNIDAZOLE BENZNIDAZOLE	209570 Product 209570/001	TABLET · ORAL 12.5MG FDA marketing: Prescription	2024 DEEP_REVIEW PROVISIONAL	0
BENZNIDAZOLE BENZNIDAZOLE	209570 Product 209570/002	TABLET · ORAL 100MG FDA marketing: Prescription	2024 DEEP_REVIEW PROVISIONAL	0
BENZOYL PEROXIDE EPSOLAY	214510 Product 214510/001	CREAM · TOPICAL 5% FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	14
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE ONEXTON	050819 Product 050819/002	GEL · TOPICAL 3.75%;EQ 1.2% BASE FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	5
BENZOYL PEROXIDE; TRETINOIN TWYNEO	214902 Product 214902/001	CREAM · TOPICAL 3%;0.1% FDA marketing: Prescription	2024 DEEP_REVIEW FINAL_CHECKING	13
BEPIROVIRSEN HIBSAGO	221276 Product 221276/001	SOLUTION · SUBCUTANEOUS 150MG/ML FDA marketing: Prescription	2026 NEW_APPROVAL PROVISIONAL	0
BERDAZIMER SODIUM ZELSUVMI	217424 Product 217424/001	GEL · TOPICAL EQ 10.3% BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	14
BEROTRALSTAT DIHYDROCHLORIDE ORLADEYO	214094 Product 214094/001	CAPSULE · ORAL EQ 110MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	16
BEROTRALSTAT DIHYDROCHLORIDE ORLADEYO	214094 Product 214094/002	CAPSULE · ORAL EQ 150MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	16
BEROTRALSTAT DIHYDROCHLORIDE ORLADEYO	219776 Product 219776/001	PELLETS · ORAL EQ 72MG BASE/PACKET FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	16
BEROTRALSTAT DIHYDROCHLORIDE ORLADEYO	219776 Product 219776/002	PELLETS · ORAL EQ 96MG BASE/PACKET FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	16
BEROTRALSTAT DIHYDROCHLORIDE ORLADEYO	219776 Product 219776/003	PELLETS · ORAL EQ 108MG BASE/PACKET FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	16
BEROTRALSTAT DIHYDROCHLORIDE ORLADEYO	219776 Product 219776/004	PELLETS · ORAL EQ 132MG BASE/PACKET FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	16
BETAMETHASONE DIPROPIONATE SERNIVO	208079 Product 208079/001	SPRAY · TOPICAL EQ 0.05% BASE/SPRAY FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	8
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE ENSTILAR	207589 Product 207589/001	AEROSOL, FOAM · TOPICAL 0.064%;0.005% FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	8
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE WYNZORA	213422 Product 213422/001	CREAM · TOPICAL 0.064%;0.005% FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	3
BETRIXABAN BEVYXXA	208383 Product 208383/001	CAPSULE · ORAL 40MG FDA marketing: DISCONTINUED	2020 DISQUALIFIED FINAL	5
BETRIXABAN BEVYXXA	208383 Product 208383/002	CAPSULE · ORAL 80MG FDA marketing: DISCONTINUED	2020 DISQUALIFIED FINAL	5
bevacizumab Avastin	125085 Product 125085/001	Injection · Intravenous 100MG/4ML (25MG/ML) Single-Dose Vial FDA marketing: Rx	2016 DEEP_REVIEW FINAL	22
bevacizumab Avastin	125085 Product 125085/002	Injection · Intravenous 400MG/16ML (25MG/ML) Single-Dose Vial FDA marketing: Rx	2016 DEEP_REVIEW FINAL	22
bevacizumab-adcd Vegzelma	761268 Product 761268/001	Injection · Intravenous 100MG/4ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
bevacizumab-adcd Vegzelma	761268 Product 761268/002	Injection · Intravenous 400MG/16ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
bevacizumab-awwb Mvasi	761028 Product 761028/001	Injection · Intravenous 100MG/4ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
bevacizumab-awwb Mvasi	761028 Product 761028/002	Injection · Intravenous 400MG/16ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
bevacizumab-bvzr Zirabev	761099 Product 761099/001	Injection · Intravenous 100MG/4ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
bevacizumab-bvzr Zirabev	761099 Product 761099/002	Injection · Intravenous 400MG/16ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
bevacizumab-maly Alymsys	761231 Product 761231/001	Injection · Intravenous 100MG/4ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
bevacizumab-maly Alymsys	761231 Product 761231/002	Injection · Intravenous 400MG/16ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
bevacizumab-nwgd Jobevne	761175 Product 761175/001	Injection · Intravenous 100MG/4ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
bevacizumab-nwgd Jobevne	761175 Product 761175/002	Injection · Intravenous 400MG/16ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
bevacizumab-tnjn Avzivi	761198 Product 761198/001	Injection · Intravenous 100MG/4ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
bevacizumab-tnjn Avzivi	761198 Product 761198/002	Injection · Intravenous 400MG/16ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
bevacizumab-vikg Lytenava	761320 Product 761320/001	Injection · Intravitreal 1.25MG (0.05ML of 25MG/ML) Single-Dose Vial FDA marketing: Prescription	2038 CANDIDATE FINAL_CHECKING	0
BEXAGLIFLOZIN BRENZAVVY	214373 Product 214373/001	TABLET · ORAL 20MG FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	7
bezlotoxumab Zinplava	761046 Product 761046/001	Injection · Intravenous 1,000MG/40ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2029 CANDIDATE FINAL	0
BICTEGRAVIR SODIUM, LENACAPAVIR SODIUM; LENACAPAVIR SODIUM BIXLENVO SUNLENCA STARTER PACK (COPACKAGED)	221443 Product 221443/001	TABLET · ORAL EQ 75MG BASE, EQ 50MG BASE; EQ 300MG BASE FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	8
BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE BIKTARVY	210251 Product 210251/001	TABLET · ORAL EQ 50MG BASE;200MG;EQ 25MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	9
BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE BIKTARVY	210251 Product 210251/002	TABLET · ORAL EQ 30MG BASE;120MG;EQ 15MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	7
BICTEGRAVIR SODIUM; LENACAPAVIR SODIUM BIXLENVO	221104 Product 221104/001	TABLET · ORAL EQ 75MG BASE;EQ 50MG BASE FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	8
BIMATOPROST DURYSTA	211911 Product 211911/001	IMPLANT · OPHTHALMIC 10MCG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	7
BIMATOPROST LUMIGAN	022184 Product 022184/001	SOLUTION/DROPS · OPHTHALMIC 0.01% FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
BIMATOPROST ZOLYMBUS	217307 Product 217307/001	GEL · OPHTHALMIC 0.01% FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	1
BIMEKIZUMAB-BKZX BIMZELX	761151 Product 761151/001	INJECTABLE · INJECTION 160ML FDA marketing: Prescription	Master only	0
BINIMETINIB MEKTOVI	210498 Product 210498/001	TABLET · ORAL 15MG FDA marketing: RX	2031 DEEP_REVIEW FINAL	7
BIRCH TRITERPENES FILSUVEZ	215064 Product 215064/001	GEL · TOPICAL 10% FDA marketing: Prescription	2030 DEEP_REVIEW FINAL_CHECKING	6
BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE HALFLYTELY	021551 Product 021551/003	FOR SOLUTION, TABLET, DELAYED RELEASE · ORAL 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	1
BIVALIRUDIN ANGIOMAX RTU	211215 Product 211215/001	SOLUTION · INTRAVENOUS 250MG/50ML (5MG/ML) FDA marketing: Prescription	2019 DEEP_REVIEW FINAL_CHECKING	4
BIVALIRUDIN BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	208374 Product 208374/001	SOLUTION · INTRAVENOUS 250MG/50ML (5MG/ML) FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
BIVALIRUDIN BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	208374 Product 208374/002	SOLUTION · INTRAVENOUS 500MG/100ML (5MG/ML) FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
blinatumomab Blincyto	125557 Product 125557/001	For Injection · Intravenous 35MCG Single-Dose Vial FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	0
BOCEPREVIR VICTRELIS	202258 Product 202258/001	CAPSULE · ORAL 200MG FDA marketing: Discontinued	2015 DISCONTINUED FINAL	2
BORTEZOMIB BORTEZOMIB	205004 Product 205004/001	POWDER · INTRAVENOUS 3.5MG/VIAL FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
BORTEZOMIB BORTEZOMIB	206927 Product 206927/001	POWDER · INTRAVENOUS 3.5MG/VIAL FDA marketing: Discontinued	2023 DISQUALIFIED FINAL	0
BORTEZOMIB BORTEZOMIB	209191 Product 209191/001	POWDER · INTRAVENOUS, SUBCUTANEOUS 1MG/VIAL FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	0
BORTEZOMIB BORTEZOMIB	209191 Product 209191/002	POWDER · INTRAVENOUS, SUBCUTANEOUS 2.5MG/VIAL FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	0
BORTEZOMIB BORTEZOMIB	212782 Product 212782/001	SOLUTION · INTRAVENOUS, SUBCUTANEOUS 3.5MG/1.4ML (2.5MG/ML) FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	3
BORTEZOMIB BORTEZOMIB	215331 Product 215331/001	SOLUTION · INTRAVENOUS 3.5MG/3.5ML (1MG/ML) FDA marketing: Discontinued	2022 DISCONTINUED FINAL	3
BORTEZOMIB BORTEZOMIB	215331 Product 215331/002	SOLUTION · INTRAVENOUS 3.5MG/1.4ML (2.5MG/ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	3
BORTEZOMIB BORTEZOMIB	215441 Product 215441/001	SOLUTION · INTRAVENOUS 2.5MG/ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2023 DISQUALIFIED FINAL	3
BORTEZOMIB BORTEZOMIB	215441 Product 215441/002	SOLUTION · INTRAVENOUS 3.5MG/1.4ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2023 DISQUALIFIED FINAL	3
BOSENTAN TRACLEER	209279 Product 209279/001	TABLET, FOR SUSPENSION · ORAL 32MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	2
BOSUTINIB MONOHYDRATE BOSULIF	203341 Product 203341/001	TABLET · ORAL EQ 100MG BASE FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	4
BOSUTINIB MONOHYDRATE BOSULIF	203341 Product 203341/002	TABLET · ORAL EQ 500MG BASE FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	4
BOSUTINIB MONOHYDRATE BOSULIF	203341 Product 203341/003	TABLET · ORAL EQ 400MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	4
BOSUTINIB MONOHYDRATE BOSULIF	217729 Product 217729/001	CAPSULE · ORAL EQ 50MG BASE FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	4
BOSUTINIB MONOHYDRATE BOSULIF	217729 Product 217729/002	CAPSULE · ORAL EQ 100MG BASE FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	4
BREMELANOTIDE ACETATE VYLEESI (AUTOINJECTOR)	210557 Product 210557/001	SOLUTION · SUBCUTANEOUS EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	4
BRENSOCATIB BRINSUPRI	217673 Product 217673/001	TABLET · ORAL 10MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	14
BRENSOCATIB BRINSUPRI	217673 Product 217673/002	TABLET · ORAL 25MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	14
brentuximab vedotin Adcetris	125388 Product 125388/001	For Injection · Intravenous 50MG Single-Dose Vial FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
BREPOCITINIB TOSYLATE LISRAYA	220106 Product 220106/001	TABLET · ORAL EQ 30MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	3
BREXANOLONE ZULRESSO	211371 Product 211371/001	SOLUTION · INTRAVENOUS 100MG/20ML (5MG/ML) FDA marketing: Discontinued	2025 WITHDRAWN FINAL	8
BREXPIPRAZOLE REXULTI	205422 Product 205422/001	TABLET · ORAL 0.25MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	5
BREXPIPRAZOLE REXULTI	205422 Product 205422/002	TABLET · ORAL 0.5MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	5
BREXPIPRAZOLE REXULTI	205422 Product 205422/003	TABLET · ORAL 1MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	5
BREXPIPRAZOLE REXULTI	205422 Product 205422/004	TABLET · ORAL 2MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	5
BREXPIPRAZOLE REXULTI	205422 Product 205422/005	TABLET · ORAL 3MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	5
BREXPIPRAZOLE REXULTI	205422 Product 205422/006	TABLET · ORAL 4MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	4
BRIGATINIB ALUNBRIG	208772 Product 208772/001	TABLET · ORAL 30MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	4
BRIGATINIB ALUNBRIG	208772 Product 208772/002	TABLET · ORAL 90MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	4
BRIGATINIB ALUNBRIG	208772 Product 208772/003	TABLET · ORAL 180MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	4
BRILLIANT BLUE G TISSUEBLUE	209569 Product 209569/001	SOLUTION · OPHTHALMIC 0.025% FDA marketing: Prescription	2019 EXCLUDED FINAL	0
BRIMONIDINE TARTRATE LUMIFY	208144 Product 208144/001	SOLUTION/DROPS · OPHTHALMIC 0.025% FDA marketing: Over-the-counter	2017 EXCLUDED FINAL	5
BRIMONIDINE TARTRATE LUMIFY PRESERVATIVE FREE	218424 Product 218424/001	SOLUTION/DROPS · OPHTHALMIC 0.025% FDA marketing: Over-the-counter	2024 EXCLUDED FINAL	5
BRIMONIDINE TARTRATE MIRVASO	204708 Product 204708/001	GEL · TOPICAL EQ 0.33% BASE FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	7
BRIMONIDINE TARTRATE; BRINZOLAMIDE SIMBRINZA	204251 Product 204251/001	SUSPENSION/DROPS · OPHTHALMIC 0.2%;1% FDA marketing: Prescription	2016 DEEP_REVIEW FINAL_CHECKING	2
BRIMONIDINE TARTRATE; CARBACHOL YUVEZZI	220142 Product 220142/001	SOLUTION/DROPS · OPHTHALMIC 0.1%;2.75% FDA marketing: Prescription	2030 DEEP_REVIEW FINAL_CHECKING	2
BRINCIDOFOVIR TEMBEXA	214460 Product 214460/001	SUSPENSION · ORAL 10MG/ML FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	1
BRINCIDOFOVIR TEMBEXA	214461 Product 214461/001	TABLET · ORAL 100MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	5
BRIVARACETAM BRIVARACETAM	221301 Product 221301/001	SOLUTION · ORAL 10MG/ML FDA marketing: Prescription	Master only	0
BRIVARACETAM BRIVIACT	205836 Product 205836/001	TABLET · ORAL 10MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	2
BRIVARACETAM BRIVIACT	205836 Product 205836/002	TABLET · ORAL 25MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	2
BRIVARACETAM BRIVIACT	205836 Product 205836/003	TABLET · ORAL 50MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	2
BRIVARACETAM BRIVIACT	205836 Product 205836/004	TABLET · ORAL 75MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	2
BRIVARACETAM BRIVIACT	205836 Product 205836/005	TABLET · ORAL 100MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	2
BRIVARACETAM BRIVIACT	205837 Product 205837/001	SOLUTION · INTRAVENOUS 50MG/5ML (10MG/ML) FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	1
BRIVARACETAM BRIVIACT	205838 Product 205838/001	SOLUTION · ORAL 10MG/ML FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	1
brodalumab Siliq	761032 Product 761032/001	Injection · Subcutaneous 210MG/1.5ML Pre-Filled Syringe FDA marketing: Prescription	2031 CANDIDATE FINAL	0
brolucizumab-dbll Beovu	761125 Product 761125/001	Injection · Intravitreal 6MG/0.05ML Single-Dose Vial FDA marketing: Prescription	2033 CANDIDATE FINAL	0
BROMFENAC SODIUM BROMDAY	021664 Product 021664/002	SOLUTION/DROPS · OPHTHALMIC EQ 0.09% ACID FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	0
BROMFENAC SODIUM BROMSITE	206911 Product 206911/001	SOLUTION/DROPS · OPHTHALMIC EQ 0.075% ACID FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	1
BROMFENAC SODIUM PROLENSA	203168 Product 203168/001	SOLUTION/DROPS · OPHTHALMIC EQ 0.07% ACID FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	2
BUDESONIDE EOHILIA	213976 Product 213976/001	SUSPENSION · ORAL 2MG/10ML FDA marketing: Prescription	2031 DEEP_REVIEW FINAL_CHECKING	12
BUDESONIDE ORTIKOS	211929 Product 211929/001	CAPSULE, DELAYED RELEASE · ORAL 6MG FDA marketing: Discontinued	2023 DISCONTINUED FINAL	2
BUDESONIDE ORTIKOS	211929 Product 211929/002	CAPSULE, DELAYED RELEASE · ORAL 9MG FDA marketing: Discontinued	2023 DISCONTINUED FINAL	2
BUDESONIDE RHINOCORT ALLERGY	020746 Product 020746/003	SPRAY, METERED · NASAL 0.032MG/SPRAY FDA marketing: Over-the-counter	2015 EXCLUDED FINAL	0
BUDESONIDE TARPEYO	215935 Product 215935/001	CAPSULE, DELAYED RELEASE · ORAL 4MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	5
BUDESONIDE UCERIS	203634 Product 203634/001	TABLET, EXTENDED RELEASE · ORAL 9MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	5
BUDESONIDE UCERIS	205613 Product 205613/001	AEROSOL, FOAM · RECTAL 2MG/ACTUATION FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE BREZTRI AEROSPHERE	220290 Product 220290/001	INHALANT · ORAL 160MCG/9MCG/4.8MCG FDA marketing: Prescription	Master only	0
BUDESONIDE; FORMOTEROL FUMARATE SYMBICORT AEROSPHERE	216579 Product 216579/001	AEROSOL, METERED · INHALATION 0.16MG/INH;0.0048MG/INH FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	2
BUDESONIDE; FORMOTEROL FUMARATE SYMBICORT AEROSPHERE	216579 Product 216579/002	AEROSOL, METERED · INHALATION 0.08MG/INH;0.0048MG/INH FDA marketing: Prescription	2029 DEEP_REVIEW FINAL_CHECKING	2
BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE BREZTRI AEROSPHERE	212122 Product 212122/001	AEROSOL, METERED · INHALATION 0.16MG/INH;0.0048MG/INH;0.009MG/INH FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	9
BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE BREZTRI AEROSPHERE	212122 Product 212122/002	AEROSOL, METERED · INHALATION 0.16MG/INH;0.0048MG/INH;0.018MG/INH FDA marketing: Prescription	2029 DEEP_REVIEW FINAL_CHECKING	9
bulevirtide-gmod Hepcludex	761468 Product 761468/001	For Injection · Subcutaneous 8.5MG Single-Dose Vial FDA marketing: Prescription	2038 CANDIDATE FINAL_CHECKING	1
BUMETANIDE ENBUMYST	219500 Product 219500/001	SPRAY · NASAL 0.5MG/SPRAY FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	4
BUPIVACAINE EXPAREL	022496 Product 022496/001	INJECTABLE, LIPOSOMAL · INJECTION 133MG/10ML (13.3MG/ML) FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	23
BUPIVACAINE EXPAREL	022496 Product 022496/002	INJECTABLE, LIPOSOMAL · INJECTION 266MG/20ML (13.3MG/ML) FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	23
BUPIVACAINE POSIMIR	204803 Product 204803/001	SOLUTION · INFILTRATION 660MG/5ML (132MG/ML) FDA marketing: Discontinued	2021 DISCONTINUED FINAL	2
BUPIVACAINE HYDROCHLORIDE XARACOLL	209511 Product 209511/001	IMPLANT · IMPLANTATION 100MG FDA marketing: Discontinued	2026 WITHDRAWN FINAL	2
BUPIVACAINE; MELOXICAM ZYNRELEF KIT	211988 Product 211988/001	SOLUTION, EXTENDED RELEASE · PERIARTICULAR 60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) FDA marketing: Discontinued	2022 DISCONTINUED FINAL	16
BUPIVACAINE; MELOXICAM ZYNRELEF KIT	211988 Product 211988/002	SOLUTION, EXTENDED RELEASE · PERIARTICULAR 200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) FDA marketing: Prescription	2035 DEEP_REVIEW FINAL_CHECKING	16
BUPIVACAINE; MELOXICAM ZYNRELEF KIT	211988 Product 211988/003	SOLUTION, EXTENDED RELEASE · PERIARTICULAR 300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) FDA marketing: Discontinued	2022 DISCONTINUED FINAL	16
BUPIVACAINE; MELOXICAM ZYNRELEF KIT	211988 Product 211988/004	SOLUTION, EXTENDED RELEASE · PERIARTICULAR 400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) FDA marketing: Prescription	2035 DEEP_REVIEW FINAL_CHECKING	16
BUPRENORPHINE BRIXADI	210136 Product 210136/001	SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS 8MG/0.16ML (50MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	8
BUPRENORPHINE BRIXADI	210136 Product 210136/002	SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS 16MG/0.32ML (50MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	8
BUPRENORPHINE BRIXADI	210136 Product 210136/003	SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS 24MG/0.48ML (50MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	8
BUPRENORPHINE BRIXADI	210136 Product 210136/004	SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS 32MG/0.64ML (50MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	8
BUPRENORPHINE BRIXADI	210136 Product 210136/005	SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS 64MG/0.18ML (356MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	8
BUPRENORPHINE BRIXADI	210136 Product 210136/006	SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS 96MG/0.27ML (356MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	8
BUPRENORPHINE BRIXADI	210136 Product 210136/007	SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS 128MG/0.36ML (356MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	8
BUPRENORPHINE BUTRANS	021306 Product 021306/001	FILM, EXTENDED RELEASE · TRANSDERMAL 5MCG/HR FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
BUPRENORPHINE BUTRANS	021306 Product 021306/002	FILM, EXTENDED RELEASE · TRANSDERMAL 10MCG/HR FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
BUPRENORPHINE BUTRANS	021306 Product 021306/003	FILM, EXTENDED RELEASE · TRANSDERMAL 20MCG/HR FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
BUPRENORPHINE BUTRANS	021306 Product 021306/004	FILM, EXTENDED RELEASE · TRANSDERMAL 15MCG/HR FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
BUPRENORPHINE BUTRANS	021306 Product 021306/005	FILM, EXTENDED RELEASE · TRANSDERMAL 7.5MCG/HR FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	0
BUPRENORPHINE SUBLOCADE	209819 Product 209819/001	SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS 100MG/0.5ML (100MG/0.5ML) FDA marketing: Prescription	2020 DEEP_REVIEW FINAL_CHECKING	12
BUPRENORPHINE SUBLOCADE	209819 Product 209819/002	SOLUTION, EXTENDED RELEASE · SUBCUTANEOUS 300MG/1.5ML (200MG/ML) FDA marketing: Prescription	2020 DEEP_REVIEW FINAL_CHECKING	13
BUPRENORPHINE HYDROCHLORIDE BELBUCA	207932 Product 207932/001	FILM · BUCCAL EQ 0.075MG BASE FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	3
BUPRENORPHINE HYDROCHLORIDE BELBUCA	207932 Product 207932/002	FILM · BUCCAL EQ 0.15MG BASE FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	3
BUPRENORPHINE HYDROCHLORIDE BELBUCA	207932 Product 207932/003	FILM · BUCCAL EQ 0.3MG BASE FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	3
BUPRENORPHINE HYDROCHLORIDE BELBUCA	207932 Product 207932/004	FILM · BUCCAL EQ 0.45MG BASE FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	3
BUPRENORPHINE HYDROCHLORIDE BELBUCA	207932 Product 207932/005	FILM · BUCCAL EQ 0.6MG BASE FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	3
BUPRENORPHINE HYDROCHLORIDE BELBUCA	207932 Product 207932/006	FILM · BUCCAL EQ 0.75MG BASE FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	3
BUPRENORPHINE HYDROCHLORIDE BELBUCA	207932 Product 207932/007	FILM · BUCCAL EQ 0.9MG BASE FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	3
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE	221145 Product 221145/001	INJECTABLE · INJECTION EQ 0.3MG BASE/ML FDA marketing: Prescription	Master only	0
BUPRENORPHINE HYDROCHLORIDE PROBUPHINE	204442 Product 204442/001	IMPLANT · IMPLANTATION EQ 80MG BASE/IMPLANT FDA marketing: Discontinued	2020 DISCONTINUED FINAL	1
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE BUNAVAIL	205637 Product 205637/001	FILM · BUCCAL EQ 2.1MG BASE;EQ 0.3MG BASE FDA marketing: Discontinued	2020 DISCONTINUED FINAL	4
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE BUNAVAIL	205637 Product 205637/002	FILM · BUCCAL EQ 4.2MG BASE;EQ 0.7MG BASE FDA marketing: Discontinued	2020 DISCONTINUED FINAL	4
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE BUNAVAIL	205637 Product 205637/003	FILM · BUCCAL EQ 6.3MG BASE;EQ 1MG BASE FDA marketing: Discontinued	2020 DISCONTINUED FINAL	4
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE CASSIPA	208042 Product 208042/001	FILM · SUBLINGUAL EQ 16MG BASE;EQ 4MG BASE FDA marketing: Discontinued	2019 DISQUALIFIED FINAL	0
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE SUBOXONE	022410 Product 022410/001	FILM · BUCCAL, SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	3
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE SUBOXONE	022410 Product 022410/002	FILM · BUCCAL, SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	3
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE SUBOXONE	022410 Product 022410/003	FILM · BUCCAL, SUBLINGUAL EQ 4MG BASE;EQ 1MG BASE FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	3
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE SUBOXONE	022410 Product 022410/004	FILM · BUCCAL, SUBLINGUAL EQ 12MG BASE;EQ 3MG BASE FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	3
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ZUBSOLV	204242 Product 204242/001	TABLET · SUBLINGUAL EQ 1.4MG BASE;EQ 0.36MG BASE FDA marketing: RX	2013 DEEP_REVIEW FINAL	8
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ZUBSOLV	204242 Product 204242/002	TABLET · SUBLINGUAL EQ 5.7MG BASE;EQ 1.4MG BASE FDA marketing: RX	2013 DEEP_REVIEW FINAL	10
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ZUBSOLV	204242 Product 204242/003	TABLET · SUBLINGUAL EQ 8.6MG BASE;EQ 2.1MG BASE FDA marketing: RX	2014 DEEP_REVIEW FINAL	9
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ZUBSOLV	204242 Product 204242/004	TABLET · SUBLINGUAL EQ 11.4MG BASE;EQ 2.9MG BASE FDA marketing: RX	2014 DEEP_REVIEW FINAL	9
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ZUBSOLV	204242 Product 204242/005	TABLET · SUBLINGUAL EQ 2.9MG BASE;EQ 0.71MG BASE FDA marketing: RX	2015 DEEP_REVIEW FINAL	9
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ZUBSOLV	204242 Product 204242/006	TABLET · SUBLINGUAL EQ 0.7MG BASE;EQ 0.18MG BASE FDA marketing: RX	2016 DEEP_REVIEW FINAL	6
BUPROPION HYDROCHLORIDE FORFIVO XL	022497 Product 022497/001	TABLET, EXTENDED RELEASE · ORAL 450MG FDA marketing: Prescription	2011 DEEP_REVIEW FINAL	1
BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE AUVELITY	215430 Product 215430/001	TABLET, EXTENDED RELEASE · ORAL 105MG;45MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL_CHECKING	148
BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE AUVELITY	215430 Product 215430/002	TABLET, EXTENDED RELEASE · ORAL 105MG;30MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL_CHECKING	56
BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE CONTRAVE	200063 Product 200063/001	TABLET, EXTENDED RELEASE · ORAL 90MG;8MG FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	18
burosumab-twza Crysvita	761068 Product 761068/001	Injection · Subcutaneous 10MG/ML Single-Dose Vial FDA marketing: Prescription	2032 CANDIDATE FINAL	0
CABAZITAXEL CABAZITAXEL	207949 Product 207949/001	SOLUTION · INTRAVENOUS 60MG/3ML (20MG/ML) FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	4
CABAZITAXEL CABAZITAXEL	207970 Product 207970/001	SOLUTION · INTRAVENOUS 60MG/6ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	1
CABAZITAXEL JEVTANA KIT	201023 Product 201023/001	SOLUTION · INTRAVENOUS 60MG/1.5ML (40MG/ML) FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	5
CABOTEGRAVIR APRETUDE	215499 Product 215499/001	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 600MG/3ML (200MG/ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	4
CABOTEGRAVIR SODIUM VOCABRIA	212887 Product 212887/001	TABLET · ORAL EQ 30MG BASE FDA marketing: Prescription	2031 CANDIDATE FINAL	2
CABOTEGRAVIR; RILPIVIRINE CABENUVA KIT	212888 Product 212888/001	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 400MG/2ML (200MG/ML);600MG/2ML (300MG/ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
CABOTEGRAVIR; RILPIVIRINE CABENUVA KIT	212888 Product 212888/002	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 600MG/3ML (200MG/ML);900MG/3ML (300MG/ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
CABOZANTINIB LAURYLSULFATE OMCAZIO	220613 Product 220613/001	CAPSULE · ORAL EQ 11.5MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	7
CABOZANTINIB LAURYLSULFATE OMCAZIO	220613 Product 220613/002	CAPSULE · ORAL EQ 23MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	7
CABOZANTINIB LAURYLSULFATE OMCAZIO	220613 Product 220613/003	CAPSULE · ORAL EQ 34.5MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	7
CABOZANTINIB S-MALATE CABOMETYX	208692 Product 208692/001	TABLET · ORAL EQ 20MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	10
CABOZANTINIB S-MALATE CABOMETYX	208692 Product 208692/002	TABLET · ORAL EQ 40MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	10
CABOZANTINIB S-MALATE CABOMETYX	208692 Product 208692/003	TABLET · ORAL EQ 60MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	10
CABOZANTINIB S-MALATE CABOZANTINIB S-MALATE	217870 Product 217870/001	TABLET · ORAL EQ 20MG BASE FDA marketing: Prescription	Master only	0
CABOZANTINIB S-MALATE CABOZANTINIB S-MALATE	217870 Product 217870/002	TABLET · ORAL EQ 40MG BASE FDA marketing: Prescription	Master only	0
CABOZANTINIB S-MALATE CABOZANTINIB S-MALATE	217870 Product 217870/003	TABLET · ORAL EQ 60MG BASE FDA marketing: Prescription	Master only	0
CABOZANTINIB S-MALATE COMETRIQ	203756 Product 203756/001	CAPSULE · ORAL EQ 20MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	8
CABOZANTINIB S-MALATE COMETRIQ	203756 Product 203756/002	CAPSULE · ORAL EQ 80MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	8
calaspargase pegol-mknl Asparlas	761102 Product 761102/001	Injection · Intravenous 3,750UNITS/5ML (750UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	0
CALCIFEDIOL RAYALDEE	208010 Product 208010/001	CAPSULE, EXTENDED RELEASE · ORAL 0.03MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	16
CALCIPOTRIENE SORILUX	022563 Product 022563/001	AEROSOL, FOAM · TOPICAL 0.005% FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	2
CALCIUM ACETATE PHOSLYRA	022581 Product 022581/001	SOLUTION · ORAL 667MG/5ML FDA marketing: Discontinued	2023 DISCONTINUED FINAL	3
CALCIUM CHLORIDE CALREZDY	219456 Product 219456/001	SOLUTION · EXTRACORPOREAL 14.7G/L calcium chloride dihydrate (100MMOL/L calcium) FDA marketing: Prescription	2026 NEW_APPROVAL PROVISIONAL	0
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER	207026 Product 207026/002	INJECTABLE · INJECTION N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) FDA marketing: Prescription	2022 CANDIDATE FINAL	0
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER	207026 Product 207026/001	INJECTABLE · INJECTION 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) FDA marketing: Prescription	2022 CANDIDATE FINAL	0
CALCIUM GLUCONATE CALCIUM GLUCONATE	208418 Product 208418/001	SOLUTION · INTRAVENOUS 1GM/10ML (100MG/ML) FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
CALCIUM GLUCONATE CALCIUM GLUCONATE	208418 Product 208418/002	SOLUTION · INTRAVENOUS 5GM/50ML (100MG/ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
CALCIUM GLUCONATE CALCIUM GLUCONATE	208418 Product 208418/003	SOLUTION · INTRAVENOUS 10GM/100ML (100MG/ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
CALCIUM GLUCONATE CALCIUM GLUCONATE	210906 Product 210906/004	SOLUTION · INTRAVENOUS 10GM/100ML (100MG/ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
CALCIUM GLUCONATE CALCIUM GLUCONATE IN SODIUM CHLORIDE	208418 Product 208418/004	SOLUTION · INTRAVENOUS 1GM/50ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2023 EXISTING_GENERIC DISQUALIFIED	1
CALCIUM GLUCONATE CALCIUM GLUCONATE IN SODIUM CHLORIDE	208418 Product 208418/005	SOLUTION · INTRAVENOUS 2GM/100ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2023 EXISTING_GENERIC DISQUALIFIED	1
CALCIUM GLUCONATE CALCIUM GLUCONATE IN SODIUM CHLORIDE	210906 Product 210906/001	SOLUTION · INTRAVENOUS 1GM/50ML (20MG/ML) FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	2
CALCIUM GLUCONATE CALCIUM GLUCONATE IN SODIUM CHLORIDE	210906 Product 210906/002	SOLUTION · INTRAVENOUS 2GM/100ML (20MG/ML) FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	2
CALCIUM GLUCONATE CALCIUM GLUCONATE IN SODIUM CHLORIDE	210906 Product 210906/003	SOLUTION · INTRAVENOUS 1GM/100ML (10MG/ML) FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	2
CALCIUM GLUCONATE CALCIUM GLUCONATE IN SODIUM CHLORIDE	217891 Product 217891/001	SOLUTION · INTRAVENOUS 1GM/50ML (20MG/ML) FDA marketing: Prescription	Master only	0
CALCIUM GLUCONATE CALCIUM GLUCONATE IN SODIUM CHLORIDE	217891 Product 217891/002	SOLUTION · INTRAVENOUS 2GM/100ML (20MG/ML) FDA marketing: Prescription	Master only	0
CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE XYWAV	212690 Product 212690/001	SOLUTION · ORAL 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML FDA marketing: Prescription	2033 DEEP_REVIEW FINAL_CHECKING	16
CAMIZESTRANT ETCAMAH	220359 Product 220359/001	TABLET · ORAL 75MG FDA marketing: Prescription	2041 CANDIDATE FINAL	6
CANAGLIFLOZIN INVOKANA	204042 Product 204042/001	TABLET · ORAL 100MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	3
CANAGLIFLOZIN INVOKANA	204042 Product 204042/002	TABLET · ORAL 300MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	3
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE INVOKAMET	204353 Product 204353/001	TABLET · ORAL 50MG;500MG FDA marketing: RX	2028 DEEP_REVIEW FINAL	4
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE INVOKAMET	204353 Product 204353/002	TABLET · ORAL 50MG;1GM FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	4
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE INVOKAMET	204353 Product 204353/003	TABLET · ORAL 150MG;500MG FDA marketing: RX	2028 DEEP_REVIEW FINAL	4
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE INVOKAMET	204353 Product 204353/004	TABLET · ORAL 150MG;1GM FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	4
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE INVOKAMET XR	205879 Product 205879/001	TABLET, EXTENDED RELEASE · ORAL 50MG;500MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	3
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE INVOKAMET XR	205879 Product 205879/002	TABLET, EXTENDED RELEASE · ORAL 50MG;1GM FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	3
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE INVOKAMET XR	205879 Product 205879/003	TABLET, EXTENDED RELEASE · ORAL 150MG;500MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	3
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE INVOKAMET XR	205879 Product 205879/004	TABLET, EXTENDED RELEASE · ORAL 150MG;1GM FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	3
CANGRELOR KENGREAL	204958 Product 204958/001	POWDER · INTRAVENOUS 50MG/VIAL FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	7
CANNABIDIOL EPIDIOLEX	210365 Product 210365/001	SOLUTION · ORAL 100MG/ML FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	33
CANTHARIDIN YCANTH	212905 Product 212905/001	SOLUTION · TOPICAL 0.7% FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	4
CAPIVASERTIB TRUQAP	218197 Product 218197/001	TABLET · ORAL 160MG FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	9
CAPIVASERTIB TRUQAP	218197 Product 218197/002	TABLET · ORAL 200MG FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	9
caplacizumab-yhdp Cablivi	761112 Product 761112/001	For injection · Intravenous, Subcutaneous 11MG Single-Dose Vial FDA marketing: Prescription	2032 CANDIDATE FINAL	0
CAPMATINIB HYDROCHLORIDE TABRECTA	213591 Product 213591/001	TABLET · ORAL EQ 150MG BASE FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	7
CAPMATINIB HYDROCHLORIDE TABRECTA	213591 Product 213591/002	TABLET · ORAL EQ 200MG BASE FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	7
CARBAMAZEPINE CARNEXIV	206030 Product 206030/001	SOLUTION · INTRAVENOUS 200MG/20ML (10MG/ML) FDA marketing: Discontinued	2018 DISCONTINUED FINAL	7
CARBIDOPA; LEVODOPA CREXONT	217186 Product 217186/001	CAPSULE, EXTENDED RELEASE · ORAL 35MG;140MG FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	30
CARBIDOPA; LEVODOPA CREXONT	217186 Product 217186/002	CAPSULE, EXTENDED RELEASE · ORAL 52.5MG;210MG FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	30
CARBIDOPA; LEVODOPA CREXONT	217186 Product 217186/003	CAPSULE, EXTENDED RELEASE · ORAL 70MG;280MG FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	30
CARBIDOPA; LEVODOPA CREXONT	217186 Product 217186/004	CAPSULE, EXTENDED RELEASE · ORAL 87.5MG;350MG FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	30
CARBIDOPA; LEVODOPA DHIVY	214869 Product 214869/001	TABLET · ORAL 25MG;100MG FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	3
CARBIDOPA; LEVODOPA DUOPA	203952 Product 203952/001	SUSPENSION · ENTERAL 4.63MG/ML;20MG/ML FDA marketing: Prescription	2022 CANDIDATE FINAL	0
CARBIDOPA; LEVODOPA RYTARY	203312 Product 203312/001	CAPSULE, EXTENDED RELEASE · ORAL 23.75MG;95MG FDA marketing: RX	2018 DEEP_REVIEW FINAL	8
CARBIDOPA; LEVODOPA RYTARY	203312 Product 203312/002	CAPSULE, EXTENDED RELEASE · ORAL 36.25MG;145MG FDA marketing: RX	2018 DEEP_REVIEW FINAL	8
CARBIDOPA; LEVODOPA RYTARY	203312 Product 203312/003	CAPSULE, EXTENDED RELEASE · ORAL 48.75MG;195MG FDA marketing: RX	2018 DEEP_REVIEW FINAL	8
CARBIDOPA; LEVODOPA RYTARY	203312 Product 203312/004	CAPSULE, EXTENDED RELEASE · ORAL 61.25MG;245MG FDA marketing: RX	2018 DEEP_REVIEW FINAL	8
CARBINOXAMINE MALEATE KARBINAL ER	022556 Product 022556/001	SUSPENSION, EXTENDED RELEASE · ORAL 4MG/5ML FDA marketing: Prescription	2013 DEEP_REVIEW FINAL_CHECKING	2
CARBON DIOIDE CARBON DIOXIDE, USP	215007 Product 215007/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
CARBON DIOXIDE CARBON DIOXIDE, USP	205764 Product 205764/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
CARBON DIOXIDE CARBON DIOXIDE, USP	205815 Product 205815/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
CARBON DIOXIDE CARBON DIOXIDE, USP	205846 Product 205846/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
CARBON DIOXIDE CARBON DIOXIDE, USP	205852 Product 205852/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
CARBON DIOXIDE CARBON DIOXIDE, USP	206025 Product 206025/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
CARBON DIOXIDE CARBON DIOXIDE, USP	207166 Product 207166/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
CARBON DIOXIDE CARBON DIOXIDE, USP	210816 Product 210816/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
CARBON DIOXIDE CARBON DIOXIDE, USP	213507 Product 213507/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
CARBON DIOXIDE CARBON DIOXIDE, USP	216614 Product 216614/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
CARBON DIOXIDE CARBON DIOXIDE, USP	217082 Product 217082/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
CARBON DIOXIDE CARBON DIOXIDE, USP	217332 Product 217332/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
CARBON DIOXIDE CARBON DIOXIDE, USP	219303 Product 219303/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
CARBON DIOXIDE CARBON DIOXIDE, USP	219779 Product 219779/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
Carbon Dioxide Carbon Dioxide, USP	220266 Product 220266/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
CARBON DIOXIDE CARBON DIOXIDE, USP	220461 Product 220461/001	GAS · INHALATION	Master only	0
CARBON DIOXIDE CARBON DIOXIDE, USP	220634 Product 220634/001	GAS	Master only	0
CARBON DIOXIDE CARBON DIOXIDE, USP	221021 Product 221021/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
Carbon Dioxide, USP Carbon Dioxide, USP	220050 Product 220050/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
CARBON DIOXIDE, USP CARBON DIOXIDE, USP	222000 Product 222000/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
CARBOPLATIN KYXATA	219921 Product 219921/001	SOLUTION · INTRAVENOUS 20MG/2ML (10MG/ML) FDA marketing: Discontinued	2025 DISCONTINUED FINAL	1
CARBOPLATIN KYXATA	219921 Product 219921/002	SOLUTION · INTRAVENOUS 80MG/8ML (10MG/ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	1
CARBOPLATIN KYXATA	219921 Product 219921/003	SOLUTION · INTRAVENOUS 500MG/50ML (10MG/ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	1
CARDENE IV IN DEXTROSE CARDENE IV IN DEXTROSE	019734 Product 019734/002	— 20MG/200ML	2008 DEEP_REVIEW DEEP_REVIEW	6
CARDENE IV IN DEXTROSE CARDENE IV IN DEXTROSE	019734 Product 019734/005	— 40MG/200ML	2008 DEEP_REVIEW DEEP_REVIEW	4
CARFILZOMIB KYPROLIS	202714 Product 202714/001	POWDER · INTRAVENOUS 60MG/VIAL FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	5
CARFILZOMIB KYPROLIS	202714 Product 202714/002	POWDER · INTRAVENOUS 30MG/VIAL FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	5
CARFILZOMIB KYPROLIS	202714 Product 202714/003	POWDER · INTRAVENOUS 10MG/VIAL FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	5
CARGLUMIC ACID CARBAGLU	022562 Product 022562/001	TABLET, FOR SUSPENSION · ORAL 200MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
CARIPRAZINE HYDROCHLORIDE VRAYLAR	204370 Product 204370/001	CAPSULE · ORAL EQ 1.5MG BASE FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	5
CARIPRAZINE HYDROCHLORIDE VRAYLAR	204370 Product 204370/002	CAPSULE · ORAL EQ 3MG BASE FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	4
CARIPRAZINE HYDROCHLORIDE VRAYLAR	204370 Product 204370/003	CAPSULE · ORAL EQ 4.5MG BASE FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	4
CARIPRAZINE HYDROCHLORIDE VRAYLAR	204370 Product 204370/004	CAPSULE · ORAL EQ 6MG BASE FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	4
CARIPRAZINE HYDROCHLORIDE VRAYLAR	204370 Product 204370/005	CAPSULE · ORAL EQ 0.5MG BASE FDA marketing: Prescription	2030 CANDIDATE FINAL	4
CARIPRAZINE HYDROCHLORIDE VRAYLAR	204370 Product 204370/006	CAPSULE · ORAL EQ 0.75MG BASE FDA marketing: Prescription	2030 CANDIDATE FINAL	4
CARMUSTINE CARMUSTINE	215000 Product 215000/001	POWDER · INTRAVENOUS 50MG/VIAL FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	0
CARMUSTINE CARMUSTINE	215000 Product 215000/002	POWDER · INTRAVENOUS 300MG/VIAL FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	0
CASIMERSEN AMONDYS 45	213026 Product 213026/001	SOLUTION · INTRAVENOUS 100MG/2ML (50MG/ML) FDA marketing: Prescription	2030 CANDIDATE FINAL	5
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE	206110 Product 206110/001	POWDER · INTRAVENOUS 50MG/VIAL FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	1
CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE	206110 Product 206110/002	POWDER · INTRAVENOUS 70MG/VIAL FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	1
CEDAZURIDINE; DECITABINE INQOVI	212576 Product 212576/001	TABLET · ORAL 100MG;35MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	7
CEFAZOLIN SODIUM CEFAZOLIN AND DEXTROSE	050779 Product 050779/003	INJECTABLE · INJECTION EQ 2GM BASE/VIAL FDA marketing: Prescription	2012 DEEP_REVIEW FINAL	0
CEFAZOLIN SODIUM CEFAZOLIN AND DEXTROSE	050779 Product 050779/004	INJECTABLE · INJECTION EQ 3GM BASE/VIAL FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
CEFAZOLIN SODIUM CEFAZOLIN IN DEXTROSE	207131 Product 207131/001	SOLUTION · INTRAVENOUS EQ 2GM BASE/100ML (EQ 20MG BASE/ML) FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	0
CEFAZOLIN SODIUM CEFAZOLIN IN DEXTROSE	207131 Product 207131/002	SOLUTION · INTRAVENOUS EQ 1GM BASE/50ML (EQ 20MG BASE/ML) FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	0
CEFAZOLIN SODIUM CEFAZOLIN IN DEXTROSE	207131 Product 207131/003	SOLUTION · INTRAVENOUS EQ 3GM BASE/150ML (EQ 20MG BASE/ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
CEFAZOLIN SODIUM CEFAZOLIN SODIUM	211413 Product 211413/001	POWDER · INTRAVENOUS EQ 2GM BASE/VIAL FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
CEFAZOLIN SODIUM CEFAZOLIN SODIUM	211413 Product 211413/002	POWDER · INTRAVENOUS EQ 3GM BASE/VIAL FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
CEFAZOLIN SODIUM CEFAZOLIN SODIUM	216109 Product 216109/001	POWDER · INTRAVENOUS EQ 2GM BASE/VIAL FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
CEFAZOLIN SODIUM CEFAZOLIN SODIUM	216109 Product 216109/002	POWDER · INTRAVENOUS EQ 3GM BASE/VIAL FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
CEFEPIME HYDROCHLORIDE CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	050821 Product 050821/001	INJECTABLE · INJECTION EQ 1GM BASE/VIAL FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
CEFEPIME HYDROCHLORIDE CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	050821 Product 050821/002	INJECTABLE · INJECTION EQ 2GM BASE/VIAL FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM EXBLIFEP	216165 Product 216165/001	POWDER · INTRAVENOUS EQ 2GM BASE/VIAL;0.5GM/VIAL FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	2
CEFEPIME HYDROCHLORIDE; ZIDEBACTAM ZAYNICH	220787 Product 220787/001	POWDER · INTRAVENOUS EQ 2GM BASE/VIAL;1GM/VIAL FDA marketing: Prescription	2036 CANDIDATE FINAL	7
CEFIDEROCOL SULFATE TOSYLATE FETROJA	209445 Product 209445/001	POWDER · INTRAVENOUS EQ 1GM BASE/VIAL FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	3
CEFIXIME SUPRAX	202091 Product 202091/001	FOR SUSPENSION · ORAL 500MG/5ML FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	1
CEFIXIME SUPRAX	203195 Product 203195/001	CAPSULE · ORAL 400MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
CEFTAROLINE FOSAMIL TEFLARO	200327 Product 200327/001	POWDER · INTRAVENOUS 400MG/VIAL FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	2
CEFTAROLINE FOSAMIL TEFLARO	200327 Product 200327/002	POWDER · INTRAVENOUS 600MG/VIAL FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	2
CEFTAZIDIME CEFTAZIDIME IN DEXTROSE CONTAINER	050823 Product 050823/001	INJECTABLE · INJECTION EQ 1GM BASE FDA marketing: Discontinued	2023 DISCONTINUED FINAL	0
CEFTAZIDIME CEFTAZIDIME IN DEXTROSE CONTAINER	050823 Product 050823/002	INJECTABLE · INJECTION EQ 2GM BASE FDA marketing: Discontinued	2023 DISCONTINUED FINAL	0
CEFTOBIPROLE MEDOCARIL SODIUM ZEVTERA	218275 Product 218275/001	POWDER · INTRAVENOUS 667MG/VIAL FDA marketing: Prescription	2034 CANDIDATE FINAL	0
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM ZERBAXA	206829 Product 206829/001	POWDER · INTRAVENOUS EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	12
CELECOXIB ELYXYB	212157 Product 212157/001	SOLUTION · ORAL 25MG/ML FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	6
CELECOXIB VYSCOXA	211759 Product 211759/001	SUSPENSION · ORAL 10MG/ML FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	1
CELECOXIB; TRAMADOL HYDROCHLORIDE SEGLENTIS	213426 Product 213426/001	TABLET · ORAL 56MG;44MG FDA marketing: DISCONTINUED	2024 DISQUALIFIED FINAL	7
cemiplimab-rwlc Libtayo	761097 Product 761097/001	Injection · Intravenous 350MG/7ML (50MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	0
cenegermin-bkbj Oxervate	761094 Product 761094/001	Solution · Topical 0.002% (20MCG/ML) Multi-Dose Vial FDA marketing: Prescription	2030 CANDIDATE FINAL	0
CENOBAMATE XCOPRI	212839 Product 212839/001	TABLET · ORAL 12.5MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	2
CENOBAMATE XCOPRI	212839 Product 212839/002	TABLET · ORAL 25MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	2
CENOBAMATE XCOPRI	212839 Product 212839/003	TABLET · ORAL 50MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	2
CENOBAMATE XCOPRI	212839 Product 212839/004	TABLET · ORAL 100MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	2
CENOBAMATE XCOPRI	212839 Product 212839/005	TABLET · ORAL 150MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	2
CENOBAMATE XCOPRI	212839 Product 212839/006	TABLET · ORAL 200MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	2
CENTANAFADINE HYDROCHLORIDE SIMTRIYO	218145 Product 218145/001	CAPSULE, EXTENDED RELEASE 280MG FDA marketing: Prescription	Master only	0
CERITINIB ZYKADIA	205755 Product 205755/001	CAPSULE · ORAL 150MG FDA marketing: DISCONTINUED	2019 DISQUALIFIED FINAL	7
CERITINIB ZYKADIA	211225 Product 211225/001	TABLET · ORAL 150MG FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	8
cerliponase alfa Brineura	761052 Product 761052/001	Injection · Intraventricular 150MG/5ML (30MG/ML) Single-Dose Vial FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	0
CETIRIZINE HYDROCHLORIDE CHILDREN'S ZYRTEC ALLERGY	021621 Product 021621/007	TABLET, CHEWABLE · ORAL 2.5MG FDA marketing: Over-the-counter	2020 EXCLUDED FINAL	0
CETIRIZINE HYDROCHLORIDE QUZYTTIR	211415 Product 211415/001	SOLUTION · INTRAVENOUS 10MG/ML (10MG/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	5
CETIRIZINE HYDROCHLORIDE ZERVIATE	208694 Product 208694/001	SOLUTION/DROPS · OPHTHALMIC EQ 0.24% BASE FDA marketing: Prescription	2020 DEEP_REVIEW FINAL_CHECKING	4
CETIRIZINE HYDROCHLORIDE ZYRTEC ALLERGY	022578 Product 022578/001	TABLET, ORALLY DISINTEGRATING · ORAL 10MG FDA marketing: Over-the-counter	2010 EXCLUDED FINAL	0
CHENODIOL CTEXLI	219488 Product 219488/001	TABLET · ORAL 250MG FDA marketing: Prescription	2032 CANDIDATE FINAL	0
CHLORAPREP ONE-STEP CHLORAPREP ONE-STEP	020832 Product 020832/001	— 3ML	2000 EXCLUDED FINAL	0
CHLORAPREP ONE-STEP CHLORAPREP ONE-STEP	020832 Product 020832/003	— 1.5ML (FREPP)	2002 EXCLUDED FINAL	0
CHLORAPREP ONE-STEP CHLORAPREP ONE-STEP	020832 Product 020832/004	— 10.5ML	2003 EXCLUDED FINAL	0
CHLORAPREP ONE-STEP CHLORAPREP ONE-STEP	020832 Product 020832/006	— 26ML	2006 EXCLUDED FINAL	0
CHLORAPREP ONE-STEP CHLORAPREP ONE-STEP	020832 Product 020832/008	— 1ML	2008 EXCLUDED FINAL	0
CHLORHEXIDINE GLUCONATE READYPREP CHG	207964 Product 207964/001	CLOTH · TOPICAL 2% FDA marketing: Over-the-counter	2018 EXCLUDED FINAL	0
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL SOLUPREP S	208288 Product 208288/001	SOLUTION · TOPICAL 2%;70% FDA marketing: Over-the-counter	2018 EXCLUDED FINAL	0
CHLOROPROCAINE HYDROCHLORIDE CLOROTEKAL	208791 Product 208791/001	SOLUTION · INTRATHECAL 50MG/5ML (10MG/ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	2
CHLOROPROCAINE HYDROCHLORIDE IHEEZO	216227 Product 216227/001	GEL · OPHTHALMIC 3% FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	2
CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE TUXARIN ER	206323 Product 206323/001	TABLET, EXTENDED RELEASE · ORAL 8MG;54.3MG FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	2
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE VITUZ	204307 Product 204307/001	SOLUTION · ORAL 4MG/5ML;5MG/5ML FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	0
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE ZUTRIPRO	022439 Product 022439/001	SOLUTION · ORAL 4MG/5ML;5MG/5ML;60MG/5ML FDA marketing: Discontinued	2023 WITHDRAWN FINAL	0
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE ADVIL ALLERGY AND CONGESTION RELIEF	022113 Product 022113/001	TABLET · ORAL 4MG;200MG;10MG FDA marketing: Over-the-counter	2011 EXCLUDED FINAL	0
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE ADVIL MULTI-SYMPTOM COLD & FLU	022113 Product 022113/002	TABLET · ORAL 4MG;200MG;10MG FDA marketing: Over-the-counter	2017 EXCLUDED FINAL	0
CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX TUZISTRA XR	207768 Product 207768/001	SUSPENSION, EXTENDED RELEASE · ORAL EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML FDA marketing: Discontinued	2015 DEEP_REVIEW FINAL_CHECKING	2
CHLORTHALIDONE HEMICLOR	218647 Product 218647/001	TABLET · ORAL 12.5MG FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	1
CHOLIC ACID CHOLBAM	205750 Product 205750/001	CAPSULE · ORAL 50MG FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	0
CHOLIC ACID CHOLBAM	205750 Product 205750/002	CAPSULE · ORAL 250MG FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	0
CHOLINE C-11 CHOLINE C-11	203155 Product 203155/001	INJECTABLE · INTRAVENOUS 4-33.1mCi/ML FDA marketing: Prescription	2012 EXCLUDED FINAL	0
CICLESONIDE ZETONNA	202129 Product 202129/001	AEROSOL, METERED · NASAL 0.037MG/INH FDA marketing: Discontinued	2024 DISCONTINUED FINAL	1
CILASTATIN SODIUM; IMIPENEM; RELEBACTAM RECARBRIO	212819 Product 212819/001	POWDER · INTRAVENOUS EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL FDA marketing: DISCONTINUED	2026 DISQUALIFIED FINAL	1
cipaglucosidase alfa-atga Pombiliti	761204 Product 761204/001	Injection · Intravenous 105MG Single-Dose Vial FDA marketing: Prescription	2035 DEEP_REVIEW FINAL_CHECKING	1
CIPEPOFOL CYPSEDO	220482 Product 220482/001	EMULSION · INTRAVENOUS 50MG/20ML (2.5MG/ML) FDA marketing: Prescription	2034 CANDIDATE FINAL	2
CIPROFLOXACIN OTIPRIO	207986 Product 207986/001	INJECTABLE, SUSPENSION · OTIC 6% (60MG/ML) FDA marketing: DISCONTINUED	2023 DISQUALIFIED FINAL	8
CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE OTOVEL	208251 Product 208251/001	SOLUTION/DROPS · OTIC EQ 0.3% BASE;0.025% FDA marketing: Prescription	2019 DEEP_REVIEW FINAL_CHECKING	1
CIPROFLOXACIN; DEXAMETHASONE CIPROFLOXACIN AND DEXAMETHASONE	217723 Product 217723/001	SUSPENSION/DROPS · OTIC 0.3%;0.1% FDA marketing: Prescription	Master only	0
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE	215428 Product 215428/001	CAPSULE · ORAL EQ 30MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	0
CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE PHEXX	208352 Product 208352/001	GEL · VAGINAL 1%;1.8%;0.4% FDA marketing: Prescription	Master only	4
CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE CLENPIQ	209589 Product 209589/001	SOLUTION · ORAL 12GM/BOT;3.5GM/BOT;10MG/BOT FDA marketing: Prescription	2017 DEEP_REVIEW FINAL_CHECKING	5
CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE PREPOPIK	202535 Product 202535/001	FOR SOLUTION · ORAL 12GM/PACKET;3.5GM/PACKET;10MG/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2015 DEEP_REVIEW FINAL_CHECKING	2
CLADRIBINE MAVENCLAD	022561 Product 022561/001	TABLET · ORAL 10MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	3
CLASCOTERONE WINLEVI	213433 Product 213433/001	CREAM · TOPICAL 1% FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	8
clesrovimab-cfor Enflonsia	761432 Product 761432/001	Injection · Intramuscular 105MG/0.7ML Pre-Filled Syringe FDA marketing: Prescription	2037 DEEP_REVIEW FINAL_CHECKING	5
CLEVIDIPINE CLEVIPREX	022156 Product 022156/003	EMULSION · INTRAVENOUS 125MG/250ML (0.5MG/ML) FDA marketing: Discontinued	2021 DEEP_REVIEW FINAL_CHECKING	3
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	208083 Product 208083/001	SOLUTION · INTRAVENOUS EQ 300MG BASE/50ML (EQ 6MG BASE/ML) FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	0
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	208083 Product 208083/002	SOLUTION · INTRAVENOUS EQ 600MG BASE/50ML (EQ 12MG BASE/ML) FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	0
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	208083 Product 208083/003	SOLUTION · INTRAVENOUS EQ 900MG BASE/50ML (EQ 18MG BASE/ML) FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	0
CLINDAMYCIN PHOSPHATE XACIATO	215650 Product 215650/001	GEL · VAGINAL EQ 2% BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL_CHECKING	2
CLINDAMYCIN PHOSPHATE; TRETINOIN VELTIN	050803 Product 050803/001	GEL · TOPICAL 1.2%;0.025% FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
CLOBAZAM ONFI	202067 Product 202067/001	TABLET · ORAL 5MG FDA marketing: Discontinued	2012 DISCONTINUED FINAL	0
CLOBAZAM ONFI	202067 Product 202067/002	TABLET · ORAL 10MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
CLOBAZAM ONFI	202067 Product 202067/003	TABLET · ORAL 20MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
CLOBAZAM ONFI	203993 Product 203993/001	SUSPENSION · ORAL 2.5MG/ML FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
CLOBAZAM SYMPAZAN	210833 Product 210833/001	FILM · ORAL 5MG FDA marketing: Prescription	2018 DEEP_REVIEW FINAL_CHECKING	3
CLOBAZAM SYMPAZAN	210833 Product 210833/002	FILM · ORAL 10MG FDA marketing: Prescription	2018 DEEP_REVIEW FINAL_CHECKING	3
CLOBAZAM SYMPAZAN	210833 Product 210833/003	FILM · ORAL 20MG FDA marketing: Prescription	2018 DEEP_REVIEW FINAL_CHECKING	1
CLOBETASOL PROPIONATE BYQLOVI	218158 Product 218158/001	SUSPENSION/DROPS · OPHTHALMIC 0.05% FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	2
CLOBETASOL PROPIONATE IMPEKLO	213691 Product 213691/001	LOTION · TOPICAL 0.05% FDA marketing: Discontinued	DISCONTINUED FINAL	0
CLOBETASOL PROPIONATE IMPOYZ	209483 Product 209483/001	CREAM · TOPICAL 0.025% FDA marketing: Prescription	2020 DEEP_REVIEW FINAL_CHECKING	5
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE	091368 Product 091368/004	TABLET · ORAL 0.05MG FDA marketing: Prescription	Master only	0
CLONIDINE HYDROCHLORIDE JAVADIN	220256 Product 220256/001	SOLUTION · ORAL 0.02MG/ML FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	3
CLONIDINE HYDROCHLORIDE JENLOGA	022331 Product 022331/002	TABLET, EXTENDED RELEASE · ORAL 0.2MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	1
CLONIDINE HYDROCHLORIDE KAPVAY	022331 Product 022331/003	TABLET, EXTENDED RELEASE · ORAL 0.1MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	1
CLONIDINE HYDROCHLORIDE KAPVAY	022331 Product 022331/004	TABLET, EXTENDED RELEASE · ORAL 0.2MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	1
CLONIDINE HYDROCHLORIDE ONYDA XR	217645 Product 217645/001	SUSPENSION, EXTENDED RELEASE · ORAL 0.1MG/ML FDA marketing: Prescription	2024 DEEP_REVIEW FINAL_CHECKING	3
CLONIDINE HYDROCHLORIDE QLONILIK	221094 Product 221094/001	SOLUTION · ORAL 0.05MG/ML FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	1
CLOTRIMAZOLE CLOTIC	217628 Product 217628/001	SOLUTION/DROPS · OTIC 1% FDA marketing: Prescription	2037 DEEP_REVIEW FINAL_CHECKING	1
CLOZAPINE CLOZARIL	019758 Product 019758/003	TABLET · ORAL 50MG FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	0
CLOZAPINE CLOZARIL	019758 Product 019758/004	TABLET · ORAL 200MG FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	0
CLOZAPINE FAZACLO ODT	021590 Product 021590/005	TABLET, ORALLY DISINTEGRATING · ORAL 150MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	3
CLOZAPINE FAZACLO ODT	021590 Product 021590/006	TABLET, ORALLY DISINTEGRATING · ORAL 200MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	3
CLOZAPINE VERSACLOZ	203479 Product 203479/001	SUSPENSION · ORAL 50MG/ML FDA marketing: Prescription	2013 DEEP_REVIEW FINAL_CHECKING	1
COBICISTAT TYBOST	203094 Product 203094/001	TABLET · ORAL 150MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	2
COBICISTAT TYBOST	203094 Product 203094/002	TABLET · ORAL 90MG FDA marketing: Discontinued	2025 DISQUALIFIED FINAL	2
COBICISTAT; DARUNAVIR ETHANOLATE PREZCOBIX	205395 Product 205395/001	TABLET · ORAL 150MG;EQ 800MG BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	3
COBICISTAT; DARUNAVIR ETHANOLATE PREZCOBIX	205395 Product 205395/002	TABLET · ORAL 150MG;EQ 675MG BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	3
COBICISTAT; DARUNAVIR ETHANOLATE PREZCOBIX PED	220092 Product 220092/001	TABLET, FOR SUSPENSION · ORAL 90MG;EQ 600MG BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	2
COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE SYMTUZA	210455 Product 210455/001	TABLET · ORAL 150MG;800MG;200MG;EQ 10MG BASE FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	6
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GENVOYA	207561 Product 207561/001	TABLET · ORAL 150MG;150MG;200MG;EQ 10MG BASE FDA marketing: Prescription	2033 CANDIDATE FINAL	9
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE STRIBILD	203100 Product 203100/001	TABLET · ORAL 150MG;150MG;200MG;300MG FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	7
COBIMETINIB FUMARATE COTELLIC	206192 Product 206192/001	TABLET · ORAL EQ 20MG BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	7
COCAINE HYDROCHLORIDE GOPRELTO	209963 Product 209963/001	SOLUTION · NASAL 4% FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	12
COCAINE HYDROCHLORIDE NUMBRINO	209575 Product 209575/001	SOLUTION · NASAL 4% FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	11
CODEINE SULFATE CODEINE SULFATE	202245 Product 202245/001	SOLUTION · ORAL 30MG/5ML FDA marketing: Discontinued	2015 DISCONTINUED FINAL	0
COLCHICINE GLOPERBA	210942 Product 210942/001	SOLUTION · ORAL 0.6MG/5ML FDA marketing: Prescription	2019 DEEP_REVIEW FINAL_CHECKING	6
COLCHICINE LODOCO	215727 Product 215727/001	TABLET · ORAL 0.5MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	13
COLCHICINE MITIGARE	204820 Product 204820/001	CAPSULE · ORAL 0.6MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	5
COLESEVELAM HYDROCHLORIDE WELCHOL	210895 Product 210895/001	BAR, CHEWABLE · ORAL 3.75GM FDA marketing: Discontinued	2020 DISQUALIFIED FINAL	1
collagenase clostridium histolyticum Xiaflex	125338 Product 125338/001	For Injection · Intralesional 0.9MG Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
collagenase clostridium histolyticum-aaes Qwo	761146 Product 761146/001	For Injection · Subcutaneous .92MG Single-Dose Vial FDA marketing: Prescription	WITHDRAWN FINAL	0
collagenase clostridium histolyticum-aaes Qwo	761146 Product 761146/002	For Injection · Subcutaneous 1.84MG Single-Dose Vial FDA marketing: Prescription	WITHDRAWN FINAL	0
concizumab-mtci Alhemo	761315 Product 761315/001	Injection · Subcutaneous 60MG/1.5ML (40MG/ML) Autoinjector FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	1
concizumab-mtci Alhemo	761315 Product 761315/002	Injection · Subcutaneous 150MG/1.5ML (100MG/ML) Autoinjector FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	1
concizumab-mtci Alhemo	761315 Product 761315/003	Injection · Subcutaneous 300MG/3ML (100MG/ML) Autoinjector FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	1
COPANLISIB DIHYDROCHLORIDE ALIQOPA	209936 Product 209936/001	POWDER · INTRAVENOUS 60MG/VIAL FDA marketing: Discontinued	Master only	3
COPPER MIUDELLA	218201 Product 218201/001	SYSTEM · INTRAUTERINE N/A FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	14
COPPER CU-64 DOTATATE DETECTNET	213227 Product 213227/001	SOLUTION · INTRAVENOUS 4mL (1mCi/ML) FDA marketing: Prescription	2020 EXCLUDED FINAL	4
COPPER HISTIDINATE ZYCUBO	211241 Product 211241/001	POWDER · SUBCUTANEOUS 2.9MG/VIAL FDA marketing: Prescription	2033 CANDIDATE FINAL	0
CORTICOTROPIN ACTHAR GEL (AUTOINJECTOR)	008372 Product 008372/003	INJECTABLE · INJECTION 40 UNITS/0.5ML FDA marketing: Prescription	2024 EXCLUDED FINAL	1
CORTICOTROPIN ACTHAR GEL (AUTOINJECTOR)	008372 Product 008372/004	INJECTABLE · INJECTION 80 UNITS/ML FDA marketing: Prescription	2024 EXCLUDED FINAL	1
cosibelimab-ipdl Unloxcyt	761297 Product 761297/001	Injection · Intravenous 300MG/5ML (60MG/ML) Single-Dose Vial FDA marketing: Prescription	2038 DEEP_REVIEW FINAL_CHECKING	2
CRINECERFONT CRENESSITY	218808 Product 218808/001	CAPSULE · ORAL 25MG FDA marketing: Prescription	2041 DEEP_REVIEW FINAL	5
CRINECERFONT CRENESSITY	218808 Product 218808/002	CAPSULE · ORAL 50MG FDA marketing: Prescription	2041 DEEP_REVIEW FINAL	5
CRINECERFONT CRENESSITY	218808 Product 218808/003	CAPSULE · ORAL 100MG FDA marketing: Prescription	2041 DEEP_REVIEW FINAL	5
CRINECERFONT CRENESSITY	218820 Product 218820/001	SOLUTION · ORAL 50MG/ML FDA marketing: Prescription	2041 DEEP_REVIEW FINAL	5
CRISABOROLE CRISABOROLE	216242 Product 216242/001	OINTMENT · TOPICAL 2% FDA marketing: Prescription	Master only	0
CRISABOROLE EUCRISA	207695 Product 207695/001	OINTMENT · TOPICAL 2% FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	4
crizanlizumab-tmca Adakveo	761128 Product 761128/001	Injection · Intravenous 100MG/10ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2031 CANDIDATE FINAL	0
CRIZOTINIB XALKORI	202570 Product 202570/001	CAPSULE · ORAL 200MG FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	3
CRIZOTINIB XALKORI	202570 Product 202570/002	CAPSULE · ORAL 250MG FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	3
CRIZOTINIB XALKORI	217581 Product 217581/001	CAPSULE, PELLETS · ORAL 20MG FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	3
CRIZOTINIB XALKORI	217581 Product 217581/002	CAPSULE, PELLETS · ORAL 50MG FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	3
CRIZOTINIB XALKORI	217581 Product 217581/003	CAPSULE, PELLETS · ORAL 150MG FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	3
CROFELEMER MYTESI	202292 Product 202292/001	TABLET, DELAYED RELEASE · ORAL 125MG FDA marketing: Prescription	2031 CANDIDATE FINAL	2
crovalimab-akkz Piasky	761388 Product 761388/001	Injection · Intravenous, Subcutaneous 340MG/2ML (170MG/ML) Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	1
CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE MULTRYS	209376 Product 209376/003	SOLUTION · INTRAVENOUS EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL_CHECKING	5
CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE TRALEMENT	209376 Product 209376/001	SOLUTION · INTRAVENOUS EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL_CHECKING	5
CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE TRALEMENT	209376 Product 209376/002	SOLUTION · INTRAVENOUS EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL_CHECKING	5
CYCLOBENZAPRINE HYDROCHLORIDE TONMYA	219428 Product 219428/001	TABLET · SUBLINGUAL 2.8MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	4
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE	203856 Product 203856/001	CAPSULE · ORAL 25MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE	203856 Product 203856/002	CAPSULE · ORAL 50MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE	210735 Product 210735/001	SOLUTION · INTRAVENOUS 500MG/2.5ML (200MG/ML) FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	1
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE	210735 Product 210735/002	SOLUTION · INTRAVENOUS 1GM/5ML (200MG/ML) FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	1
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE	210735 Product 210735/003	SOLUTION · INTRAVENOUS 2GM/10ML (200MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE	212501 Product 212501/001	SOLUTION · INTRAVENOUS 500MG/2.5ML (200MG/ML) FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	2
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE	212501 Product 212501/002	SOLUTION · INTRAVENOUS 1GM/5ML (200MG/ML) FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	2
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE	212501 Product 212501/003	SOLUTION · INTRAVENOUS 2GM/10ML (200MG/ML) FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	2
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE	217150 Product 217150/001	SOLUTION · INTRAVENOUS 500MG/5ML (100MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE	217150 Product 217150/002	SOLUTION · INTRAVENOUS 1GM/10ML (100MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE	217150 Product 217150/003	SOLUTION · INTRAVENOUS 2GM/20ML (100MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE	217651 Product 217651/001	SOLUTION · INTRAVENOUS 500MG/2.5ML (200MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE	217651 Product 217651/002	SOLUTION · INTRAVENOUS 1GM/5ML (200MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
CYCLOPHOSPHAMIDE FRINDOVYX	210852 Product 210852/001	SOLUTION · INTRAVENOUS 500MG/ML (500MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	2
CYCLOPHOSPHAMIDE FRINDOVYX	210852 Product 210852/002	SOLUTION · INTRAVENOUS 1GM/2ML (500MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	2
CYCLOPHOSPHAMIDE FRINDOVYX	210852 Product 210852/003	SOLUTION · INTRAVENOUS 2GM/4ML (500MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	2
CYCLOSPORINE CEQUA	210913 Product 210913/001	SOLUTION · OPHTHALMIC 0.09% FDA marketing: Prescription	2018 DEEP_REVIEW FINAL_CHECKING	5
CYCLOSPORINE CYCLOSPORINE	219652 Product 219652/001	CAPSULE · ORAL 25MG FDA marketing: Prescription	Master only	0
CYCLOSPORINE CYCLOSPORINE	219652 Product 219652/002	CAPSULE · ORAL 50MG FDA marketing: Prescription	Master only	0
CYCLOSPORINE CYCLOSPORINE	219652 Product 219652/003	CAPSULE · ORAL 100MG FDA marketing: Prescription	Master only	0
CYCLOSPORINE RESTASIS MULTIDOSE	050790 Product 050790/002	EMULSION · OPHTHALMIC 0.05% FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	4
CYCLOSPORINE VERKAZIA	214965 Product 214965/001	EMULSION · OPHTHALMIC 0.1% FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	7
CYCLOSPORINE VEVYE	217469 Product 217469/001	SOLUTION · OPHTHALMIC 0.1% FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	5
CYPROHEPTADINE HYDROCHLORIDE CYPROLARA	212491 Product 212491/002	TABLET · ORAL 2MG FDA marketing: Prescription	Master only	0
CYSTEAMINE BITARTRATE PROCYSBI	203389 Product 203389/001	CAPSULE, DELAYED RELEASE · ORAL EQ 25MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	12
CYSTEAMINE BITARTRATE PROCYSBI	203389 Product 203389/002	CAPSULE, DELAYED RELEASE · ORAL EQ 75MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	12
CYSTEAMINE BITARTRATE PROCYSBI	213491 Product 213491/001	GRANULE, DELAYED RELEASE · ORAL EQ 75MG BASE/PACKET FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	12
CYSTEAMINE BITARTRATE PROCYSBI	213491 Product 213491/002	GRANULE, DELAYED RELEASE · ORAL EQ 300MG BASE/PACKET FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	12
CYSTEAMINE HYDROCHLORIDE CYSTADROPS	211302 Product 211302/001	SOLUTION/DROPS · OPHTHALMIC EQ 0.37% BASE FDA marketing: Prescription	2023 CANDIDATE FINAL	0
CYSTEAMINE HYDROCHLORIDE CYSTARAN	200740 Product 200740/001	SOLUTION/DROPS · OPHTHALMIC EQ 0.44% BASE FDA marketing: Prescription	2019 CANDIDATE FINAL	0
CYSTEINE HYDROCHLORIDE ELCYS	210660 Product 210660/001	SOLUTION · INTRAVENOUS 500MG/10ML (50MG/ML) FDA marketing: RX	2019 DEEP_REVIEW FINAL	16
CYSTEINE HYDROCHLORIDE ELCYS	210660 Product 210660/002	SOLUTION · INTRAVENOUS 2500MG/50ML (50MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
CYSTEINE HYDROCHLORIDE NOURESS	212535 Product 212535/001	SOLUTION · INTRAVENOUS 500MG/10ML (50MG/ML) FDA marketing: DISCONTINUED	2020 DISCONTINUED FINAL	20
CYTARABINE; DAUNORUBICIN VYXEOS	209401 Product 209401/001	POWDER · INTRAVENOUS 100MG;44MG FDA marketing: Prescription	2024 DEEP_REVIEW FINAL_CHECKING	8
DABIGATRAN ETEXILATE MESYLATE PRADAXA	022512 Product 022512/001	CAPSULE · ORAL EQ 75MG BASE FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	2
DABIGATRAN ETEXILATE MESYLATE PRADAXA	022512 Product 022512/002	CAPSULE · ORAL EQ 150MG BASE FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	2
DABIGATRAN ETEXILATE MESYLATE PRADAXA	022512 Product 022512/003	CAPSULE · ORAL EQ 110MG BASE FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	2
DABIGATRAN ETEXILATE MESYLATE PRADAXA	214358 Product 214358/001	PELLETS · ORAL EQ 20MG BASE/PACKET FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	1
DABIGATRAN ETEXILATE MESYLATE PRADAXA	214358 Product 214358/002	PELLETS · ORAL EQ 30MG BASE/PACKET FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	1
DABIGATRAN ETEXILATE MESYLATE PRADAXA	214358 Product 214358/003	PELLETS · ORAL EQ 40MG BASE/PACKET FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	1
DABIGATRAN ETEXILATE MESYLATE PRADAXA	214358 Product 214358/004	PELLETS · ORAL EQ 50MG BASE/PACKET FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	1
DABIGATRAN ETEXILATE MESYLATE PRADAXA	214358 Product 214358/005	PELLETS · ORAL EQ 110MG BASE/PACKET FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	1
DABIGATRAN ETEXILATE MESYLATE PRADAXA	214358 Product 214358/006	PELLETS · ORAL EQ 150MG BASE/PACKET FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	1
DABRAFENIB MESYLATE TAFINLAR	202806 Product 202806/001	CAPSULE · ORAL EQ 50MG BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	6
DABRAFENIB MESYLATE TAFINLAR	202806 Product 202806/002	CAPSULE · ORAL EQ 75MG BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	6
DABRAFENIB MESYLATE TAFINLAR	217514 Product 217514/001	TABLET, FOR SUSPENSION · ORAL EQ 10MG BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	4
DACLATASVIR DIHYDROCHLORIDE DAKLINZA	206843 Product 206843/001	TABLET · ORAL EQ 30MG BASE FDA marketing: DISCONTINUED	2019 DISQUALIFIED FINAL	5
DACLATASVIR DIHYDROCHLORIDE DAKLINZA	206843 Product 206843/002	TABLET · ORAL EQ 60MG BASE FDA marketing: DISCONTINUED	2019 DISQUALIFIED FINAL	5
DACLATASVIR DIHYDROCHLORIDE DAKLINZA	206843 Product 206843/003	TABLET · ORAL EQ 90MG BASE FDA marketing: DISCONTINUED	2019 DISQUALIFIED FINAL	1
daclizumab Zinbryta	761029 Product 761029/001	Injection · Subcutaneous 150MG/ML Pre-Filled Syringe FDA marketing: Prescription	2018 WITHDRAWN FINAL	0
DACOMITINIB VIZIMPRO	211288 Product 211288/001	TABLET · ORAL 15MG FDA marketing: Discontinued	Master only	3
DACOMITINIB VIZIMPRO	211288 Product 211288/002	TABLET · ORAL 30MG FDA marketing: Discontinued	Master only	3
DACOMITINIB VIZIMPRO	211288 Product 211288/003	TABLET · ORAL 45MG FDA marketing: Discontinued	Master only	3
DALBAVANCIN HYDROCHLORIDE DALVANCE	021883 Product 021883/001	POWDER · INTRAVENOUS EQ 500MG BASE/VIAL FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
DALFAMPRIDINE AMPYRA	022250 Product 022250/001	TABLET, EXTENDED RELEASE · ORAL 10MG FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
DALTEPARIN SODIUM FRAGMIN	020287 Product 020287/012	INJECTABLE · SUBCUTANEOUS 10,000IU/4ML (2,500IU/ML) FDA marketing: Prescription	1999 DEEP_REVIEW FINAL	0
DANICOPAN VOYDEYA	218037 Product 218037/001	TABLET · ORAL 50MG FDA marketing: Prescription	2038 CANDIDATE FINAL	2
DANICOPAN VOYDEYA	218037 Product 218037/002	TABLET · ORAL 100MG FDA marketing: Prescription	2038 CANDIDATE FINAL	2
DANTROLENE SODIUM RYANODEX	205579 Product 205579/001	FOR SUSPENSION · INTRAVENOUS 250MG/VIAL FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	5
DAPAGLIFLOZIN FARXIGA	202293 Product 202293/001	TABLET · ORAL 5MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	11
DAPAGLIFLOZIN FARXIGA	202293 Product 202293/002	TABLET · ORAL 10MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	17
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE XIGDUO XR	205649 Product 205649/001	TABLET, EXTENDED RELEASE · ORAL 5MG;500MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	5
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE XIGDUO XR	205649 Product 205649/002	TABLET, EXTENDED RELEASE · ORAL 5MG;1GM FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	5
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE XIGDUO XR	205649 Product 205649/003	TABLET, EXTENDED RELEASE · ORAL 10MG;500MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	5
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE XIGDUO XR	205649 Product 205649/004	TABLET, EXTENDED RELEASE · ORAL 10MG;1GM FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	5
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE XIGDUO XR	205649 Product 205649/005	TABLET, EXTENDED RELEASE · ORAL 2.5MG;1GM FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	5
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE QTERNMET XR	210874 Product 210874/001	TABLET, EXTENDED RELEASE · ORAL 2.5MG;1GM;EQ 2.5MG BASE FDA marketing: DISCONTINUED	2020 DISQUALIFIED FINAL	5
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE QTERNMET XR	210874 Product 210874/002	TABLET, EXTENDED RELEASE · ORAL 5MG;1GM;EQ 2.5MG BASE FDA marketing: DISCONTINUED	2020 DISQUALIFIED FINAL	5
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE QTERNMET XR	210874 Product 210874/003	TABLET, EXTENDED RELEASE · ORAL 5MG;1GM;EQ 5MG BASE FDA marketing: DISCONTINUED	2020 DISQUALIFIED FINAL	5
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE QTERNMET XR	210874 Product 210874/004	TABLET, EXTENDED RELEASE · ORAL 10MG;1GM;EQ 5MG BASE FDA marketing: DISCONTINUED	2020 DISQUALIFIED FINAL	5
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE QTERN	209091 Product 209091/001	TABLET · ORAL 10MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2026 DISQUALIFIED FINAL	6
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE QTERN	209091 Product 209091/002	TABLET · ORAL 5MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	6
DAPRODUSTAT JESDUVROQ	216951 Product 216951/001	TABLET · ORAL 1MG FDA marketing: DISCONTINUED	2024 DISQUALIFIED FINAL	6
DAPRODUSTAT JESDUVROQ	216951 Product 216951/002	TABLET · ORAL 2MG FDA marketing: DISCONTINUED	2024 DISQUALIFIED FINAL	6
DAPRODUSTAT JESDUVROQ	216951 Product 216951/003	TABLET · ORAL 4MG FDA marketing: DISCONTINUED	2024 DISQUALIFIED FINAL	6
DAPRODUSTAT JESDUVROQ	216951 Product 216951/004	TABLET · ORAL 6MG FDA marketing: DISCONTINUED	2024 DISQUALIFIED FINAL	6
DAPRODUSTAT JESDUVROQ	216951 Product 216951/005	TABLET · ORAL 8MG FDA marketing: DISCONTINUED	2024 DISQUALIFIED FINAL	6
DAPSONE ACZONE	207154 Product 207154/001	GEL · TOPICAL 7.5% FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	1
DAPTOMYCIN CUBICIN RF	021572 Product 021572/003	POWDER · INTRAVENOUS 500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2022 DISCONTINUED FINAL	1
DAPTOMYCIN DAPTOMYCIN	208385 Product 208385/001	POWDER · INTRAVENOUS 350MG/VIAL FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	0
DAPTOMYCIN DAPTOMYCIN	209949 Product 209949/001	POWDER · INTRAVENOUS 350MG/VIAL FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	0
DAPTOMYCIN DAPTOMYCIN	210282 Product 210282/001	POWDER · INTRAVENOUS 350MG/VIAL FDA marketing: Prescription	2033 CANDIDATE FINAL	2
DAPTOMYCIN DAPTOMYCIN	210282 Product 210282/002	POWDER · INTRAVENOUS 500MG/VIAL FDA marketing: Prescription	2033 CANDIDATE FINAL	2
DAPTOMYCIN DAPTOMYCIN	217415 Product 217415/001	POWDER · INTRAVENOUS 350MG/VIAL FDA marketing: Prescription	2038 DEEP_REVIEW FINAL	3
DAPTOMYCIN DAPTOMYCIN	217415 Product 217415/002	POWDER · INTRAVENOUS 500MG/VIAL FDA marketing: Prescription	2038 DEEP_REVIEW FINAL	3
DAPTOMYCIN DAPTOMYCIN	217630 Product 217630/001	POWDER · INTRAVENOUS 350MG/VIAL FDA marketing: Discontinued	DISCONTINUED FINAL	0
DAPTOMYCIN DAPTOMYCIN	217630 Product 217630/002	POWDER · INTRAVENOUS 500MG/VIAL FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
DAPTOMYCIN DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	213645 Product 213645/002	SOLUTION · INTRAVENOUS 350MG/50ML (7MG/ML) FDA marketing: Prescription	2008 DEEP_REVIEW FINAL	1
DAPTOMYCIN DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	213645 Product 213645/003	SOLUTION · INTRAVENOUS 500MG/50ML (10MG/ML) FDA marketing: Prescription	2008 DEEP_REVIEW FINAL	1
DAPTOMYCIN DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	213645 Product 213645/004	SOLUTION · INTRAVENOUS 700MG/100ML (7MG/ML) FDA marketing: Prescription	2008 DEEP_REVIEW FINAL	1
DAPTOMYCIN DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	213645 Product 213645/005	SOLUTION · INTRAVENOUS 1GM/100ML (10MG/ML) FDA marketing: Prescription	2008 DEEP_REVIEW FINAL	1
DAPTOMYCIN DAPZURA RT	213645 Product 213645/001	POWDER · INTRAVENOUS 500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2022 DISCONTINUED FINAL	1
daratumumab Darzalex	761036 Product 761036/001	Injection · Intravenous 100MG/5ML Single-Dose Vial FDA marketing: Prescription	2029 CANDIDATE FINAL	0
daratumumab Darzalex	761036 Product 761036/002	Injection · Intravenous 400MG/20ML Single-Dose Vial FDA marketing: Prescription	2029 CANDIDATE FINAL	0
daratumumab and hyaluronidase-fihj Darzalex Faspro	761145 Product 761145/001	Injection · Subcutaneous 1800MG/15ML; 30,000UNITS/15ML (120MG/2,000UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	0
DARAXONRASIB RASONQUE	220910 Product 220910/001	TABLET · ORAL 100MG FDA marketing: Prescription	2042 CANDIDATE FINAL	2
DARAXONRASIB RASONQUE	220910 Product 220910/002	TABLET · ORAL 150MG FDA marketing: Prescription	2042 CANDIDATE FINAL	2
DARIDOREXANT HYDROCHLORIDE QUVIVIQ	214985 Product 214985/001	TABLET · ORAL EQ 25MG BASE FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	3
DARIDOREXANT HYDROCHLORIDE QUVIVIQ	214985 Product 214985/002	TABLET · ORAL EQ 50MG BASE FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	3
DAROLUTAMIDE NUBEQA	212099 Product 212099/001	TABLET · ORAL 300MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	10
DARUNAVIR PREZISTA	021976 Product 021976/006	TABLET · ORAL 800MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	1
DARUNAVIR PREZISTA	202895 Product 202895/001	SUSPENSION · ORAL 100MG/ML FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	1
DARUNAVIR AND COBICISTAT PREZCOBIX	220092 Product 220092/002	TABLET, FOR SUSPENSION · ORAL 675MG/150MG FDA marketing: Prescription	Master only	0
DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR VIEKIRA PAK (COPACKAGED)	206619 Product 206619/001	TABLET · ORAL EQ 250MG BASE;12.5MG, 75MG, 50MG FDA marketing: DISCONTINUED	2021 DISQUALIFIED FINAL	15
DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR VIEKIRA XR	208624 Product 208624/001	TABLET, EXTENDED RELEASE · ORAL EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2019 DISQUALIFIED FINAL	18
DASATINIB DASATINIB	219579 Product 219579/001	TABLET · ORAL 20MG FDA marketing: Prescription	Master only	0
DASATINIB DASATINIB	219579 Product 219579/002	TABLET · ORAL 50MG FDA marketing: Prescription	Master only	0
DASATINIB DASATINIB	219579 Product 219579/003	TABLET · ORAL 70MG FDA marketing: Prescription	Master only	0
DASATINIB DASATINIB	219579 Product 219579/004	TABLET · ORAL 80MG FDA marketing: Prescription	Master only	0
DASATINIB DASATINIB	219579 Product 219579/005	TABLET · ORAL 100MG FDA marketing: Prescription	Master only	0
DASATINIB DASATINIB	219579 Product 219579/006	TABLET · ORAL 140MG FDA marketing: Prescription	Master only	0
DASATINIB PHYRAGO	216099 Product 216099/001	TABLET · ORAL 20MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	6
DASATINIB PHYRAGO	216099 Product 216099/002	TABLET · ORAL 50MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	6
DASATINIB PHYRAGO	216099 Product 216099/003	TABLET · ORAL 70MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	6
DASATINIB PHYRAGO	216099 Product 216099/004	TABLET · ORAL 80MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	6
DASATINIB PHYRAGO	216099 Product 216099/005	TABLET · ORAL 100MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	6
DASATINIB PHYRAGO	216099 Product 216099/006	TABLET · ORAL 140MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	6
DASATINIB SPRYCEL	021986 Product 021986/005	TABLET · ORAL 80MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	1
DASATINIB SPRYCEL	021986 Product 021986/006	TABLET · ORAL 140MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	1
DASIGLUCAGON HYDROCHLORIDE ZEGALOGUE	214231 Product 214231/001	SOLUTION · SUBCUTANEOUS EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	2
DASIGLUCAGON HYDROCHLORIDE ZEGALOGUE (AUTOINJECTOR)	214231 Product 214231/002	SOLUTION · SUBCUTANEOUS EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	2
datopotamab deruxtecan-dlnk Datroway	761394 Product 761394/001	Injection · Intravenous 100MG Single-Dose Vial FDA marketing: Prescription	2037 DEEP_REVIEW FINAL_CHECKING	2
DAXIBOTULINUMTOXINA-LANM DAXXIFY	761127 Product 761127/001	INJECTABLE · INTRAMUSCULAR, SUBCUTANEOUS 0.1ML FDA marketing: Prescription	Master only	0
DECITABINE DECITABINE	205582 Product 205582/001	POWDER · INTRAVENOUS 50MG/VIAL FDA marketing: Discontinued	2025 DISCONTINUED FINAL	0
DEFERASIROX JADENU	206910 Product 206910/001	TABLET · ORAL 90MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	1
DEFERASIROX JADENU	206910 Product 206910/002	TABLET · ORAL 180MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	1
DEFERASIROX JADENU	206910 Product 206910/003	TABLET · ORAL 360MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	1
DEFERASIROX JADENU SPRINKLE	207968 Product 207968/001	GRANULE · ORAL 90MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	0
DEFERASIROX JADENU SPRINKLE	207968 Product 207968/002	GRANULE · ORAL 180MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	0
DEFERASIROX JADENU SPRINKLE	207968 Product 207968/003	GRANULE · ORAL 360MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	0
DEFERIPRONE FERRIPROX	021825 Product 021825/001	TABLET · ORAL 500MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	0
DEFERIPRONE FERRIPROX	021825 Product 021825/002	TABLET · ORAL 1GM FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
DEFERIPRONE FERRIPROX	208030 Product 208030/001	SOLUTION · ORAL 100MG/ML FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	1
DEFERIPRONE FERRIPROX	208030 Product 208030/002	SOLUTION · ORAL 80MG/ML FDA marketing: Discontinued	2021 DISCONTINUED FINAL	1
DEFERIPRONE FERRIPROX	212269 Product 212269/001	TABLET · ORAL 1GM FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	6
DEFIBROTIDE SODIUM DEFITELIO	208114 Product 208114/001	SOLUTION · INTRAVENOUS 200MG/2.5ML (80MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	5
DEFLAZACORT DEFLAZACORT	217103 Product 217103/001	TABLET · ORAL 6MG FDA marketing: Prescription	Master only	0
DEFLAZACORT DEFLAZACORT	217103 Product 217103/002	TABLET · ORAL 18MG FDA marketing: Prescription	Master only	0
DEFLAZACORT DEFLAZACORT	217103 Product 217103/003	TABLET · ORAL 30MG FDA marketing: Prescription	Master only	0
DEFLAZACORT DEFLAZACORT	217103 Product 217103/004	TABLET · ORAL 36MG FDA marketing: Prescription	Master only	0
DEFLAZACORT DEFLAZACORT	220524 Product 220524/001	TABLET · ORAL 6MG FDA marketing: Prescription	Master only	0
DEFLAZACORT DEFLAZACORT	220524 Product 220524/002	TABLET · ORAL 18MG FDA marketing: Prescription	Master only	0
DEFLAZACORT DEFLAZACORT	220524 Product 220524/003	TABLET · ORAL 30MG FDA marketing: Prescription	Master only	0
DEFLAZACORT DEFLAZACORT	220524 Product 220524/004	TABLET · ORAL 36MG FDA marketing: Prescription	Master only	0
DEFLAZACORT EMFLAZA	208684 Product 208684/001	TABLET · ORAL 6MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
DEFLAZACORT EMFLAZA	208684 Product 208684/002	TABLET · ORAL 18MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
DEFLAZACORT EMFLAZA	208684 Product 208684/003	TABLET · ORAL 30MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
DEFLAZACORT EMFLAZA	208684 Product 208684/004	TABLET · ORAL 36MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
DEFLAZACORT EMFLAZA	208685 Product 208685/001	SUSPENSION · ORAL 22.75MG/ML FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
DEHYDRATED ALCOHOL ABLYSINOL	207987 Product 207987/001	SOLUTION · INTRA-ARTERIAL 99% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2025 DEEP_REVIEW PROVISIONAL	0
DEHYDRATED ALCOHOL ABLYSINOL	207987 Product 207987/002	SOLUTION · INTRA-ARTERIAL 99% (5ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
DEHYDRATED ALCOHOL DEHYDRATED ALCOHOL	214988 Product 214988/001	SOLUTION · INTRAVENOUS 98% (5ML) FDA marketing: Prescription	2032 CANDIDATE FINAL	0
DELAFLOXACIN MEGLUMINE BAXDELA	208610 Product 208610/001	TABLET · ORAL EQ 450MG BASE FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	5
DELAFLOXACIN MEGLUMINE BAXDELA	208611 Product 208611/001	POWDER · INTRAVENOUS EQ 300MG BASE/VIAL FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	13
DELGOCITINIB ANZUPGO	219155 Product 219155/001	CREAM · TOPICAL 2% FDA marketing: Prescription	2031 CANDIDATE FINAL	1
denileukin diftitox-cxdl Lymphir	761312 Product 761312/001	For Injection · Intravenous 300MCG Single-Dose Vial FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	0
denosumab Prolia	125320 Product 125320/001	Injection · Subcutaneous 60MG/ML Pre-Filled Syringe FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	57
denosumab Xgeva	125320 Product 125320/003	Injection · Subcutaneous 120MG/1.7ML (70MG/ML) Single-Dose Vial FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	57
denosumab-adet Degevma	761481 Product 761481/001	Injection · Subcutaneous 120MG/1.7ML (70MG/ML) Single-Dose Vial FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-adet Ponlimsi	761385 Product 761385/001	Injection · Subcutaneous 60MG/ML Pre-Filled Syringe FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-bbdz Jubbonti	761362 Product 761362/001	Injection · Subcutaneous 60MG/ML Pre-Filled Syringe FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-bbdz Wyost	761362 Product 761362/002	Injection · Subcutaneous 120MG/1.7ML (70MG/ML) Single-Dose Vial FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-bmwo Osenvelt	761404 Product 761404/002	Injection · Subcutaneous 120MG/1.7ML (70MG/ML) Single-Dose Vial FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-bmwo Stoboclo	761404 Product 761404/001	Injection · Subcutaneous 60MG/ML Pre-Filled Syringe FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
DENOSUMAB-BNHT BOMYNTRA	761398 Product 761398/001	INJECTION 120MG/1.7ML (70 MG/ML) FDA marketing: Prescription	Master only	0
denosumab-bnht Conexxence	761398 Product 761398/001	Injection · Subcutaneous 60MG/ML Pre-Filled Syringe FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-desu Jubereq	761424 Product 761424/002	Injection · Subcutaneous 120MG/1.7ML (70MG/ML) Single-Dose Vial FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-desu Osvyrti	761424 Product 761424/001	Injection · Subcutaneous 60MG/ML Pre-Filled Syringe FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-dssb Ospomyv	761392 Product 761392/001	Injection · Subcutaneous 60MG/ML Pre-Filled Syringe FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-dssb Xbryk	761392 Product 761392/002	Injection · Subcutaneous 120MG/1.7ML (70MG/ML) Single-Dose Vial FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-kyqq Aukelso	761436 Product 761436/002	Injection · Subcutaneous 120MG/1.7ML (70MG/ML) Single-Dose Vial FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-kyqq Bosaya	761436 Product 761436/001	Injection · Subcutaneous 60MG/ML Pre-Filled Syringe FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-mobz Boncresa	761456 Product 761456/001	Injection · Subcutaneous 60MG/ML Pre-Filled Syringe FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-mobz Oziltus	761457 Product 761457/001	Injection · Subcutaneous 120MG/1.7ML (70MG/ML) Single-Dose Vial FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-nxxp Bildyos	761444 Product 761444/001	Injection · Subcutaneous 60MG/ML Single-Dose Vial FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-nxxp Bilprevda	761444 Product 761444/003	Injection · Subcutaneous 120MG/1.7ML (70MG/ML) Single-Dose Vial FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-qbde Enoby	761439 Product 761439/001	Injection · Subcutaneous 60MG/ML Pre-Filled Syringe FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
denosumab-qbde Xtrenbo	761439 Product 761439/002	Injection · Subcutaneous 120MG/1.7ML (70MG/ML) Single-Dose Vial FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
DEOXYCHOLIC ACID KYBELLA	206333 Product 206333/001	SOLUTION · SUBCUTANEOUS 20MG/2ML (10MG/ML) FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	14
depemokimab-ulaa Exdensur	761458 Product 761458/001	Injection · Subcutaneous 100MG/ML Autoinjector FDA marketing: Prescription	2026 DISCONTINUED FINAL	0
DESFLURANE DESFLURANE	090363 Product 090363/001	LIQUID · INHALATION 100% FDA marketing: Prescription	Master only	0
DESMOPRESSIN ACETATE DESMODA	219873 Product 219873/001	SOLUTION · ORAL 0.05MG/ML FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	2
DESMOPRESSIN ACETATE NOCDURNA	022517 Product 022517/001	TABLET · SUBLINGUAL 0.0277MG FDA marketing: Discontinued	2023 DISCONTINUED FINAL	3
DESMOPRESSIN ACETATE NOCDURNA	022517 Product 022517/002	TABLET · SUBLINGUAL 0.0553MG FDA marketing: Discontinued	2023 DISCONTINUED FINAL	3
DESMOPRESSIN ACETATE NOCTIVA	201656 Product 201656/001	SPRAY, METERED · NASAL 0.00083MG/SPRAY FDA marketing: Discontinued	2019 DISCONTINUED FINAL	3
DESMOPRESSIN ACETATE NOCTIVA	201656 Product 201656/002	SPRAY, METERED · NASAL 0.00166MG/SPRAY FDA marketing: Discontinued	2019 DISCONTINUED FINAL	3
DESOXIMETASONE TOPICORT	204141 Product 204141/001	SPRAY · TOPICAL 0.25% FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	2
DESVENLAFAXINE DESVENLAFAXINE	204150 Product 204150/001	TABLET, EXTENDED RELEASE · ORAL 50MG FDA marketing: RX	2013 DEEP_REVIEW FINAL	0
DESVENLAFAXINE DESVENLAFAXINE	204150 Product 204150/002	TABLET, EXTENDED RELEASE · ORAL 100MG FDA marketing: RX	2013 DEEP_REVIEW FINAL	0
DESVENLAFAXINE KHEDEZLA	204683 Product 204683/001	TABLET, EXTENDED RELEASE · ORAL 50MG FDA marketing: WITHDRAWN	2022 WITHDRAWN FINAL	0
DESVENLAFAXINE KHEDEZLA	204683 Product 204683/002	TABLET, EXTENDED RELEASE · ORAL 100MG FDA marketing: WITHDRAWN	2022 WITHDRAWN FINAL	0
DESVENLAFAXINE FUMARATE DESVENLAFAXINE	205208 Product 205208/001	TABLET, EXTENDED RELEASE · ORAL EQ 50MG BASE FDA marketing: Discontinued	2017 WITHDRAWN FINAL	0
DESVENLAFAXINE FUMARATE DESVENLAFAXINE	205208 Product 205208/002	TABLET, EXTENDED RELEASE · ORAL EQ 100MG BASE FDA marketing: Discontinued	2017 WITHDRAWN FINAL	0
DESVENLAFAXINE FUMARATE DESVENLAFAXINE	205583 Product 205583/001	TABLET, EXTENDED RELEASE · ORAL EQ 50MG BASE FDA marketing: Discontinued	2018 DISCONTINUED FINAL	0
DESVENLAFAXINE FUMARATE DESVENLAFAXINE	205583 Product 205583/002	TABLET, EXTENDED RELEASE · ORAL EQ 100MG BASE FDA marketing: Discontinued	2018 DISCONTINUED FINAL	0
DESVENLAFAXINE SUCCINATE PRISTIQ	021992 Product 021992/003	TABLET, EXTENDED RELEASE · ORAL EQ 25MG BASE FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	1
DEUCRAVACITINIB SOTYKTU	214958 Product 214958/001	TABLET · ORAL 6MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	5
DEURUXOLITINIB PHOSPHATE LEQSELVI	217900 Product 217900/001	TABLET · ORAL EQ 8MG BASE FDA marketing: Prescription	2044 CANDIDATE FINAL	6
DEUTETRABENAZINE AUSTEDO	208082 Product 208082/001	TABLET · ORAL 6MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	14
DEUTETRABENAZINE AUSTEDO	208082 Product 208082/002	TABLET · ORAL 9MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	14
DEUTETRABENAZINE AUSTEDO	208082 Product 208082/003	TABLET · ORAL 12MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	14
DEUTETRABENAZINE AUSTEDO XR	216354 Product 216354/001	TABLET, EXTENDED RELEASE · ORAL 6MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	13
DEUTETRABENAZINE AUSTEDO XR	216354 Product 216354/002	TABLET, EXTENDED RELEASE · ORAL 12MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	13
DEUTETRABENAZINE AUSTEDO XR	216354 Product 216354/003	TABLET, EXTENDED RELEASE · ORAL 24MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	13
DEUTETRABENAZINE AUSTEDO XR	216354 Product 216354/004	TABLET, EXTENDED RELEASE · ORAL 30MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	13
DEUTETRABENAZINE AUSTEDO XR	216354 Product 216354/005	TABLET, EXTENDED RELEASE · ORAL 36MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	13
DEUTETRABENAZINE AUSTEDO XR	216354 Product 216354/006	TABLET, EXTENDED RELEASE · ORAL 42MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	13
DEUTETRABENAZINE AUSTEDO XR	216354 Product 216354/007	TABLET, EXTENDED RELEASE · ORAL 48MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	13
DEUTETRABENAZINE AUSTEDO XR	216354 Product 216354/008	TABLET, EXTENDED RELEASE · ORAL 18MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	13
DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM ALYFTREK	218730 Product 218730/001	TABLET · ORAL 50MG;20MG;EQ 4MG BASE FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	28
DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM ALYFTREK	218730 Product 218730/002	TABLET · ORAL 125MG;50MG;EQ 10MG BASE FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	33
DEXAMETHASONE DEXTENZA	208742 Product 208742/001	INSERT · OPHTHALMIC 0.4MG FDA marketing: Prescription	2018 DEEP_REVIEW FINAL_CHECKING	5
DEXAMETHASONE DEXYCU KIT	208912 Product 208912/001	SUSPENSION · INTRAOCULAR 9% FDA marketing: Discontinued	2026 DISCONTINUED FINAL	5
DEXAMETHASONE HEMADY	211379 Product 211379/001	TABLET · ORAL 20MG FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	2
DEXLANSOPRAZOLE DEXILANT SOLUTAB	208056 Product 208056/001	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE · ORAL 30MG FDA marketing: Discontinued	2017 DISCONTINUED FINAL	5
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE	206628 Product 206628/001	SOLUTION · INTRAVENOUS EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE	206628 Product 206628/002	SOLUTION · INTRAVENOUS EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE	206628 Product 206628/003	SOLUTION · INTRAVENOUS EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	2
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE	206628 Product 206628/004	SOLUTION · INTRAVENOUS EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	2
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE	216254 Product 216254/001	INJECTABLE · INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) FDA marketing: Prescription	Master only	0
DEXMEDETOMIDINE HYDROCHLORIDE IGALMI	215390 Product 215390/001	FILM · BUCCAL, SUBLINGUAL EQ 0.12MG BASE FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	14
DEXMEDETOMIDINE HYDROCHLORIDE IGALMI	215390 Product 215390/002	FILM · BUCCAL, SUBLINGUAL EQ 0.18MG BASE FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	14
DEXMEDETOMIDINE HYDROCHLORIDE PRECEDEX	021038 Product 021038/002	INJECTABLE · INJECTION EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	7
DEXMEDETOMIDINE HYDROCHLORIDE PRECEDEX	021038 Product 021038/003	INJECTABLE · INJECTION EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	7
DEXMEDETOMIDINE HYDROCHLORIDE PRECEDEX	021038 Product 021038/004	INJECTABLE · INJECTION EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	6
DEXMEDETOMIDINE HYDROCHLORIDE PRECEDEX	021038 Product 021038/005	INJECTABLE · INJECTION EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
DEXMETHYLPHENIDATE HYDROCHLORIDE FOCALIN XR	021802 Product 021802/006	CAPSULE, EXTENDED RELEASE · ORAL 40MG FDA marketing: Prescription	2013 EXISTING_GENERIC DISQUALIFIED	0
DEXMETHYLPHENIDATE HYDROCHLORIDE FOCALIN XR	021802 Product 021802/007	CAPSULE, EXTENDED RELEASE · ORAL 35MG FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
DEXMETHYLPHENIDATE HYDROCHLORIDE FOCALIN XR	021802 Product 021802/008	CAPSULE, EXTENDED RELEASE · ORAL 25MG FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE AZSTARYS	212994 Product 212994/001	CAPSULE · ORAL EQ 5.2MG BASE;EQ 26.1MG BASE FDA marketing: Prescription	2037 CANDIDATE FINAL	6
DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE AZSTARYS	212994 Product 212994/002	CAPSULE · ORAL EQ 7.8MG BASE;EQ 39.2MG BASE FDA marketing: Prescription	2037 CANDIDATE FINAL	6
DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE AZSTARYS	212994 Product 212994/003	CAPSULE · ORAL EQ 10.4MG BASE;EQ 52.3MG BASE FDA marketing: Prescription	2037 CANDIDATE FINAL	6
DEXTROAMPHETAMINE XELSTRYM	215401 Product 215401/001	SYSTEM · TRANSDERMAL 4.5MG/9HR FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	4
DEXTROAMPHETAMINE XELSTRYM	215401 Product 215401/002	SYSTEM · TRANSDERMAL 9MG/9HR FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	4
DEXTROAMPHETAMINE XELSTRYM	215401 Product 215401/003	SYSTEM · TRANSDERMAL 13.5MG/9HR FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	4
DEXTROAMPHETAMINE XELSTRYM	215401 Product 215401/004	SYSTEM · TRANSDERMAL 18MG/9HR FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	4
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM	217338 Product 217338/001	TABLET, EXTENDED RELEASE · ORAL 30MG;600MG;110MG FDA marketing: Over-the-counter	2025 EXCLUDED FINAL	3
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE NUEDEXTA	021879 Product 021879/001	CAPSULE · ORAL 20MG;10MG FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	1
DEXTROSE DEXTROSE 70% IN PLASTIC CONTAINER	019626 Product 019626/005	INJECTABLE · INJECTION 70GM/100ML FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	0
DIAZEPAM VALTOCO	211635 Product 211635/001	SPRAY · NASAL 5MG/SPRAY FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	8
DIAZEPAM VALTOCO	211635 Product 211635/002	SPRAY · NASAL 7.5MG/SPRAY FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	8
DIAZEPAM VALTOCO	211635 Product 211635/003	SPRAY · NASAL 10MG/SPRAY FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	8
DIAZOXIDE CHOLINE VYKAT XR	216665 Product 216665/001	TABLET, EXTENDED RELEASE · ORAL 25MG FDA marketing: Prescription	2035 CANDIDATE FINAL	6
DIAZOXIDE CHOLINE VYKAT XR	216665 Product 216665/002	TABLET, EXTENDED RELEASE · ORAL 75MG FDA marketing: Prescription	2035 CANDIDATE FINAL	6
DIAZOXIDE CHOLINE VYKAT XR	216665 Product 216665/003	TABLET, EXTENDED RELEASE · ORAL 150MG FDA marketing: Prescription	2035 CANDIDATE FINAL	6
DICHLORPHENAMIDE KEVEYIS	011366 Product 011366/002	TABLET · ORAL 50MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
DICLOFENAC ZORVOLEX	204592 Product 204592/001	CAPSULE · ORAL 18MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2020 DISCONTINUED FINAL	7
DICLOFENAC ZORVOLEX	204592 Product 204592/002	CAPSULE · ORAL 35MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2022 DISCONTINUED FINAL	7
DICLOFENAC EPOLAMINE LICART	206976 Product 206976/001	SYSTEM · TOPICAL 1.3% FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	2
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM	075229 Product 075229/003	TABLET · ORAL 75MG FDA marketing: Prescription	Master only	0
DICLOFENAC SODIUM DYLOJECT	022396 Product 022396/001	SOLUTION · INTRAVENOUS 37.5MG/ML (37.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2018 DISCONTINUED FINAL	1
DICLOFENAC SODIUM PENNSAID	204623 Product 204623/001	SOLUTION · TOPICAL 2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2024 DISCONTINUED FINAL	19
DICLOFENAC SODIUM ZUEINO	218379 Product 218379/001	INJECTABLE · INTRAVENOUS 37.5MG/ML FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
DIENOGEST; ESTRADIOL VALERATE NATAZIA	022252 Product 022252/001	TABLET · ORAL N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A FDA marketing: RX	2026 DEEP_REVIEW FINAL	2
DIFAMILAST ADQUEY	219474 Product 219474/001	OINTMENT · TOPICAL 1% FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	2
DIFELIKEFALIN ACETATE KORSUVA	214916 Product 214916/001	SOLUTION · INTRAVENOUS EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	12
DIHYDROERGOTAMINE MESYLATE ATZUMI	217901 Product 217901/001	POWDER · NASAL EQ 5.2MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	7
DIHYDROERGOTAMINE MESYLATE BREKIYA (AUTOINJECTOR)	215400 Product 215400/001	SOLUTION · SUBCUTANEOUS 1MG/ML FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	8
DIHYDROERGOTAMINE MESYLATE TRUDHESA	213436 Product 213436/001	SPRAY, METERED · NASAL 0.725MG/SPRAY FDA marketing: Prescription	2024 DEEP_REVIEW FINAL_CHECKING	6
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE	220590 Product 220590/001	TABLET · ORAL 30MG FDA marketing: Prescription	Master only	0
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE	220590 Product 220590/002	TABLET · ORAL 60MG FDA marketing: Prescription	Master only	0
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE	220590 Product 220590/003	TABLET · ORAL 90MG FDA marketing: Prescription	Master only	0
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE	220590 Product 220590/004	TABLET · ORAL 120MG FDA marketing: Prescription	Master only	0
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE	218038 Product 218038/001	SOLUTION · INTRAVENOUS 100MG/100ML (1MG/ML) FDA marketing: Prescription	1992 CANDIDATE FINAL	0
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE	218038 Product 218038/002	SOLUTION · INTRAVENOUS 250MG/250ML (1MG/ML) FDA marketing: Prescription	1992 CANDIDATE FINAL	0
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	215252 Product 215252/001	SOLUTION · INTRAVENOUS 125MG/125ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2022 DISQUALIFIED FINAL	0
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	215252 Product 215252/002	SOLUTION · INTRAVENOUS 250MG/250ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2022 DISQUALIFIED FINAL	0
DIMETHYL FUMARATE TECFIDERA	204063 Product 204063/001	CAPSULE, DELAYED RELEASE · ORAL 120MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	9
DIMETHYL FUMARATE TECFIDERA	204063 Product 204063/002	CAPSULE, DELAYED RELEASE · ORAL 240MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	9
dinutuximab Unituxin	125516 Product 125516/001	Injection · Intravenous 17.5MG/5ML (3.5MG/ML) Single-Dose Vial FDA marketing: Prescription	2027 CANDIDATE FINAL	0
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM ALEVE PM	205352 Product 205352/001	TABLET · ORAL 25MG;220MG FDA marketing: Over-the-counter	2014 EXCLUDED FINAL	0
DIROXIMEL FUMARATE VUMERITY	211855 Product 211855/001	CAPSULE, DELAYED RELEASE · ORAL 231MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	3
DOCETAXEL BEIZRAY	218711 Product 218711/001	SOLUTION · INTRAVENOUS 80MG/4ML (20MG/ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL_CHECKING	3
DOCETAXEL BEIZRAY	218711 Product 218711/002	SOLUTION · INTRAVENOUS 20MG/ML (20MG/ML) FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	4
DOCETAXEL DOCEFREZ	022534 Product 022534/001	INJECTABLE · INJECTION 20MG/VIAL FDA marketing: Discontinued	2016 DISCONTINUED FINAL	0
DOCETAXEL DOCEFREZ	022534 Product 022534/002	INJECTABLE · INJECTION 80MG/VIAL FDA marketing: Discontinued	2014 DISCONTINUED FINAL	0
DOCETAXEL DOCETAXEL	022234 Product 022234/001	INJECTABLE · INJECTION 20MG/2ML (10MG/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
DOCETAXEL DOCETAXEL	022234 Product 022234/002	INJECTABLE · INJECTION 80MG/8ML (10MG/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
DOCETAXEL DOCETAXEL	022234 Product 022234/003	INJECTABLE · INJECTION 160MG/16ML (10MG/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
DOCETAXEL DOCETAXEL	022234 Product 022234/004	INJECTABLE · INJECTION 20MG/ML (20MG/ML) FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
DOCETAXEL DOCETAXEL	022234 Product 022234/005	INJECTABLE · INJECTION 80MG/4ML (20MG/ML) FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
DOCETAXEL DOCETAXEL	022234 Product 022234/006	INJECTABLE · INJECTION 120MG/6ML (20MG/ML) FDA marketing: Discontinued	2017 DISCONTINUED FINAL	0
DOCETAXEL DOCETAXEL	022234 Product 022234/007	INJECTABLE · INJECTION 160MG/8ML (20MG/ML) FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	0
DOCETAXEL DOCETAXEL	022312 Product 022312/001	INJECTABLE · INJECTION 20MG/0.5ML (40MG/ML) FDA marketing: Discontinued	2016 WITHDRAWN FINAL	0
DOCETAXEL DOCETAXEL	022312 Product 022312/002	INJECTABLE · INJECTION 80MG/2ML (40MG/ML) FDA marketing: Discontinued	2016 WITHDRAWN FINAL	0
DOCETAXEL DOCETAXEL	022534 Product 022534/003	INJECTABLE · INJECTION 20MG/ML (20MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
DOCETAXEL DOCETAXEL	022534 Product 022534/004	INJECTABLE · INJECTION 80MG/4ML (20MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
DOCETAXEL DOCETAXEL	022534 Product 022534/005	INJECTABLE · INJECTION 160MG/8ML (20MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
DOCETAXEL DOCETAXEL	201195 Product 201195/001	INJECTABLE · INJECTION 20MG/0.5ML (40MG/ML) FDA marketing: Discontinued	2018 DISCONTINUED FINAL	0
DOCETAXEL DOCETAXEL	201195 Product 201195/002	INJECTABLE · INJECTION 80MG/2ML (40MG/ML) FDA marketing: Discontinued	2018 DISCONTINUED FINAL	0
DOCETAXEL DOCETAXEL	201195 Product 201195/003	INJECTABLE · INJECTION 20MG/ML (20MG/ML) FDA marketing: Prescription	2014 EXISTING_GENERIC DISQUALIFIED	0
DOCETAXEL DOCETAXEL	201195 Product 201195/004	INJECTABLE · INJECTION 80MG/4ML (20MG/ML) FDA marketing: Prescription	2014 EXISTING_GENERIC DISQUALIFIED	0
DOCETAXEL DOCETAXEL	201195 Product 201195/005	INJECTABLE · INJECTION 160MG/8ML (20MG/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
DOCETAXEL DOCETAXEL	201525 Product 201525/001	INJECTABLE · INJECTION 20MG/2ML (10MG/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
DOCETAXEL DOCETAXEL	201525 Product 201525/002	INJECTABLE · INJECTION 80MG/8ML (10MG/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
DOCETAXEL DOCETAXEL	201525 Product 201525/003	INJECTABLE · INJECTION 160MG/16ML (10MG/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
DOCETAXEL DOCETAXEL	202356 Product 202356/001	INJECTABLE · INJECTION 20MG/2ML (10MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
DOCETAXEL DOCETAXEL	202356 Product 202356/002	INJECTABLE · INJECTION 80MG/8ML (10MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
DOCETAXEL DOCETAXEL	202356 Product 202356/003	INJECTABLE · INJECTION 130MG/13ML (10MG/ML) FDA marketing: Discontinued	2019 WITHDRAWN FINAL	0
DOCETAXEL DOCETAXEL	202356 Product 202356/004	INJECTABLE · INJECTION 200MG/20ML (10MG/ML) FDA marketing: Discontinued	2019 WITHDRAWN FINAL	0
DOCETAXEL DOCETAXEL	203551 Product 203551/001	INJECTABLE · INJECTION 20MG/ML (20MG/ML) FDA marketing: Prescription	2014 EXISTING_GENERIC DISQUALIFIED	0
DOCETAXEL DOCETAXEL	203551 Product 203551/002	INJECTABLE · INJECTION 80MG/4ML (20MG/ML) FDA marketing: Prescription	2014 EXISTING_GENERIC DISQUALIFIED	0
DOCETAXEL DOCETAXEL	203551 Product 203551/003	INJECTABLE · INJECTION 140MG/7ML (20MG/ML) FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
DOCETAXEL DOCETAXEL	203551 Product 203551/004	INJECTABLE · INJECTION 160MG/8ML (20MG/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
DOCETAXEL DOCETAXEL	205934 Product 205934/001	INJECTABLE · INJECTION 20MG/ML (20MG/ML) FDA marketing: Prescription	2014 EXISTING_GENERIC DISQUALIFIED	4
DOCETAXEL DOCETAXEL	205934 Product 205934/002	INJECTABLE · INJECTION 80MG/4ML (20MG/ML) FDA marketing: Prescription	2014 EXISTING_GENERIC DISQUALIFIED	4
DOCETAXEL DOCETAXEL	205934 Product 205934/003	INJECTABLE · INJECTION 160MG/8ML (20MG/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	4
DOCETAXEL DOCETAXEL	215813 Product 215813/004	INJECTABLE · INJECTION 160MG/16ML FDA marketing: Prescription	2001 DEEP_REVIEW FINAL	1
DOCETAXEL DOCIVYX	215813 Product 215813/001	SOLUTION · INTRAVENOUS 20MG/2ML (10MG/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	1
DOCETAXEL DOCIVYX	215813 Product 215813/002	SOLUTION · INTRAVENOUS 80MG/8ML (10MG/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	1
DOCETAXEL DOCIVYX	215813 Product 215813/003	SOLUTION · INTRAVENOUS 160MG/16ML (10MG/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	1
DOCETAXEL TAXOTERE	020449 Product 020449/003	INJECTABLE · INJECTION 20MG/ML (20MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	4
DOCETAXEL TAXOTERE	020449 Product 020449/004	INJECTABLE · INJECTION 80MG/4ML (20MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	4
DOCETAXEL TAXOTERE	020449 Product 020449/005	INJECTABLE · INJECTION 160MG/8ML (20MG/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
DOLUTEGRAVIR SODIUM TIVICAY	204790 Product 204790/001	TABLET · ORAL EQ 50MG BASE FDA marketing: RX	2028 DEEP_REVIEW FINAL	2
DOLUTEGRAVIR SODIUM TIVICAY	204790 Product 204790/002	TABLET · ORAL EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2024 DISQUALIFIED FINAL	2
DOLUTEGRAVIR SODIUM TIVICAY	204790 Product 204790/003	TABLET · ORAL EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2024 DISQUALIFIED FINAL	2
DOLUTEGRAVIR SODIUM TIVICAY PD	213983 Product 213983/001	TABLET, FOR SUSPENSION · ORAL EQ 5MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	2
DOLUTEGRAVIR SODIUM; LAMIVUDINE DOVATO	211994 Product 211994/001	TABLET · ORAL EQ 50MG BASE;300MG FDA marketing: Prescription	2031 CANDIDATE FINAL	3
DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE JULUCA	210192 Product 210192/001	TABLET · ORAL EQ 50MG BASE;EQ 25MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	4
donanemab-azbt Kisunla	761248 Product 761248/001	Injection · Intravenous 350MG/20ML (17.5MG/ML) Single-Dose Vial FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	3
DONEPEZIL HYDROCHLORIDE ADLARITY	212304 Product 212304/001	SYSTEM · TRANSDERMAL 5MG/DAY FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	11
DONEPEZIL HYDROCHLORIDE ADLARITY	212304 Product 212304/002	SYSTEM · TRANSDERMAL 10MG/DAY FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	11
DONEPEZIL HYDROCHLORIDE ARICEPT	022568 Product 022568/001	TABLET · ORAL 23MG FDA marketing: Prescription	2013 EXISTING_GENERIC DISQUALIFIED	1
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	208359 Product 208359/001	CAPSULE, EXTENDED RELEASE · ORAL 10MG;14MG FDA marketing: Prescription	Master only	0
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	208359 Product 208359/002	CAPSULE, EXTENDED RELEASE · ORAL 10MG;28MG FDA marketing: Prescription	Master only	0
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE NAMZARIC	206439 Product 206439/001	CAPSULE, EXTENDED RELEASE · ORAL 10MG;14MG FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	2
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE NAMZARIC	206439 Product 206439/002	CAPSULE, EXTENDED RELEASE · ORAL 10MG;28MG FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	2
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE NAMZARIC	206439 Product 206439/003	CAPSULE, EXTENDED RELEASE · ORAL 10MG;7MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	2
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE NAMZARIC	206439 Product 206439/004	CAPSULE, EXTENDED RELEASE · ORAL 10MG;21MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	2
DONIDALORSEN SODIUM DAWNZERA (AUTOINJECTOR)	219407 Product 219407/001	SOLUTION · SUBCUTANEOUS EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) FDA marketing: Prescription	2035 CANDIDATE FINAL	5
DORAVIRINE PIFELTRO	210806 Product 210806/001	TABLET · ORAL 100MG FDA marketing: Prescription	Master only	1
DORAVIRINE; ISLATRAVIR IDVYNSO	216964 Product 216964/001	TABLET · ORAL 100MG;0.25MG FDA marketing: Prescription	2032 CANDIDATE FINAL	2
DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE DELSTRIGO	210807 Product 210807/001	TABLET · ORAL 100MG;300MG;300MG FDA marketing: Prescription	Master only	3
DORDAVIPRONE HYDROCHLORIDE MODEYSO	219876 Product 219876/001	CAPSULE · ORAL EQ 125MG BASE FDA marketing: Prescription	2037 CANDIDATE FINAL_CHECKING	7
DORIPENEM DORIBAX	022106 Product 022106/002	INJECTABLE · INTRAVENOUS 250MG/VIAL FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	2
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE COSOPT PF	202667 Product 202667/001	SOLUTION/DROPS · OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
dostarlimab-gxly Jemperli	761174 Product 761174/001	Injection · Intravenous 500MG/10ML (50MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	2
DOXECITINE; DOXRIBTIMINE KYGEVVI	219792 Product 219792/001	FOR SOLUTION · ORAL 2GM/PACKET;2GM/PACKET FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	2
DOXEPIN HYDROCHLORIDE SILENOR	022036 Product 022036/001	TABLET · ORAL EQ 3MG BASE FDA marketing: Prescription	2013 EXISTING_GENERIC DISQUALIFIED	16
DOXEPIN HYDROCHLORIDE SILENOR	022036 Product 022036/002	TABLET · ORAL EQ 6MG BASE FDA marketing: Prescription	2013 EXISTING_GENERIC DISQUALIFIED	16
DOXERCALCIFEROL DOXERCALCIFEROL	208614 Product 208614/001	INJECTABLE · INJECTION 4MCG/2ML (2MCG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
DOXERCALCIFEROL DOXERCALCIFEROL	208614 Product 208614/002	INJECTABLE · INJECTION 10MCG/5ML (2MCG/ML) FDA marketing: Discontinued	2018 DEEP_REVIEW PROVISIONAL	0
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE	050629 Product 050629/003	INJECTABLE · INJECTION 150MG/75ML FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	0
DOXYCYCLINE MONODOX	050641 Product 050641/004	CAPSULE · ORAL EQ 150MG BASE FDA marketing: Prescription	2005 EXISTING_GENERIC DISQUALIFIED	0
DOXYCYCLINE HYCLATE ACTICLATE	205931 Product 205931/001	TABLET · ORAL EQ 75MG BASE FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
DOXYCYCLINE HYCLATE ACTICLATE	205931 Product 205931/002	TABLET · ORAL EQ 150MG BASE FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
DOXYCYCLINE HYCLATE ACTICLATE CAP	208253 Product 208253/001	CAPSULE · ORAL EQ 75MG BASE FDA marketing: Discontinued	2018 DISCONTINUED FINAL	0
DOXYCYCLINE HYCLATE DORYX	050795 Product 050795/004	TABLET, DELAYED RELEASE · ORAL EQ 80MG BASE FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	1
DOXYCYCLINE HYCLATE DORYX	050795 Product 050795/005	TABLET, DELAYED RELEASE · ORAL EQ 200MG BASE FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	1
DOXYCYCLINE HYCLATE DORYX	050795 Product 050795/006	TABLET, DELAYED RELEASE · ORAL EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2014 DEEP_REVIEW FINAL_CHECKING	1
DOXYCYCLINE HYCLATE DORYX MPC	050795 Product 050795/007	TABLET, DELAYED RELEASE · ORAL EQ 60MG BASE FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	4
DOXYCYCLINE HYCLATE DORYX MPC	050795 Product 050795/008	TABLET, DELAYED RELEASE · ORAL EQ 120MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2023 DISCONTINUED FINAL	4
DOXYCYCLINE HYCLATE LYMEPAK	209844 Product 209844/001	TABLET · ORAL EQ 100MG BASE FDA marketing: Discontinued	DISCONTINUED FINAL	0
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE BONJESTA	209661 Product 209661/001	TABLET, EXTENDED RELEASE · ORAL 20MG;20MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	4
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE DICLEGIS	021876 Product 021876/001	TABLET, DELAYED RELEASE · ORAL 10MG;10MG FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
DRONABINOL SYNDROS	205525 Product 205525/001	SOLUTION · ORAL 5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2024 DISQUALIFIED FINAL	4
DROSPIRENONE DROSPIRENONE	216285 Product 216285/001	TABLET, CHEWABLE · ORAL 3.5MG FDA marketing: Discontinued	2023 DISCONTINUED FINAL	15
DROSPIRENONE SLYND	211367 Product 211367/001	TABLET · ORAL 4MG FDA marketing: RX	2031 CANDIDATE FINAL	15
DROSPIRENONE; ESTETROL NEXTSTELLIS	214154 Product 214154/001	TABLET · ORAL 3MG;14.2MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	7
DROSPIRENONE; ESTRADIOL ANGELIQ	021355 Product 021355/001	TABLET · ORAL 0.25MG;0.5MG FDA marketing: Prescription	2031 CANDIDATE FINAL_CHECKING	1
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM BEYAZ	022532 Product 022532/001	TABLET · ORAL 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	2
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM SAFYRAL	022574 Product 022574/001	TABLET · ORAL 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	2
DROXIDOPA NORTHERA	203202 Product 203202/001	CAPSULE · ORAL 100MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
DROXIDOPA NORTHERA	203202 Product 203202/002	CAPSULE · ORAL 200MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
DROXIDOPA NORTHERA	203202 Product 203202/003	CAPSULE · ORAL 300MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
dulaglutide Trulicity	125469 Product 125469/001	Injection · Subcutaneous 0.75MG/0.5ML Autoinjector FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	0
dulaglutide Trulicity	125469 Product 125469/002	Injection · Subcutaneous 1.5MG/0.5ML Autoinjector FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	0
dulaglutide Trulicity	125469 Product 125469/005	Injection · Subcutaneous 3MG/0.5ML Autoinjector FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	0
dulaglutide Trulicity	125469 Product 125469/006	Injection · Subcutaneous 4.5MG/0.5ML Autoinjector FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	0
DULOXETINE HYDROCHLORIDE CYMBALTA	021427 Product 021427/001	CAPSULE, DELAYED REL PELLETS · ORAL EQ 20MG BASE FDA marketing: Prescription	2013 EXISTING_GENERIC DISQUALIFIED	0
DULOXETINE HYDROCHLORIDE CYMBALTA	021427 Product 021427/002	CAPSULE, DELAYED REL PELLETS · ORAL EQ 30MG BASE FDA marketing: Prescription	2013 EXISTING_GENERIC DISQUALIFIED	0
DULOXETINE HYDROCHLORIDE CYMBALTA	021427 Product 021427/004	CAPSULE, DELAYED REL PELLETS · ORAL EQ 60MG BASE FDA marketing: Prescription	2013 EXISTING_GENERIC DISQUALIFIED	0
DULOXETINE HYDROCHLORIDE DRIZALMA SPRINKLE	212516 Product 212516/001	CAPSULE, DELAYED REL PELLETS · ORAL EQ 20MG BASE FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	5
DULOXETINE HYDROCHLORIDE DRIZALMA SPRINKLE	212516 Product 212516/002	CAPSULE, DELAYED REL PELLETS · ORAL EQ 30MG BASE FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	5
DULOXETINE HYDROCHLORIDE DRIZALMA SPRINKLE	212516 Product 212516/003	CAPSULE, DELAYED REL PELLETS · ORAL EQ 40MG BASE FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	5
DULOXETINE HYDROCHLORIDE DRIZALMA SPRINKLE	212516 Product 212516/004	CAPSULE, DELAYED REL PELLETS · ORAL EQ 60MG BASE FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	5
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE	219131 Product 219131/001	CAPSULE, DELAYED REL PELLETS · ORAL EQ 80MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	1
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE	219131 Product 219131/002	CAPSULE, DELAYED REL PELLETS · ORAL EQ 90MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	1
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE	219131 Product 219131/003	CAPSULE, DELAYED REL PELLETS · ORAL EQ 120MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	1
dupilumab Dupixent	761055 Product 761055/001	Injection · Subcutaneous 300MG/2ML Pre-Filled Syringe FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	0
DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM XACDURO (COPACKAGED)	216974 Product 216974/001	POWDER · INTRAVENOUS EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL FDA marketing: Prescription	2035 CANDIDATE FINAL	4
durvalumab Imfinzi	761069 Product 761069/001	Injection · Intravenous 500MG/10ML (50MG/ML) Single-Dose Vial FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	0
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE JALYN	022460 Product 022460/001	CAPSULE · ORAL 0.5MG;0.4MG FDA marketing: Prescription	2014 EXISTING_GENERIC DISQUALIFIED	0
DUVELISIB COPIKTRA	211155 Product 211155/001	CAPSULE · ORAL 15MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	6
DUVELISIB COPIKTRA	211155 Product 211155/002	CAPSULE · ORAL 25MG FDA marketing: Prescription	2035 CANDIDATE FINAL	6
ECONAZOLE NITRATE ECOZA	205175 Product 205175/001	AEROSOL, FOAM · TOPICAL 1% FDA marketing: Prescription	2016 DEEP_REVIEW FINAL_CHECKING	1
eculizumab-aagh Epysqli	761340 Product 761340/001	Injection · Intravenous 300MG/30ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	0
eculizumab-aeeb Bkemv	761333 Product 761333/001	Injection · Intravenous 300MG/30ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	0
EDARAVONE RADICAVA	209176 Product 209176/001	SOLUTION · INTRAVENOUS 30MG/100ML (0.3MG/ML) FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	0
EDARAVONE RADICAVA	209176 Product 209176/002	SOLUTION · INTRAVENOUS 60MG/100ML (0.6MG/ML) FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	0
EDARAVONE RADICAVA ORS	215446 Product 215446/001	SUSPENSION · ORAL 105MG/5ML FDA marketing: Prescription	2029 DEEP_REVIEW FINAL_CHECKING	12
EDOXABAN TOSYLATE SAVAYSA	206316 Product 206316/001	TABLET · ORAL EQ 15MG BASE FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	2
EDOXABAN TOSYLATE SAVAYSA	206316 Product 206316/002	TABLET · ORAL EQ 30MG BASE FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	2
EDOXABAN TOSYLATE SAVAYSA	206316 Product 206316/003	TABLET · ORAL EQ 60MG BASE FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	2
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	022343 Product 022343/001	TABLET · ORAL 600MG;300MG;300MG FDA marketing: Discontinued	DISCONTINUED FINAL	0
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	210649 Product 210649/001	TABLET · ORAL 400MG;300MG;300MG FDA marketing: Discontinued	DISCONTINUED FINAL	0
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE SYMFI	022142 Product 022142/001	TABLET · ORAL 600MG;300MG;300MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	0
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE SYMFI LO	208255 Product 208255/001	TABLET · ORAL 400MG;300MG;300MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	0
efbemalenograstim alfa-vuxw Ryzneuta	761134 Product 761134/001	Injection · Subcutaneous 20MG/ML Pre-Filled Syringe FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	1
efgartigimod alfa and hyaluronidase-qvfc Vyvgart Hytrulo	761304 Product 761304/001	Injection · Subcutaneous 1,008MG/5.6ML; 11,200UNITS/5.6ML (180MG/2,000UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	2
efgartigimod alfa-fcab Vyvgart	761195 Product 761195/001	Injection · Intravenous 400MG/20ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	3
EFINACONAZOLE JUBLIA	203567 Product 203567/001	SOLUTION · TOPICAL 10% FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	18
eflapegrastim-xnst Rolvedon	761148 Product 761148/001	Injection · Subcutaneous 13.2MG/0.6ML Pre-Filled Syringe FDA marketing: Prescription	2034 CANDIDATE FINAL_CHECKING	1
EFLORNITHINE HYDROCHLORIDE IWILFIN	215500 Product 215500/001	TABLET · ORAL EQ 192MG BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	1
ELACESTRANT HYDROCHLORIDE ORSERDU	217639 Product 217639/001	TABLET · ORAL EQ 86MG BASE FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	7
ELACESTRANT HYDROCHLORIDE ORSERDU	217639 Product 217639/002	TABLET · ORAL EQ 345MG BASE FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	7
ELAFIBRANOR IQIRVO	218860 Product 218860/001	TABLET · ORAL 80MG FDA marketing: Prescription	2037 DEEP_REVIEW FINAL_CHECKING	10
ELAGOLIX SODIUM ORILISSA	210450 Product 210450/001	TABLET · ORAL EQ 150MG BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	8
ELAGOLIX SODIUM ORILISSA	210450 Product 210450/002	TABLET · ORAL EQ 200MG BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	5
ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM ORIAHNN (COPACKAGED)	213388 Product 213388/001	CAPSULE · ORAL EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	7
ELAMIPRETIDE HYDROCHLORIDE FORZINITY	215244 Product 215244/001	SOLUTION · SUBCUTANEOUS EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) FDA marketing: Prescription	2034 CANDIDATE FINAL	6
elapegademase-lvlr Revcovi	761092 Product 761092/001	Injection · Intramuscular 2.4MG/1.5ML (1.6MG/ML) Single-Dose Vial FDA marketing: Prescription	2030 CANDIDATE FINAL	0
ELBASVIR; GRAZOPREVIR ZEPATIER	208261 Product 208261/001	TABLET · ORAL 50MG;100MG FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	2
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED)	212273 Product 212273/001	TABLET · ORAL 100MG,75MG,50MG; 150MG FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	30
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED)	212273 Product 212273/002	TABLET · ORAL 50MG,37.5MG,25MG; 75MG FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	30
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED)	217660 Product 217660/001	GRANULE · ORAL 80MG, 60MG, 40MG;59.5MG FDA marketing: Prescription	2037 CANDIDATE FINAL	33
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED)	217660 Product 217660/002	GRANULE · ORAL 100MG, 75MG, 50MG;75MG FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	34
ELIGLUSTAT TARTRATE CERDELGA	205494 Product 205494/001	CAPSULE · ORAL EQ 84MG BASE FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	5
ELINZANETANT LYNKUET	219469 Product 219469/001	CAPSULE · ORAL 60MG FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	6
elosulfase alfa Vimizim	125460 Product 125460/001	Injection · Intravenous 5MG/5ML (1MG/ML) Single-Dose Vial FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
elotuzumab Empliciti	761035 Product 761035/001	For Injection · Intravenous 300MG Single-Dose Vial FDA marketing: Prescription	2029 CANDIDATE FINAL	0
elotuzumab Empliciti	761035 Product 761035/002	For Injection · Intravenous 400MG Single-Dose Vial FDA marketing: Prescription	2029 CANDIDATE FINAL	0
ELRANATAMAB ELREXFIO	761345 Product 761345/001	SOLUTION · INJECTION 12MG FDA marketing: Prescription	Master only	0
ELTROMBOPAG CHOLINE ALVAIZ	216774 Product 216774/001	TABLET · ORAL EQ 9MG BASE FDA marketing: Prescription	Master only	1
ELTROMBOPAG CHOLINE ALVAIZ	216774 Product 216774/002	TABLET · ORAL EQ 18MG BASE FDA marketing: Prescription	Master only	1
ELTROMBOPAG CHOLINE ALVAIZ	216774 Product 216774/003	TABLET · ORAL EQ 36MG BASE FDA marketing: Prescription	Master only	1
ELTROMBOPAG CHOLINE ALVAIZ	216774 Product 216774/004	TABLET · ORAL EQ 54MG BASE FDA marketing: Prescription	Master only	1
ELTROMBOPAG OLAMINE PROMACTA	022291 Product 022291/004	TABLET · ORAL EQ 12.5MG ACID FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
ELTROMBOPAG OLAMINE PROMACTA	022291 Product 022291/005	TABLET · ORAL EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2019 DISQUALIFIED FINAL	1
ELTROMBOPAG OLAMINE PROMACTA KIT	207027 Product 207027/001	FOR SUSPENSION · ORAL EQ 25MG ACID/PACKET FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	1
ELTROMBOPAG OLAMINE PROMACTA KIT	207027 Product 207027/002	FOR SUSPENSION · ORAL EQ 12.5MG ACID/PACKET FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	1
ELUXADOLINE VIBERZI	206940 Product 206940/001	TABLET · ORAL 75MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	13
ELUXADOLINE VIBERZI	206940 Product 206940/002	TABLET · ORAL 100MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	13
ELVITEGRAVIR VITEKTA	203093 Product 203093/001	TABLET · ORAL 85MG FDA marketing: DISCONTINUED	2017 DISQUALIFIED FINAL	3
ELVITEGRAVIR VITEKTA	203093 Product 203093/002	TABLET · ORAL 150MG FDA marketing: DISCONTINUED	2017 DISQUALIFIED FINAL	3
emapalumab-lzsg Gamifant	761107 Product 761107/001	Injection · Intravenous 10MG/2ML (5MG/ML) Single-Dose Vial FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	0
emapalumab-lzsg Gamifant	761107 Product 761107/002	Injection · Intravenous 50MG/10ML (5MG/ML) Single-Dose Vial FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	0
emapalumab-lzsg Gamifant	761107 Product 761107/003	Injection · Intravenous 100MG/20ML (5MG/ML) Single-Dose Vial FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	0
emicizumab-kxwh Hemlibra	761083 Product 761083/001	Injection · Subcutaneous 30MG/ML Single-Dose Vial FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	0
emicizumab-kxwh Hemlibra	761083 Product 761083/002	Injection · Subcutaneous 60MG/0.4ML Single-Dose Vial FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	0
emicizumab-kxwh Hemlibra	761083 Product 761083/003	Injection · Subcutaneous 105MG/0.7ML Single-Dose Vial FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	0
emicizumab-kxwh Hemlibra	761083 Product 761083/004	Injection · Subcutaneous 150MG/ML Single-Dose Vial FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	0
EMPAGLIFLOZIN EMPAGLIFLOZIN	212330 Product 212330/001	TABLET · ORAL 10MG FDA marketing: Prescription	Master only	0
EMPAGLIFLOZIN EMPAGLIFLOZIN	212330 Product 212330/002	TABLET · ORAL 25MG FDA marketing: Prescription	Master only	0
EMPAGLIFLOZIN JARDIANCE	204629 Product 204629/001	TABLET · ORAL 10MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	15
EMPAGLIFLOZIN JARDIANCE	204629 Product 204629/002	TABLET · ORAL 25MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	13
EMPAGLIFLOZIN; LINAGLIPTIN GLYXAMBI	206073 Product 206073/001	TABLET · ORAL 10MG;5MG FDA marketing: RX	2034 DEEP_REVIEW FINAL	15
EMPAGLIFLOZIN; LINAGLIPTIN GLYXAMBI	206073 Product 206073/002	TABLET · ORAL 25MG;5MG FDA marketing: RX	2034 DEEP_REVIEW FINAL	15
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE TRIJARDY XR	212614 Product 212614/001	TABLET, EXTENDED RELEASE · ORAL 5MG;2.5MG;1GM FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	17
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE TRIJARDY XR	212614 Product 212614/002	TABLET, EXTENDED RELEASE · ORAL 10MG;5MG;1GM FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	17
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE TRIJARDY XR	212614 Product 212614/003	TABLET, EXTENDED RELEASE · ORAL 12.5MG;2.5MG;1GM FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	17
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE TRIJARDY XR	212614 Product 212614/004	TABLET, EXTENDED RELEASE · ORAL 25MG;5MG;1GM FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	16
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE SYNJARDY	206111 Product 206111/001	TABLET · ORAL 5MG;500MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	14
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE SYNJARDY	206111 Product 206111/002	TABLET · ORAL 5MG;1GM FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	14
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE SYNJARDY	206111 Product 206111/003	TABLET · ORAL 12.5MG;500MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	13
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE SYNJARDY	206111 Product 206111/004	TABLET · ORAL 12.5MG;1GM FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	13
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE SYNJARDY XR	208658 Product 208658/001	TABLET, EXTENDED RELEASE · ORAL 5MG;1GM FDA marketing: RX	2034 DEEP_REVIEW FINAL	14
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE SYNJARDY XR	208658 Product 208658/002	TABLET, EXTENDED RELEASE · ORAL 10MG;1GM FDA marketing: RX	2034 DEEP_REVIEW FINAL	14
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE SYNJARDY XR	208658 Product 208658/003	TABLET, EXTENDED RELEASE · ORAL 12.5MG;1GM FDA marketing: RX	2029 DEEP_REVIEW FINAL	13
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE SYNJARDY XR	208658 Product 208658/004	TABLET, EXTENDED RELEASE · ORAL 25MG;1GM FDA marketing: RX	2029 DEEP_REVIEW FINAL	13
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE ODEFSEY	208351 Product 208351/001	TABLET · ORAL 200MG;EQ 25MG BASE;EQ 25MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	2
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE COMPLERA	202123 Product 202123/001	TABLET · ORAL 200MG;EQ 25MG BASE;300MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE DESCOVY	208215 Product 208215/001	TABLET · ORAL 200MG;EQ 25MG BASE FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	6
EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE DESCOVY	208215 Product 208215/002	TABLET · ORAL 120MG;EQ 15MG BASE FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	3
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TRUVADA	021752 Product 021752/002	TABLET · ORAL 100MG;150MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TRUVADA	021752 Product 021752/003	TABLET · ORAL 133MG;200MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TRUVADA	021752 Product 021752/004	TABLET · ORAL 167MG;250MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
ENALAPRIL MALEATE EPANED	208686 Product 208686/001	SOLUTION · ORAL 1MG/ML FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	9
ENALAPRIL MALEATE EPANED KIT	204308 Product 204308/001	FOR SOLUTION · ORAL 1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2019 DISCONTINUED FINAL	4
ENASIDENIB MESYLATE IDHIFA	209606 Product 209606/001	TABLET · ORAL EQ 50MG BASE FDA marketing: Prescription	2034 CANDIDATE FINAL	6
ENASIDENIB MESYLATE IDHIFA	209606 Product 209606/002	TABLET · ORAL EQ 100MG BASE FDA marketing: Prescription	2034 CANDIDATE FINAL	6
ENCORAFENIB BRAFTOVI	210496 Product 210496/001	CAPSULE · ORAL 50MG FDA marketing: DISCONTINUED	2019 DISQUALIFIED FINAL	10
ENCORAFENIB BRAFTOVI	210496 Product 210496/002	CAPSULE · ORAL 75MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	13
enfortumab vedotin-ejfv Padcev	761137 Product 761137/001	For Injection · Intravenous 20MG Single-Dose Vial FDA marketing: Prescription	2033 CANDIDATE FINAL	0
enfortumab vedotin-ejfv Padcev	761137 Product 761137/002	For Injection · Intravenous 30MG Single-Dose Vial FDA marketing: Prescription	2033 CANDIDATE FINAL	0
ENLICITIDE DECANOATE LIPFENDRA	220848 Product 220848/001	TABLET · ORAL EQ 20MG BASE FDA marketing: Prescription	2040 CANDIDATE FINAL	1
ENSARTINIB HYDROCHLORIDE ENSACOVE	218171 Product 218171/001	CAPSULE · ORAL EQ 25MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	4
ENSARTINIB HYDROCHLORIDE ENSACOVE	218171 Product 218171/002	CAPSULE · ORAL EQ 100MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	4
ENSIFENTRINE OHTUVAYRE	217389 Product 217389/001	SUSPENSION · INHALATION 3MG/2.5ML FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	5
ENSITRELVIR XOCOVA	220442 Product 220442/001	TABLET · ORAL 125MG FDA marketing: Prescription	2042 CANDIDATE FINAL	3
ENTRECTINIB ROZLYTREK	212725 Product 212725/001	CAPSULE · ORAL 100MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	14
ENTRECTINIB ROZLYTREK	212725 Product 212725/002	CAPSULE · ORAL 200MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	14
ENTRECTINIB ROZLYTREK	218550 Product 218550/001	PELLETS · ORAL 50MG/PACKET FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	2
ENZALUTAMIDE XTANDI	203415 Product 203415/001	CAPSULE · ORAL 40MG FDA marketing: Prescription	2021 EXISTING_GENERIC COMPLETED	4
ENZALUTAMIDE XTANDI	213674 Product 213674/001	TABLET · ORAL 40MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	6
ENZALUTAMIDE XTANDI	213674 Product 213674/002	TABLET · ORAL 80MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	7
epcoritamab-bysp Epkinly	761324 Product 761324/001	Injection · Subcutaneous 4MG/0.8ML Single-Dose Vial FDA marketing: Prescription	2035 DEEP_REVIEW FINAL_CHECKING	2
epcoritamab-bysp Epkinly	761324 Product 761324/002	Injection · Subcutaneous 48MG/0.8ML Single-Dose Vial FDA marketing: Prescription	2035 DEEP_REVIEW FINAL_CHECKING	2
EPHEDRINE HYDROCHLORIDE REZIPRES	213536 Product 213536/001	SOLUTION · INTRAVENOUS 23.5MG/5ML (4.7MG/ML) FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	0
EPHEDRINE HYDROCHLORIDE REZIPRES	213536 Product 213536/002	SOLUTION · INTRAVENOUS 47MG/ML (47MG/ML) FDA marketing: Discontinued	2021 DISQUALIFIED FINAL	0
EPHEDRINE HYDROCHLORIDE REZIPRES	213536 Product 213536/003	SOLUTION · INTRAVENOUS 47MG/5ML (9.4MG/ML) FDA marketing: Discontinued	2021 DISQUALIFIED FINAL	0
EPHEDRINE HYDROCHLORIDE REZIPRES	213536 Product 213536/004	SOLUTION · INTRAVENOUS 47MG/10ML (4.7MG/ML) FDA marketing: Discontinued	2025 DISQUALIFIED FINAL	0
EPHEDRINE SULFATE AKOVAZ	208289 Product 208289/001	SOLUTION · INTRAVENOUS 50MG/ML (50MG/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
EPHEDRINE SULFATE AKOVAZ	208289 Product 208289/002	SOLUTION · INTRAVENOUS 25MG/5ML (5MG/ML) FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
EPHEDRINE SULFATE CORPHEDRA	208943 Product 208943/001	SOLUTION · INTRAVENOUS 50MG/ML (50MG/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
EPHEDRINE SULFATE EMERPHED	213407 Product 213407/001	SOLUTION · INTRAVENOUS 50MG/10ML (5MG/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	5
EPHEDRINE SULFATE EMERPHED	213407 Product 213407/002	SOLUTION · INTRAVENOUS 25MG/5ML (5MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	2
EPHEDRINE SULFATE EPHEDRINE SULFATE	208609 Product 208609/001	SOLUTION · INTRAVENOUS 50MG/ML (50MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
EPHEDRINE SULFATE EPHEDRINE SULFATE	213994 Product 213994/001	SOLUTION · INTRAVENOUS 50MG/10ML (5MG/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
EPHEDRINE SULFATE EPHEDRINE SULFATE	213994 Product 213994/002	SOLUTION · INTRAVENOUS 25MG/5ML (5MG/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	2
EPINEPHRINE ADRENALIN	204200 Product 204200/001	SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS EQ 1MG BASE/ML (EQ 1MG BASE/ML) FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	3
EPINEPHRINE ADRENALIN	204640 Product 204640/001	SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS EQ 30MG BASE/30ML (EQ 1MG BASE/ML) FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	4
EPINEPHRINE ADRENALIN	215875 Product 215875/001	SOLUTION · INTRAVENOUS 2MG/250ML (8MCG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	4
EPINEPHRINE ADRENALIN	215875 Product 215875/002	SOLUTION · INTRAVENOUS 4MG/250ML (16MCG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	4
EPINEPHRINE ADRENALIN	215875 Product 215875/003	SOLUTION · INTRAVENOUS 5MG/250ML (20MCG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	4
EPINEPHRINE ADRENALIN	215875 Product 215875/004	SOLUTION · INTRAVENOUS 8MG/250ML (32MCG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	4
EPINEPHRINE ADRENALIN	215875 Product 215875/005	SOLUTION · INTRAVENOUS 10MG/250ML (40MCG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	4
EPINEPHRINE AUVI-Q	201739 Product 201739/001	SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS EQ 0.3MG/DELIVERY FDA marketing: Prescription	2012 DEEP_REVIEW FINAL_CHECKING	6
EPINEPHRINE AUVI-Q	201739 Product 201739/002	SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS EQ 0.15MG/DELIVERY FDA marketing: Prescription	2012 DEEP_REVIEW FINAL	9
EPINEPHRINE AUVI-Q	201739 Product 201739/003	SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS EQ 0.1MG/DELIVERY FDA marketing: Prescription	2017 DEEP_REVIEW FINAL_CHECKING	9
EPINEPHRINE EPINEPHRINE	205029 Product 205029/001	SOLUTION · INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 1MG/ML (1MG/ML) FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
EPINEPHRINE EPINEPHRINE	205029 Product 205029/002	SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 10MG/10ML (1MG/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
EPINEPHRINE EPINEPHRINE	205029 Product 205029/003	SOLUTION · INTRAVENOUS 1MG/ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	0
EPINEPHRINE EPINEPHRINE	205029 Product 205029/004	SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 30MG/30ML (1MG/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
EPINEPHRINE EPINEPHRINE	205029 Product 205029/005	SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 1MG/ML (1MG/ML) FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	0
EPINEPHRINE EPINEPHRINE	209359 Product 209359/001	SOLUTION · INTRAVENOUS 1MG/10ML (0.1MG/ML) FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	0
EPINEPHRINE EPINEPHRINE	211363 Product 211363/001	SOLUTION · INTRAVENOUS 1MG/10ML (0.1MG/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
EPINEPHRINE EPINEPHRINE	215425 Product 215425/001	SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 30MG/30ML (1MG/ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	1
EPINEPHRINE EPINEPHRINE	219239 Product 219239/003	SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 1MG/ML (1MG/ML) FDA marketing: Prescription	Master only	0
EPINEPHRINE EPINEPHRINE	219832 Product 219832/001	SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS EQ 30MG BASE/30ML (EQ 1MG BASE/ML) FDA marketing: Prescription	Master only	0
EPINEPHRINE EPINEPHRINE	220626 Product 220626/001	SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 1MG/ML (1MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
EPINEPHRINE EPINEPHRINE	220626 Product 220626/002	SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 30MG/30ML (1MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
EPINEPHRINE EPINEPHRINE	220657 Product 220657/001	SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS EQ 1MG BASE/ML (EQ 1MG BASE/ML) FDA marketing: Prescription	Master only	0
EPINEPHRINE NEFFY	214697 Product 214697/001	SPRAY · NASAL 2MG/SPRAY FDA marketing: Prescription	2039 CANDIDATE FINAL_CHECKING	8
EPINEPHRINE NEFFY	214697 Product 214697/002	SPRAY · NASAL 1MG/SPRAY FDA marketing: Prescription	2039 CANDIDATE FINAL_CHECKING	8
EPINEPHRINE PRIMATENE MIST	205920 Product 205920/001	AEROSOL, METERED · INHALATION 0.125MG/INH FDA marketing: Over-the-counter	2018 EXCLUDED FINAL	1
EPINEPHRINE SYMJEPI	207534 Product 207534/001	SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS 0.3MG/0.3ML (0.3MG/0.3ML) FDA marketing: Prescription	2017 DEEP_REVIEW FINAL_CHECKING	1
EPINEPHRINE SYMJEPI	207534 Product 207534/002	SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS 0.15MG/0.3ML (0.15MG/0.3ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
EPINEPHRINE BITARTRATE EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	218475 Product 218475/001	SOLUTION · INTRAVENOUS EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	0
EPINEPHRINE BITARTRATE EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	218475 Product 218475/002	SOLUTION · INTRAVENOUS EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	1
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE FLAVALTA	216564 Product 216564/001	SOLUTION · INJECTION EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
EPLONTERSEN SODIUM WAINUA	217388 Product 217388/002	SOLUTION · SUBCUTANEOUS EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) FDA marketing: Prescription	2034 CANDIDATE FINAL	3
EPLONTERSEN SODIUM WAINUA (AUTOINJECTOR)	217388 Product 217388/001	SOLUTION · SUBCUTANEOUS EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) FDA marketing: Prescription	2034 CANDIDATE FINAL	4
epoetin alfa-epbx Retacrit	125545 Product 125545/001	Injection · Intravenous, Subcutaneous 2,000UNITS/ML Single-Dose Vial FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
epoetin alfa-epbx Retacrit	125545 Product 125545/002	Injection · Intravenous, Subcutaneous 3,000UNITS/ML Single-Dose Vial FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
epoetin alfa-epbx Retacrit	125545 Product 125545/003	Injection · Intravenous, Subcutaneous 4,000UNITS/ML Single-Dose Vial FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
epoetin alfa-epbx Retacrit	125545 Product 125545/004	Injection · Intravenous, Subcutaneous 10,000UNITS/ML Single-Dose Vial FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
epoetin alfa-epbx Retacrit	125545 Product 125545/005	Injection · Intravenous, Subcutaneous 40,000UNITS/ML Single-Dose Vial FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
EPOPROSTENOL SODIUM VELETRI	022260 Product 022260/002	INJECTABLE · INJECTION EQ 0.5MG BASE/VIAL FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	2
eptinezumab-jjmr Vyepti	761119 Product 761119/001	Injection · Intravenous 100MG/ML Single-Dose Vial FDA marketing: Prescription	2034 CANDIDATE FINAL	0
ERAVACYCLINE DIHYDROCHLORIDE XERAVA	211109 Product 211109/001	POWDER · INTRAVENOUS EQ 50MG BASE/VIAL FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	4
ERAVACYCLINE DIHYDROCHLORIDE XERAVA	211109 Product 211109/002	POWDER · INTRAVENOUS EQ 100MG BASE/VIAL FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	4
ERDAFITINIB BALVERSA	212018 Product 212018/001	TABLET · ORAL 3MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	9
ERDAFITINIB BALVERSA	212018 Product 212018/002	TABLET · ORAL 4MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	9
ERDAFITINIB BALVERSA	212018 Product 212018/003	TABLET · ORAL 5MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	9
erenumab-aooe Aimovig	761077 Product 761077/001	Injection · Subcutaneous 70MG/ML Autoinjector FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	0
ERIBULIN MESYLATE ERIBULIN MESYLATE	218930 Product 218930/001	SOLUTION · INTRAVENOUS 1MG/2ML (0.5MG/ML) FDA marketing: Prescription	Master only	0
ERIBULIN MESYLATE HALAVEN	201532 Product 201532/001	SOLUTION · INTRAVENOUS 1MG/2ML (0.5MG/ML) FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	1
ERTUGLIFLOZIN STEGLATRO	209803 Product 209803/001	TABLET · ORAL 5MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	1
ERTUGLIFLOZIN STEGLATRO	209803 Product 209803/002	TABLET · ORAL 15MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	1
ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE SEGLUROMET	209806 Product 209806/001	TABLET · ORAL 2.5MG;500MG FDA marketing: Prescription	Master only	3
ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE SEGLUROMET	209806 Product 209806/002	TABLET · ORAL 2.5MG;1GM FDA marketing: Prescription	Master only	3
ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE SEGLUROMET	209806 Product 209806/003	TABLET · ORAL 7.5MG;500MG FDA marketing: Prescription	Master only	3
ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE SEGLUROMET	209806 Product 209806/004	TABLET · ORAL 7.5MG;1GM FDA marketing: Prescription	Master only	3
ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE STEGLUJAN	209805 Product 209805/001	TABLET · ORAL 5MG;EQ 100MG BASE FDA marketing: Prescription	2031 CANDIDATE FINAL	4
ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE STEGLUJAN	209805 Product 209805/002	TABLET · ORAL 15MG;EQ 100MG BASE FDA marketing: Prescription	2031 CANDIDATE FINAL	4
ESCITALOPRAM OXALATE ESCITALOPRAM	219130 Product 219130/001	CAPSULE · ORAL EQ 15MG BASE FDA marketing: Prescription	2012 DEEP_REVIEW FINAL	2
ESKETAMINE HYDROCHLORIDE SPRAVATO	211243 Product 211243/001	SPRAY · NASAL EQ 28MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	7
ESLICARBAZEPINE ACETATE APTIOM	022416 Product 022416/001	TABLET · ORAL 200MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	7
ESLICARBAZEPINE ACETATE APTIOM	022416 Product 022416/002	TABLET · ORAL 400MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	7
ESLICARBAZEPINE ACETATE APTIOM	022416 Product 022416/003	TABLET · ORAL 600MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	7
ESLICARBAZEPINE ACETATE APTIOM	022416 Product 022416/004	TABLET · ORAL 800MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	7
ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER	205703 Product 205703/002	SOLUTION · INTRAVENOUS 2GM/100ML (20MG/ML) FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	2
ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER	205703 Product 205703/001	SOLUTION · INTRAVENOUS 2.5GM/250ML (10MG/ML) FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	2
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM	214278 Product 214278/001	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE · ORAL EQ 20MG BASE FDA marketing: Discontinued	2022 DISCONTINUED FINAL	2
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM	218687 Product 218687/001	FOR SUSPENSION, DELAYED RELEASE · ORAL EQ 20MG BASE/PACKET FDA marketing: Prescription	Master only	0
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM	218687 Product 218687/002	FOR SUSPENSION, DELAYED RELEASE · ORAL EQ 40MG BASE/PACKET FDA marketing: Prescription	Master only	0
ESOMEPRAZOLE MAGNESIUM NEXIUM	021957 Product 021957/003	FOR SUSPENSION, DELAYED RELEASE · ORAL EQ 2.5MG BASE/PACKET FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
ESOMEPRAZOLE MAGNESIUM NEXIUM	021957 Product 021957/004	FOR SUSPENSION, DELAYED RELEASE · ORAL EQ 5MG BASE/PACKET FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
ESOMEPRAZOLE MAGNESIUM NEXIUM 24HR	204655 Product 204655/001	CAPSULE, DELAYED RELEASE · ORAL EQ 20MG BASE FDA marketing: Over-the-counter	2014 EXCLUDED FINAL	0
ESOMEPRAZOLE MAGNESIUM NEXIUM 24HR	207920 Product 207920/001	TABLET, DELAYED RELEASE · ORAL EQ 20MG BASE FDA marketing: Over-the-counter	2015 EXCLUDED FINAL	0
ESOMEPRAZOLE MAGNESIUM; NAPROXEN VIMOVO	022511 Product 022511/001	TABLET, DELAYED RELEASE · ORAL EQ 20MG BASE;500MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	17
ESOMEPRAZOLE MAGNESIUM; NAPROXEN VIMOVO	022511 Product 022511/002	TABLET, DELAYED RELEASE · ORAL EQ 20MG BASE;375MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	16
ESOMEPRAZOLE STRONTIUM ESOMEPRAZOLE STRONTIUM	202342 Product 202342/001	CAPSULE, DELAYED RELEASE · ORAL 24.65MG FDA marketing: Discontinued	2020 WITHDRAWN FINAL	0
ESOMEPRAZOLE STRONTIUM ESOMEPRAZOLE STRONTIUM	202342 Product 202342/002	CAPSULE, DELAYED RELEASE · ORAL 49.3MG FDA marketing: Discontinued	2020 WITHDRAWN FINAL	0
ESTRADIOL DIVIGEL	022038 Product 022038/004	GEL · TRANSDERMAL 0.1% (0.75GM/PACKET) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
ESTRADIOL DIVIGEL	022038 Product 022038/005	GEL · TRANSDERMAL 0.1% (1.25GM/PACKET) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
ESTRADIOL IMVEXXY	208564 Product 208564/001	INSERT · VAGINAL 0.004MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	19
ESTRADIOL IMVEXXY	208564 Product 208564/002	INSERT · VAGINAL 0.01MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	20
ESTRADIOL MINIVELLE	203752 Product 203752/001	FILM, EXTENDED RELEASE · TRANSDERMAL 0.0375MG/24HR FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	3
ESTRADIOL MINIVELLE	203752 Product 203752/002	FILM, EXTENDED RELEASE · TRANSDERMAL 0.075MG/24HR FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	3
ESTRADIOL MINIVELLE	203752 Product 203752/003	FILM, EXTENDED RELEASE · TRANSDERMAL 0.05MG/24HR FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	3
ESTRADIOL MINIVELLE	203752 Product 203752/004	FILM, EXTENDED RELEASE · TRANSDERMAL 0.1MG/24HR FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	3
ESTRADIOL MINIVELLE	203752 Product 203752/005	FILM, EXTENDED RELEASE · TRANSDERMAL 0.025MG/24HR FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	4
ESTRADIOL; LEVONORGESTREL ESTRADIOL AND LEVONORGESTREL	220407 Product 220407/001	FILM, EXTENDED RELEASE · TRANSDERMAL 0.045MG/24HR;0.015MG/24HR FDA marketing: Prescription	Master only	0
ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX MYFEMBREE	214846 Product 214846/001	TABLET · ORAL 1MG;0.5MG;40MG FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	8
ESTRADIOL; PROGESTERONE BIJUVA	210132 Product 210132/001	CAPSULE · ORAL 1MG;100MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	22
ESTRADIOL; PROGESTERONE BIJUVA	210132 Product 210132/002	CAPSULE · ORAL 0.5MG;100MG FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	17
etanercept-szzs Erelzi	761042 Product 761042/001	Injection · Subcutaneous 25MG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2023 DISCONTINUED FINAL	0
etanercept-szzs Erelzi	761042 Product 761042/002	Injection · Subcutaneous 50MG/ML Pre-Filled Syringe FDA marketing: Prescription	2023 DISCONTINUED FINAL	0
etanercept-ykro Eticovo	761066 Product 761066/002	Injection · Subcutaneous 25MG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2021 DISCONTINUED FINAL	0
ETANERCEPT-YKRO ETICOVO	761066 Product 761066/002	INJECTABLE · INJECTION 50MG/1ML FDA marketing: Prescription	Master only	0
ETELCALCETIDE PARSABIV	208325 Product 208325/001	SOLUTION · INTRAVENOUS 2.5MG/0.5ML (2.5MG/0.5ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	8
ETELCALCETIDE PARSABIV	208325 Product 208325/002	SOLUTION · INTRAVENOUS 5MG/ML (5MG/ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	8
ETELCALCETIDE PARSABIV	208325 Product 208325/003	SOLUTION · INTRAVENOUS 10MG/2ML (5MG/ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	8
ETEPLIRSEN EXONDYS 51	206488 Product 206488/001	SOLUTION · INTRAVENOUS 100MG/2ML (50MG/ML) FDA marketing: Prescription	2029 DEEP_REVIEW FINAL_CHECKING	5
ETEPLIRSEN EXONDYS 51	206488 Product 206488/002	SOLUTION · INTRAVENOUS 500MG/10ML (50MG/ML) FDA marketing: Prescription	2029 DEEP_REVIEW FINAL_CHECKING	5
ETHINYL ESTRADIOL; LEVONORGESTREL BALCOLTRA	208612 Product 208612/001	TABLET · ORAL 0.02MG;0.1MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	1
ETHINYL ESTRADIOL; LEVONORGESTREL QUARTETTE	204061 Product 204061/001	TABLET · ORAL 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	1
ETHINYL ESTRADIOL; LEVONORGESTREL TWIRLA	204017 Product 204017/001	SYSTEM · TRANSDERMAL 0.01MG/24HR;0.04MG/24HR FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	3
ETHINYL ESTRADIOL; LEVONORGESTREL TYBLUME	209405 Product 209405/001	TABLET · ORAL 0.02MG;0.1MG FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	0
ETHINYL ESTRADIOL; NORELGESTROMIN GWYN LO	219990 Product 219990/001	SYSTEM · TRANSDERMAL 0.02MG/24HR;0.22MG/24HR FDA marketing: Prescription	2029 CANDIDATE FINAL	0
ETHINYL ESTRADIOL; NORETHINDRONE NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	022573 Product 022573/001	TABLET, CHEWABLE · ORAL 0.025MG;0.8MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	2
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE FEMLYV	218718 Product 218718/001	TABLET, ORALLY DISINTEGRATING · ORAL 0.02MG;1MG FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	1
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE LO LOESTRIN FE	022501 Product 022501/001	TABLET · ORAL 0.01MG,0.01MG;1MG,N/A FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	1
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE LO MINASTRIN FE	204654 Product 204654/001	TABLET, CHEWABLE, TABLET · ORAL 0.01MG,0.01MG,N/A;1MG,N/A,N/A FDA marketing: Discontinued	2018 DISCONTINUED FINAL	1
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MINASTRIN 24 FE	203667 Product 203667/001	TABLET · ORAL 0.02MG;1MG FDA marketing: Discontinued	2024 WITHDRAWN FINAL	2
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TAYTULLA	204426 Product 204426/001	CAPSULE · ORAL 0.02MG;1MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	0
ETHINYL ESTRADIOL; NORGESTIMATE NORGESTIMATE AND ETHINYL ESTRADIOL	220876 Product 220876/001	TABLET · ORAL-28 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG FDA marketing: Prescription	Master only	0
ETHINYL ESTRADIOL; SEGESTERONE ACETATE ANNOVERA	209627 Product 209627/001	RING · VAGINAL 0.013MG/24HR;0.15MG/24HR FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	9
ETONOGESTREL NEXPLANON	021529 Product 021529/002	IMPLANT · IMPLANTATION 68MG/IMPLANT FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	4
ETOPOSIDE AVOPEF	220200 Product 220200/001	SOLUTION · INTRAVENOUS 100MG/5ML (20MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
ETOPOSIDE AVOPEF	220200 Product 220200/002	SOLUTION · INTRAVENOUS 500MG/25ML (20MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
ETRASIMOD ARGININE VELSIPITY	216956 Product 216956/001	TABLET · ORAL EQ 2MG BASE FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	9
ETRAVIRINE INTELENCE	022187 Product 022187/002	TABLET · ORAL 200MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
ETRAVIRINE INTELENCE	022187 Product 022187/003	TABLET · ORAL 25MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	0
ETRIPAMIL CARDAMYST	218571 Product 218571/001	SPRAY · NASAL 70MG FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	6
EVEROLIMUS AFINITOR	022334 Product 022334/003	TABLET · ORAL 2.5MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	2
EVEROLIMUS AFINITOR	022334 Product 022334/004	TABLET · ORAL 7.5MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	2
EVEROLIMUS AFINITOR DISPERZ	203985 Product 203985/001	TABLET, FOR SUSPENSION · ORAL 2MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	0
EVEROLIMUS AFINITOR DISPERZ	203985 Product 203985/002	TABLET, FOR SUSPENSION · ORAL 3MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	0
EVEROLIMUS AFINITOR DISPERZ	203985 Product 203985/003	TABLET, FOR SUSPENSION · ORAL 5MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	0
EVEROLIMUS EVEROLIMUS	220597 Product 220597/001	TABLET, FOR SUSPENSION · ORAL 2MG FDA marketing: Prescription	Master only	0
EVEROLIMUS EVEROLIMUS	220597 Product 220597/002	TABLET, FOR SUSPENSION · ORAL 3MG FDA marketing: Prescription	Master only	0
EVEROLIMUS EVEROLIMUS	220597 Product 220597/003	TABLET, FOR SUSPENSION · ORAL 5MG FDA marketing: Prescription	Master only	0
EVEROLIMUS ZORTRESS	021560 Product 021560/001	TABLET · ORAL 0.25MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
EVEROLIMUS ZORTRESS	021560 Product 021560/002	TABLET · ORAL 0.5MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
EVEROLIMUS ZORTRESS	021560 Product 021560/003	TABLET · ORAL 0.75MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
EVEROLIMUS ZORTRESS	021560 Product 021560/004	TABLET · ORAL 1MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
evinacumab-dgnb Evkeeza	761181 Product 761181/001	Injection · Intravenous 345MG/2.3ML (150MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	1
evinacumab-dgnb Evkeeza	761181 Product 761181/002	Injection · Intravenous 1,200MG/8ML (150MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	1
evolocumab Repatha	125522 Product 125522/001	Injection · Subcutaneous 140MG/ML Pre-Filled Syringe FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	0
EXENATIDE SYNTHETIC BYDUREON	022200 Product 022200/001	FOR SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS 2MG/VIAL FDA marketing: DISCONTINUED	2021 DISQUALIFIED FINAL	6
EXENATIDE SYNTHETIC BYDUREON BCISE	209210 Product 209210/001	SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	7
EXENATIDE SYNTHETIC BYDUREON PEN	022200 Product 022200/002	FOR SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS 2MG FDA marketing: DISCONTINUED	2021 DISQUALIFIED FINAL	6
EZETIMIBE; ROSUVASTATIN CALCIUM ROSZET	213072 Product 213072/001	TABLET · ORAL 10MG;EQ 5MG BASE FDA marketing: Discontinued	2022 DISCONTINUED FINAL	2
EZETIMIBE; ROSUVASTATIN CALCIUM ROSZET	213072 Product 213072/002	TABLET · ORAL 10MG;EQ 10MG BASE FDA marketing: Discontinued	2022 DISCONTINUED FINAL	2
EZETIMIBE; ROSUVASTATIN CALCIUM ROSZET	213072 Product 213072/003	TABLET · ORAL 10MG;EQ 20MG BASE FDA marketing: Discontinued	2022 DISCONTINUED FINAL	2
EZETIMIBE; ROSUVASTATIN CALCIUM ROSZET	213072 Product 213072/004	TABLET · ORAL 10MG;EQ 40MG BASE FDA marketing: Discontinued	2022 DISCONTINUED FINAL	2
EZOGABINE POTIGA	022345 Product 022345/001	TABLET · ORAL 50MG FDA marketing: Discontinued	2017 DISCONTINUED FINAL	0
EZOGABINE POTIGA	022345 Product 022345/002	TABLET · ORAL 200MG FDA marketing: Discontinued	2017 DISCONTINUED FINAL	0
EZOGABINE POTIGA	022345 Product 022345/003	TABLET · ORAL 300MG FDA marketing: Discontinued	2017 DISCONTINUED FINAL	0
EZOGABINE POTIGA	022345 Product 022345/004	TABLET · ORAL 400MG FDA marketing: Discontinued	2017 DISCONTINUED FINAL	0
fam-trastuzumab deruxtecan-nxki Enhertu	761139 Product 761139/001	For Injection · Intravenous 100MG Single-Dose Vial FDA marketing: Prescription	2033 CANDIDATE FINAL	0
FAMOTIDINE FAMOTIDINE	219935 Product 219935/001	SOLUTION · INTRAVENOUS 20MG/5ML (4MG/ML) FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	1
FAMOTIDINE FAMOTIDINE	219935 Product 219935/002	SOLUTION · INTRAVENOUS 40MG/10ML (4MG/ML) FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	1
FAMOTIDINE FAMOTIDINE	219935 Product 219935/003	SOLUTION · INTRAVENOUS 200MG/50ML (4MG/ML) FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	1
FAMOTIDINE; IBUPROFEN DUEXIS	022519 Product 022519/001	TABLET · ORAL 26.6MG;800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2024 DISCONTINUED FINAL	5
FANAPT FANAPT	022192 Product 022192/001	— 1MG	2016 EXISTING_GENERIC VERIFIED	0
FANAPT FANAPT	022192 Product 022192/002	— 2MG	2016 EXISTING_GENERIC VERIFIED	0
FANAPT FANAPT	022192 Product 022192/003	— 4MG	2016 EXISTING_GENERIC VERIFIED	0
FANAPT FANAPT	022192 Product 022192/004	— 6MG	2016 EXISTING_GENERIC VERIFIED	0
FANAPT FANAPT	022192 Product 022192/005	— 8MG	2016 EXISTING_GENERIC VERIFIED	0
FANAPT FANAPT	022192 Product 022192/006	— 10MG	2016 EXISTING_GENERIC VERIFIED	0
FANAPT FANAPT	022192 Product 022192/007	— 12MG	2016 EXISTING_GENERIC VERIFIED	0
faricimab-svoa Vabysmo	761235 Product 761235/001	Injection · Intravitreal 6MG/0.05ML (120MG/ML) Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	2
FEDRATINIB HYDROCHLORIDE INREBIC	212327 Product 212327/001	CAPSULE · ORAL EQ 100MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	5
FENFLURAMINE HYDROCHLORIDE FINTEPLA	212102 Product 212102/001	SOLUTION · ORAL EQ 2.2MG BASE/ML FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	14
FENOFIBRATE ANTARA (MICRONIZED)	021695 Product 021695/004	CAPSULE · ORAL 30MG FDA marketing: Discontinued	2022 DISCONTINUED FINAL	1
FENOFIBRATE ANTARA (MICRONIZED)	021695 Product 021695/005	CAPSULE · ORAL 90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
FENTANYL DURAGESIC-37	019813 Product 019813/006	FILM, EXTENDED RELEASE · TRANSDERMAL 37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2018 DEEP_REVIEW PROVISIONAL	0
FENTANYL SUBSYS	202788 Product 202788/001	SPRAY · SUBLINGUAL 0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2022 DISCONTINUED FINAL	10
FENTANYL SUBSYS	202788 Product 202788/002	SPRAY · SUBLINGUAL 0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2022 DISCONTINUED FINAL	9
FENTANYL SUBSYS	202788 Product 202788/003	SPRAY · SUBLINGUAL 0.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2022 DISCONTINUED FINAL	10
FENTANYL SUBSYS	202788 Product 202788/004	SPRAY · SUBLINGUAL 0.6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2022 DISCONTINUED FINAL	10
FENTANYL SUBSYS	202788 Product 202788/005	SPRAY · SUBLINGUAL 0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2022 DISCONTINUED FINAL	9
FENTANYL SUBSYS	202788 Product 202788/006	SPRAY · SUBLINGUAL 1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2022 DISCONTINUED FINAL	10
FENTANYL SUBSYS	202788 Product 202788/007	SPRAY · SUBLINGUAL 1.6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2022 DISCONTINUED FINAL	10
FENTANYL CITRATE ABSTRAL	022510 Product 022510/001	TABLET · SUBLINGUAL EQ 0.1MG BASE FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	3
FENTANYL CITRATE ABSTRAL	022510 Product 022510/002	TABLET · SUBLINGUAL EQ 0.2MG BASE FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	3
FENTANYL CITRATE ABSTRAL	022510 Product 022510/003	TABLET · SUBLINGUAL EQ 0.3MG BASE FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	3
FENTANYL CITRATE ABSTRAL	022510 Product 022510/004	TABLET · SUBLINGUAL EQ 0.4MG BASE FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	3
FENTANYL CITRATE ABSTRAL	022510 Product 022510/005	TABLET · SUBLINGUAL EQ 0.6MG BASE FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	3
FENTANYL CITRATE ABSTRAL	022510 Product 022510/006	TABLET · SUBLINGUAL EQ 0.8MG BASE FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	3
FENTANYL CITRATE FENTANYL CITRATE	019101 Product 019101/002	INJECTABLE · INJECTION EQ 0.025MG BASE/0.5ML FDA marketing: Discontinued	2023 DEEP_REVIEW FINAL	0
FENTANYL CITRATE FENTANYL CITRATE	215870 Product 215870/001	SOLUTION · INTRAVENOUS EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2023 DISQUALIFIED FINAL	0
FENTANYL CITRATE FENTANYL CITRATE	215870 Product 215870/002	SOLUTION · INTRAVENOUS EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2023 DISQUALIFIED FINAL	0
FENTANYL CITRATE LAZANDA	022569 Product 022569/001	SPRAY, METERED · NASAL EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2014 DEEP_REVIEW FINAL_CHECKING	1
FENTANYL CITRATE LAZANDA	022569 Product 022569/002	SPRAY, METERED · NASAL EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2014 DEEP_REVIEW FINAL_CHECKING	1
FENTANYL CITRATE LAZANDA	022569 Product 022569/003	SPRAY, METERED · NASAL EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2019 DISCONTINUED FINAL	1
FERRIC CARBOXYMALTOSE INJECTAFER	203565 Product 203565/001	SOLUTION · INTRAVENOUS 750MG IRON/15ML (50MG IRON/ML) FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	6
FERRIC CARBOXYMALTOSE INJECTAFER	203565 Product 203565/002	SOLUTION · INTRAVENOUS 500MG IRON/10ML (50MG IRON/ML) FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	6
FERRIC CARBOXYMALTOSE INJECTAFER	203565 Product 203565/003	SOLUTION · INTRAVENOUS 1GM IRON/20ML (50MG IRON/ML) FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	6
FERRIC CARBOXYMALTOSE INJECTAFER	203565 Product 203565/004	SOLUTION · INTRAVENOUS 100MG IRON/2ML (50MG IRON/ML) FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	6
FERRIC CITRATE AURYXIA	205874 Product 205874/001	TABLET · ORAL EQ 210MG IRON FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	3
FERRIC DERISOMALTOSE MONOFERRIC	208171 Product 208171/001	SOLUTION · INTRAVENOUS 100MG/ML (100MG/ML) FDA marketing: DISCONTINUED	2020 DISQUALIFIED FINAL	5
FERRIC DERISOMALTOSE MONOFERRIC	208171 Product 208171/002	SOLUTION · INTRAVENOUS 500MG/5ML (100MG/ML) FDA marketing: DISCONTINUED	2020 DISQUALIFIED FINAL	5
FERRIC DERISOMALTOSE MONOFERRIC	208171 Product 208171/003	SOLUTION · INTRAVENOUS 1GM/10ML (100MG/ML) FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	5
FERRIC MALTOL ACCRUFER	212320 Product 212320/001	CAPSULE · ORAL 30MG IRON FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	3
FERRIC OXYHYDROXIDE VELPHORO	205109 Product 205109/001	TABLET, CHEWABLE · ORAL EQ 500MG IRON FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	11
FERRIC PYROPHOSPHATE CITRATE TRIFERIC	206317 Product 206317/001	SOLUTION · INTRAVENOUS 27.2MG IRON/5ML (5.44MG IRON/ML) FDA marketing: Discontinued	2022 DISCONTINUED FINAL	1
FERRIC PYROPHOSPHATE CITRATE TRIFERIC	206317 Product 206317/002	SOLUTION · INTRAVENOUS 272MG IRON/50ML (5.44MG IRON/ML) FDA marketing: Discontinued	2018 DISCONTINUED FINAL	0
FERRIC PYROPHOSPHATE CITRATE TRIFERIC	208551 Product 208551/001	POWDER · INTRAVENOUS 272MG IRON/PACKET FDA marketing: Discontinued	2022 DISCONTINUED FINAL	2
FERRIC PYROPHOSPHATE CITRATE TRIFERIC AVNU	212860 Product 212860/001	SOLUTION · INTRAVENOUS 6.75MG IRON/4.5ML (1.5MG IRON/ML) FDA marketing: DISCONTINUED	2022 DISQUALIFIED FINAL	1
FERUMOXYTOL FERABRIGHT	219868 Product 219868/001	SOLUTION · INTRAVENOUS EQ 300MG IRON/10ML (EQ 30MG IRON/ML) FDA marketing: Prescription	2025 EXCLUDED FINAL	0
FERUMOXYTOL FERABRIGHT	219868 Product 219868/002	SOLUTION · INTRAVENOUS EQ 510MG IRON/17ML (EQ 30MG IRON/ML) FDA marketing: Prescription	2025 EXCLUDED FINAL	0
FEXINIDAZOLE FEXINIDAZOLE	214429 Product 214429/001	TABLET · ORAL 600MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	1
FEXOFENADINE HYDROCHLORIDE ALLEGRA ALLERGY	020872 Product 020872/007	TABLET · ORAL 60MG FDA marketing: Over-the-counter	2011 EXCLUDED FINAL	0
FEXOFENADINE HYDROCHLORIDE ALLEGRA ALLERGY	020872 Product 020872/010	TABLET · ORAL 180MG FDA marketing: Over-the-counter	2011 EXCLUDED FINAL	0
FEXOFENADINE HYDROCHLORIDE ALLEGRA HIVES	020872 Product 020872/008	TABLET · ORAL 60MG FDA marketing: Discontinued	2011 EXCLUDED FINAL	0
FEXOFENADINE HYDROCHLORIDE ALLEGRA HIVES	020872 Product 020872/009	TABLET · ORAL 180MG FDA marketing: Over-the-counter	2011 EXCLUDED FINAL	0
FEXOFENADINE HYDROCHLORIDE CHILDREN'S ALLEGRA ALLERGY	020872 Product 020872/005	TABLET · ORAL 30MG FDA marketing: Discontinued	2011 EXCLUDED FINAL	9
FEXOFENADINE HYDROCHLORIDE CHILDREN'S ALLEGRA ALLERGY	021909 Product 021909/002	TABLET, ORALLY DISINTEGRATING · ORAL 30MG FDA marketing: Discontinued	2011 EXCLUDED FINAL	0
FEXOFENADINE HYDROCHLORIDE CHILDREN'S ALLEGRA ALLERGY	201373 Product 201373/001	SUSPENSION · ORAL 30MG/5ML FDA marketing: Over-the-counter	2011 EXCLUDED FINAL	1
FEXOFENADINE HYDROCHLORIDE CHILDREN'S ALLEGRA HIVES	020872 Product 020872/006	TABLET · ORAL 30MG FDA marketing: Discontinued	2011 EXCLUDED FINAL	0
FEXOFENADINE HYDROCHLORIDE CHILDREN'S ALLEGRA HIVES	021909 Product 021909/003	TABLET, ORALLY DISINTEGRATING · ORAL 30MG FDA marketing: Discontinued	2011 EXCLUDED FINAL	7
FEXOFENADINE HYDROCHLORIDE CHILDREN'S ALLEGRA HIVES	201373 Product 201373/002	SUSPENSION · ORAL 30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2014 DEEP_REVIEW FINAL_CHECKING	1
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	020786 Product 020786/002	TABLET, EXTENDED RELEASE · ORAL 60MG;120MG FDA marketing: Over-the-counter	2011 EXCLUDED FINAL	0
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	021704 Product 021704/002	TABLET, EXTENDED RELEASE · ORAL 180MG;240MG FDA marketing: Over-the-counter	2011 EXCLUDED FINAL	0
FEZOLINETANT VEOZAH	216578 Product 216578/001	TABLET · ORAL 45MG FDA marketing: Prescription	2037 CANDIDATE FINAL	4
FIDAXOMICIN DIFICID	201699 Product 201699/001	TABLET · ORAL 200MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	4
FIDAXOMICIN DIFICID	213138 Product 213138/001	FOR SUSPENSION · ORAL 40MG/ML FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	5
FIDAXOMICIN FIDAXOMICIN	219737 Product 219737/001	TABLET · ORAL 200MG FDA marketing: Prescription	Master only	0
filgrastim-aafi Nivestym	761080 Product 761080/001	Injection · Intravenous, Subcutaneous 300MCG/ML Single-Dose Vial FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
filgrastim-aafi Nivestym	761080 Product 761080/002	Injection · Intravenous, Subcutaneous 480MCG/1.6ML Single-Dose Vial FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
filgrastim-aafi Nivestym	761080 Product 761080/003	Injection · Subcutaneous 300MCG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
filgrastim-aafi Nivestym	761080 Product 761080/004	Injection · Subcutaneous 480MCG/0.8ML Pre-Filled Syringe FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
filgrastim-ayow Releuko	761082 Product 761082/001	Injection · Intravenous, Subcutaneous 300MCG/ML Single-Dose Vial FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
filgrastim-ayow Releuko	761082 Product 761082/002	Injection · Intravenous, Subcutaneous 480MCG/1.6ML Single-Dose Vial FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
filgrastim-ayow Releuko	761082 Product 761082/003	Injection · Subcutaneous 300MCG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
filgrastim-ayow Releuko	761082 Product 761082/004	Injection · Subcutaneous 480MCG/0.8ML Pre-Filled Syringe FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
filgrastim-laha Filkri	761027 Product 761027/001	Injection · Intravenous, Subcutaneous 300MCG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
filgrastim-laha Filkri	761027 Product 761027/002	Injection · Intravenous, Subcutaneous 480MCG/0.8ML Pre-Filled Syringe FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
filgrastim-sndz Zarxio	125553 Product 125553/001	Injection · Intravenous, Subcutaneous 300MCG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
filgrastim-sndz Zarxio	125553 Product 125553/002	Injection · Intravenous, Subcutaneous 480MCG/0.8ML Pre-Filled Syringe FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
filgrastim-txid Nypozi	761126 Product 761126/001	Injection · Intravenous, Subcutaneous 300MCG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
filgrastim-txid Nypozi	761126 Product 761126/002	Injection · Intravenous, Subcutaneous 480MCG/0.8ML Pre-Filled Syringe FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
FINAFLOXACIN XTORO	206307 Product 206307/001	SUSPENSION/DROPS · OTIC 0.3% FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	4
FINASTERIDE; TADALAFIL ENTADFI	215423 Product 215423/001	CAPSULE · ORAL 5MG;5MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	0
FINERENONE KERENDIA	215341 Product 215341/001	TABLET · ORAL 10MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	2
FINERENONE KERENDIA	215341 Product 215341/002	TABLET · ORAL 20MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	2
FINERENONE KERENDIA	215341 Product 215341/003	TABLET · ORAL 40MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	2
FINGOLIMOD HYDROCHLORIDE GILENYA	022527 Product 022527/001	CAPSULE · ORAL EQ 0.5MG BASE FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	1
FINGOLIMOD HYDROCHLORIDE GILENYA	022527 Product 022527/002	CAPSULE · ORAL EQ 0.25MG BASE FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	1
FINGOLIMOD LAURYL SULFATE TASCENSO ODT	214962 Product 214962/001	TABLET, ORALLY DISINTEGRATING · ORAL EQ 0.25MG BASE FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	3
FINGOLIMOD LAURYL SULFATE TASCENSO ODT	214962 Product 214962/002	TABLET, ORALLY DISINTEGRATING · ORAL EQ 0.5MG BASE FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	3
FISH OIL TRIGLYCERIDES OMEGAVEN	210589 Product 210589/001	EMULSION · INTRAVENOUS 5GM/50ML (0.1GM/ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	1
FISH OIL TRIGLYCERIDES OMEGAVEN	210589 Product 210589/002	EMULSION · INTRAVENOUS 10GM/100ML (0.1GM/ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	1
FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL SMOFLIPID 20%	207648 Product 207648/001	EMULSION · INTRAVENOUS 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	0
FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL SMOFLIPID 20%	207648 Product 207648/002	EMULSION · INTRAVENOUS 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	0
FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL SMOFLIPID 20%	207648 Product 207648/003	EMULSION · INTRAVENOUS 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	0
FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL SMOFLIPID 20%	207648 Product 207648/004	EMULSION · INTRAVENOUS 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	0
FITUSIRAN SODIUM QFITLIA	219019 Product 219019/001	SOLUTION · SUBCUTANEOUS EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	4
FITUSIRAN SODIUM QFITLIA	219019 Product 219019/002	SOLUTION · SUBCUTANEOUS EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	4
FLIBANSERIN ADDYI	022526 Product 022526/001	TABLET · ORAL 100MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	1
FLORBETABEN F-18 NEURACEQ	204677 Product 204677/001	SOLUTION · INTRAVENOUS 1.4-135mCi/ML FDA marketing: Prescription	2014 EXCLUDED FINAL	2
FLORBETAPIR F-18 AMYVID	202008 Product 202008/001	SOLUTION · INTRAVENOUS 10ML (13.5-51mCi/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	2
FLORBETAPIR F-18 AMYVID	202008 Product 202008/002	SOLUTION · INTRAVENOUS 10-30ML (13.5-51mCi/ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	2
FLORBETAPIR F-18 AMYVID	202008 Product 202008/003	SOLUTION · INTRAVENOUS 10-50ML (13.5-51mCi/ML) FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	2
FLORBETAPIR F-18 AMYVID	202008 Product 202008/004	SOLUTION · INTRAVENOUS 10-100ML (13.5-51mCi/ML) FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	2
FLORETYROSINE F-18 PIXCLARA	218592 Product 218592/001	SOLUTION · INTRAVENOUS 5-300mCi/ML FDA marketing: Prescription	2026 EXCLUDED FINAL	0
FLORQUINITAU F-18 TAUKLARIFY	220496 Product 220496/001	SOLUTION · INTRAVENOUS 1-40mCi/ML FDA marketing: Prescription	2026 EXCLUDED FINAL	2
FLORTAUCIPIR F-18 TAUVID	212123 Product 212123/001	SOLUTION · INTRAVENOUS 30ML (8.1-51mCi/ML) FDA marketing: DISCONTINUED	2020 EXCLUDED FINAL	1
FLORTAUCIPIR F-18 TAUVID	212123 Product 212123/002	SOLUTION · INTRAVENOUS 50ML (8.1-51mCi/ML) FDA marketing: DISCONTINUED	2020 EXCLUDED FINAL	1
FLORTAUCIPIR F-18 TAUVID	212123 Product 212123/003	SOLUTION · INTRAVENOUS 50ML (8.1-100mCi/ML) FDA marketing: Prescription	2022 EXCLUDED FINAL	1
FLORTAUCIPIR F-18 TAUVID	212123 Product 212123/004	SOLUTION · INTRAVENOUS 100ML (8.1-100mCi/ML) FDA marketing: Prescription	2022 EXCLUDED FINAL	1
FLOTUFOLASTAT F-18 GALLIUM POSLUMA	216023 Product 216023/001	SOLUTION · INTRAVENOUS 25ML (8-158mCi/ML) FDA marketing: Prescription	2023 EXCLUDED FINAL	6
FLUCICLOVINE F-18 AXUMIN	208054 Product 208054/001	SOLUTION · INTRAVENOUS 9-221mCi/ML FDA marketing: Prescription	2016 EXCLUDED FINAL	8
FLUOCINOLONE ACETONIDE ILUVIEN	201923 Product 201923/001	IMPLANT · INTRAVITREAL 0.19MG FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	2
FLUOCINOLONE ACETONIDE YUTIQ	210331 Product 210331/001	IMPLANT · INTRAVITREAL 0.18MG FDA marketing: Discontinued	2026 DISCONTINUED FINAL	2
FLUORODOPA F-18 FLUORODOPA F18	200655 Product 200655/001	SOLUTION · INTRAVENOUS 1-40mCi/ML FDA marketing: Prescription	2019 EXCLUDED FINAL	0
FLUOROESTRADIOL F-18 CERIANNA	212155 Product 212155/001	SOLUTION · INTRAVENOUS 50ML (4-100mCi/ML) FDA marketing: Prescription	2020 EXCLUDED FINAL	0
FLUOROURACIL FAVLYXA	220201 Product 220201/001	SOLUTION · INTRAVENOUS 250MG/10ML (25MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
FLUOROURACIL FAVLYXA	220201 Product 220201/002	SOLUTION · INTRAVENOUS 2.5GM/100ML (25MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
FLUOROURACIL FLUOROURACIL	012209 Product 012209/002	INJECTABLE · INJECTION 2.5GM/50ML (50MG/ML) FDA marketing: Discontinued	2023 WITHDRAWN FINAL	0
FLUOROURACIL TOLAK	022259 Product 022259/001	CREAM · TOPICAL 4% FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	1
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE	202133 Product 202133/001	TABLET · ORAL EQ 60MG BASE FDA marketing: Discontinued	DISCONTINUED FINAL	0
FLURPIRIDAZ F-18 FLYRCADO	215168 Product 215168/001	SOLUTION · INTRAVENOUS 5-55mCi/ML FDA marketing: Prescription	2024 EXCLUDED FINAL	7
FLUTEMETAMOL F-18 VIZAMYL	203137 Product 203137/001	INJECTABLE · INTRAVENOUS 40.5mCi/10ML (4.05mCi/ML) FDA marketing: Discontinued	2025 DEEP_REVIEW FINAL_CHECKING	1
FLUTEMETAMOL F-18 VIZAMYL	203137 Product 203137/002	INJECTABLE · INTRAVENOUS 121.5mCi/30ML (4.05mCi/ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	1
FLUTICASONE FUROATE ARNUITY ELLIPTA	205625 Product 205625/001	POWDER · INHALATION 0.1MG/INH FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	9
FLUTICASONE FUROATE ARNUITY ELLIPTA	205625 Product 205625/002	POWDER · INHALATION 0.2MG/INH FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	9
FLUTICASONE FUROATE ARNUITY ELLIPTA	205625 Product 205625/003	POWDER · INHALATION 0.05MG/INH FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	1
FLUTICASONE FUROATE FLONASE SENSIMIST ALLERGY RELIEF	022051 Product 022051/002	SPRAY, METERED · NASAL 0.0275MG/SPRAY FDA marketing: Over-the-counter	2016 EXCLUDED FINAL	3
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA	209482 Product 209482/001	POWDER · INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	7
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA	209482 Product 209482/002	POWDER · INHALATION 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	6
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE BREO ELLIPTA	204275 Product 204275/001	POWDER · INHALATION 0.1MG/INH;EQ 0.025MG BASE/INH FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	4
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE BREO ELLIPTA	204275 Product 204275/002	POWDER · INHALATION 0.2MG/INH;EQ 0.025MG BASE/INH FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	4
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE BREO ELLIPTA	204275 Product 204275/003	POWDER · INHALATION 0.05MG/INH;EQ 0.025MG BASE/INH FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	4
FLUTICASONE PROPIONATE ARMONAIR DIGIHALER	208798 Product 208798/004	POWDER · INHALATION 0.055MG/INH FDA marketing: Discontinued	2024 DISCONTINUED FINAL	5
FLUTICASONE PROPIONATE ARMONAIR DIGIHALER	208798 Product 208798/005	POWDER · INHALATION 0.113MG/INH FDA marketing: Discontinued	2024 DISCONTINUED FINAL	5
FLUTICASONE PROPIONATE ARMONAIR DIGIHALER	208798 Product 208798/006	POWDER · INHALATION 0.232MG/INH FDA marketing: Discontinued	2024 DISCONTINUED FINAL	5
FLUTICASONE PROPIONATE ARMONAIR DIGIHALER	208798 Product 208798/008	POWDER · INHALATION 0.03MG/INH FDA marketing: Discontinued	2022 DISCONTINUED FINAL	5
FLUTICASONE PROPIONATE ARMONAIR RESPICLICK	208798 Product 208798/001	POWDER · INHALATION 0.055MG/INH FDA marketing: Discontinued	2019 DISCONTINUED FINAL	2
FLUTICASONE PROPIONATE ARMONAIR RESPICLICK	208798 Product 208798/002	POWDER · INHALATION 0.113MG/INH FDA marketing: Discontinued	2019 DISCONTINUED FINAL	2
FLUTICASONE PROPIONATE ARMONAIR RESPICLICK	208798 Product 208798/003	POWDER · INHALATION 0.232MG/INH FDA marketing: Discontinued	2019 DISCONTINUED FINAL	2
FLUTICASONE PROPIONATE ARMONAIR RESPICLICK	208798 Product 208798/007	POWDER · INHALATION 0.03MG/INH FDA marketing: Discontinued	2021 DISCONTINUED FINAL	2
FLUTICASONE PROPIONATE FLONASE ALLERGY RELIEF	205434 Product 205434/001	SPRAY, METERED · NASAL 0.05MG/SPRAY FDA marketing: Over-the-counter	2014 EXCLUDED FINAL	0
FLUTICASONE PROPIONATE XHANCE	209022 Product 209022/001	SPRAY, METERED · NASAL 0.093MG/SPRAY FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	3
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE AIRDUO DIGIHALER	208799 Product 208799/004	POWDER · INHALATION 0.055MG/INH;EQ 0.014MG BASE/INH FDA marketing: Discontinued	2024 DISCONTINUED FINAL	7
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE AIRDUO DIGIHALER	208799 Product 208799/005	POWDER · INHALATION 0.113MG/INH;EQ 0.014MG BASE/INH FDA marketing: Discontinued	2024 DISCONTINUED FINAL	6
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE AIRDUO DIGIHALER	208799 Product 208799/006	POWDER · INHALATION 0.232MG/INH;EQ 0.014MG BASE/INH FDA marketing: Discontinued	2024 DISCONTINUED FINAL	6
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE AIRDUO RESPICLICK	208799 Product 208799/001	POWDER · INHALATION 0.055MG/INH;EQ 0.014MG BASE/INH FDA marketing: Prescription	2020 DEEP_REVIEW FINAL_CHECKING	4
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE AIRDUO RESPICLICK	208799 Product 208799/002	POWDER · INHALATION 0.113MG/INH;EQ 0.014MG BASE/INH FDA marketing: Prescription	2020 DEEP_REVIEW FINAL_CHECKING	3
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE AIRDUO RESPICLICK	208799 Product 208799/003	POWDER · INHALATION 0.232MG/INH;EQ 0.014MG BASE/INH FDA marketing: Prescription	2020 DEEP_REVIEW FINAL_CHECKING	3
FOLIC ACID QUIOFIC	216395 Product 216395/001	SOLUTION · ORAL 0.2MG/ML FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
FORMOTEROL FUMARATE; GLYCOPYRROLATE BEVESPI AEROSPHERE	208294 Product 208294/001	AEROSOL, METERED · INHALATION 0.0048MG/INH;0.0090MG/INH FDA marketing: Prescription	2019 DEEP_REVIEW FINAL_CHECKING	7
FORMOTEROL FUMARATE; MOMETASONE FUROATE DULERA	022518 Product 022518/001	AEROSOL, METERED · INHALATION 0.005MG/INH;0.1MG/INH FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	6
FORMOTEROL FUMARATE; MOMETASONE FUROATE DULERA	022518 Product 022518/002	AEROSOL, METERED · INHALATION 0.005MG/INH;0.2MG/INH FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	6
FORMOTEROL FUMARATE; MOMETASONE FUROATE DULERA	022518 Product 022518/003	AEROSOL, METERED · INHALATION 0.005MG/INH;0.05MG/INH FDA marketing: Prescription	2023 CANDIDATE FINAL	0
FOSAPREPITANT DIMEGLUMINE EMEND	022023 Product 022023/002	POWDER · INTRAVENOUS EQ 150MG BASE/VIAL FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
FOSAPREPITANT DIMEGLUMINE FOCINVEZ	216686 Product 216686/001	SOLUTION · INTRAVENOUS EQ 150MG BASE/50ML (EQ 3MG BASE/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	2
FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE	210064 Product 210064/001	POWDER · INTRAVENOUS EQ 150MG BASE/VIAL FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	0
FOSAPREPITANT DIMEGLUMINE NAVITRUX	220436 Product 220436/001	POWDER · INTRAVENOUS EQ 150MG BASE/VIAL FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
FOSCARBIDOPA; FOSLEVODOPA VYALEV	216962 Product 216962/001	SOLUTION · SUBCUTANEOUS 120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML) FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	4
FOSDENOPTERIN HYDROBROMIDE NULIBRY	214018 Product 214018/001	POWDER · INTRAVENOUS EQ 9.5MG BASE/VIAL FDA marketing: Prescription	2029 CANDIDATE FINAL_CHECKING	1
FOSFOMYCIN DISODIUM CONTEPO	212271 Product 212271/001	POWDER · INTRAVENOUS EQ 6GM BASE/VIAL FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	4
FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE AKYNZEO	210493 Product 210493/001	POWDER · INTRAVENOUS EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL FDA marketing: DISCONTINUED	2023 DISQUALIFIED FINAL	12
FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE AKYNZEO	210493 Product 210493/002	SOLUTION · INTRAVENOUS EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	12
FOSPHENYTOIN SODIUM SESQUIENT	210864 Product 210864/001	SOLUTION · INTRAVENOUS EQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML) FDA marketing: Discontinued	2025 DISCONTINUED FINAL	5
FOSPHENYTOIN SODIUM SESQUIENT	210864 Product 210864/002	SOLUTION · INTRAVENOUS EQ 500MG PHENYTOIN NA/10ML (EQ 50MG PHENYTOIN NA/ML) FDA marketing: Discontinued	2025 DISCONTINUED FINAL	5
FOSTAMATINIB DISODIUM TAVALISSE	209299 Product 209299/001	TABLET · ORAL EQ 100MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	14
FOSTAMATINIB DISODIUM TAVALISSE	209299 Product 209299/002	TABLET · ORAL EQ 150MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	14
FOSTEMSAVIR TROMETHAMINE RUKOBIA	212950 Product 212950/001	TABLET, EXTENDED RELEASE · ORAL EQ 600MG BASE FDA marketing: Prescription	2029 CANDIDATE FINAL	2
fremanezumab-vfrm Ajovy	761089 Product 761089/001	Injection · Subcutaneous 225MG/1.5ML Pre-Filled Syringe FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	0
FRUQUINTINIB FRUZAQLA	217564 Product 217564/001	CAPSULE · ORAL 1MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	4
FRUQUINTINIB FRUZAQLA	217564 Product 217564/002	CAPSULE · ORAL 5MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	4
FULVESTRANT CLIGAVYX	210063 Product 210063/001	SOLUTION · INTRAMUSCULAR 250MG/5ML (50MG/ML) FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	0
FULVESTRANT FULVESTRANT	210326 Product 210326/001	SOLUTION · INTRAMUSCULAR 250MG/5ML (50MG/ML) FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	3
FUROSEMIDE FUROSCIX	209988 Product 209988/001	SOLUTION · SUBCUTANEOUS 80MG/10ML (8MG/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	4
FUROSEMIDE FUROSCIX READYFLOW (AUTOINJECTOR)	209988 Product 209988/002	SOLUTION · SUBCUTANEOUS 80MG/ML (80MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	10
FUROSEMIDE LASIX ONYU	217294 Product 217294/001	SOLUTION · SUBCUTANEOUS 80MG/2.67ML (30MG/ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	3
FUTIBATINIB LYTGOBI	214801 Product 214801/001	TABLET · ORAL 4MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	3
FUTIBATINIB LYTGOBI	214801 Product 214801/002	TABLET · ORAL 16MG FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	3
GABAPENTIN GRALISE	022544 Product 022544/001	TABLET · ORAL 300MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
GABAPENTIN GRALISE	022544 Product 022544/002	TABLET · ORAL 600MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
GABAPENTIN GRALISE	022544 Product 022544/003	TABLET · ORAL 450MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
GABAPENTIN GRALISE	022544 Product 022544/004	TABLET · ORAL 750MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
GABAPENTIN GRALISE	022544 Product 022544/005	TABLET · ORAL 900MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
GABAPENTIN ENACARBIL HORIZANT	022399 Product 022399/001	TABLET, EXTENDED RELEASE · ORAL 600MG FDA marketing: Prescription	Master only	3
GABAPENTIN ENACARBIL HORIZANT	022399 Product 022399/002	TABLET, EXTENDED RELEASE · ORAL 300MG FDA marketing: Prescription	Master only	3
GADOBUTROL GADAVIST	201277 Product 201277/001	SOLUTION · INTRAVENOUS 4.5354GM/7.5ML (604.72MG/ML) FDA marketing: Prescription	2011 EXCLUDED FINAL	0
GADOBUTROL GADAVIST	201277 Product 201277/002	SOLUTION · INTRAVENOUS 6.0472GM/10ML (604.72MG/ML) FDA marketing: Prescription	2011 EXCLUDED FINAL	0
GADOBUTROL GADAVIST	201277 Product 201277/003	SOLUTION · INTRAVENOUS 9.0708GM/15ML (604.72MG/ML) FDA marketing: Prescription	2011 EXCLUDED FINAL	0
GADOBUTROL GADAVIST	201277 Product 201277/004	SOLUTION · INTRAVENOUS 18.1416GM/30ML (604.72MG/ML) FDA marketing: Prescription	2011 EXCLUDED FINAL	0
GADOBUTROL GADAVIST	201277 Product 201277/005	SOLUTION · INTRAVENOUS 39.3068GM/65ML (604.72MG/ML) FDA marketing: Prescription	2011 EXCLUDED FINAL	0
GADOBUTROL GADAVIST	201277 Product 201277/006	SOLUTION · INTRAVENOUS 1.20944GM/2ML (604.72MG/ML) FDA marketing: Prescription	2013 EXCLUDED FINAL	0
GADOPICLENOL ELUCIREM	216986 Product 216986/001	SOLUTION · INTRAVENOUS 1.4553GM/3ML (485.1MG/ML) FDA marketing: Prescription	2022 EXCLUDED FINAL	4
GADOPICLENOL ELUCIREM	216986 Product 216986/002	SOLUTION · INTRAVENOUS 3.63825GM/7.5ML (485.1MG/ML) FDA marketing: Prescription	2022 EXCLUDED FINAL	4
GADOPICLENOL ELUCIREM	216986 Product 216986/003	SOLUTION · INTRAVENOUS 4.851GM/10ML (485.1MG/ML) FDA marketing: Prescription	2022 EXCLUDED FINAL	4
GADOPICLENOL ELUCIREM	216986 Product 216986/004	SOLUTION · INTRAVENOUS 7.2765GM/15ML (485.1MG/ML) FDA marketing: Prescription	2022 EXCLUDED FINAL	4
GADOPICLENOL ELUCIREM	216986 Product 216986/005	SOLUTION · INTRAVENOUS 14.553GM/30ML (485.1MG/ML) FDA marketing: Prescription	2022 EXCLUDED FINAL	4
GADOPICLENOL ELUCIREM	216986 Product 216986/006	SOLUTION · INTRAVENOUS 24.255GM/50ML (485.1MG/ML) FDA marketing: Prescription	2022 EXCLUDED FINAL	4
GADOPICLENOL ELUCIREM	216986 Product 216986/007	SOLUTION · INTRAVENOUS 48.51GM/100ML (485.1MG/ML) FDA marketing: Prescription	2022 EXCLUDED FINAL	4
GADOQUATRANE AMBELVIST	219627 Product 219627/001	SOLUTION · INTRAVENOUS 0.5158GM/2ML (257.9MG/ML) FDA marketing: Prescription	2026 EXCLUDED FINAL	6
GADOQUATRANE AMBELVIST	219627 Product 219627/002	SOLUTION · INTRAVENOUS 1.93425GM/7.5ML (257.9MG/ML) FDA marketing: Prescription	2026 EXCLUDED FINAL	6
GADOQUATRANE AMBELVIST	219627 Product 219627/003	SOLUTION · INTRAVENOUS 2.579GM/10ML (257.9MG/ML) FDA marketing: Prescription	2026 EXCLUDED FINAL	6
GADOQUATRANE AMBELVIST	219627 Product 219627/004	SOLUTION · INTRAVENOUS 3.8685GM/15ML (257.9MG/ML) FDA marketing: Prescription	2026 EXCLUDED FINAL	6
GADOQUATRANE AMBELVIST	219627 Product 219627/005	SOLUTION · INTRAVENOUS 7.737GM/30ML (257.9MG/ML) FDA marketing: Prescription	2026 EXCLUDED FINAL	6
GADOQUATRANE AMBELVIST	219627 Product 219627/006	SOLUTION · INTRAVENOUS 16.7635GM/65ML (257.9MG/ML) FDA marketing: Prescription	2026 EXCLUDED FINAL	6
GADOTERATE MEGLUMINE DOTAREM	204781 Product 204781/001	SOLUTION · INTRAVENOUS 37.69GM/100ML (376.9MG/ML) FDA marketing: Prescription	2013 EXCLUDED FINAL	0
GADOTERATE MEGLUMINE DOTAREM	204781 Product 204781/002	SOLUTION · INTRAVENOUS 3.769GM/10ML (376.9MG/ML) FDA marketing: Prescription	2013 EXCLUDED FINAL	0
GADOTERATE MEGLUMINE DOTAREM	204781 Product 204781/003	SOLUTION · INTRAVENOUS 5.6535GM/15ML (376.9MG/ML) FDA marketing: Prescription	2013 EXCLUDED FINAL	0
GADOTERATE MEGLUMINE DOTAREM	204781 Product 204781/004	SOLUTION · INTRAVENOUS 7.538GM/20ML (376.9MG/ML) FDA marketing: Prescription	2013 EXCLUDED FINAL	0
GADOTERATE MEGLUMINE DOTAREM	204781 Product 204781/005	SOLUTION · INTRAVENOUS 1.8845GM/5ML (376.9MG/ML) FDA marketing: Prescription	2017 EXCLUDED FINAL	0
GADOXETATE DISODIUM EOVIST	022090 Product 022090/002	SOLUTION · INTRAVENOUS 2.72145GM/15ML (181.43MG/ML) FDA marketing: Prescription	2013 EXCLUDED FINAL	1
galcanezumab-gnlm Emgality	761063 Product 761063/001	Injection · Subcutaneous 120MG/ML Autoinjector FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	0
GALLIUM DOTATATE GA-68 NETSPOT	208547 Product 208547/001	POWDER · INTRAVENOUS 2.1-5.5mCi/ML FDA marketing: Prescription	2016 EXCLUDED FINAL	1
GALLIUM GA-68 EDOTREOTIDE GALLIUM GA 68 EDOTREOTIDE	210828 Product 210828/001	SOLUTION · INTRAVENOUS 0.5-4mCi/ML FDA marketing: Prescription	2019 EXCLUDED FINAL	0
GALLIUM GA-68 GOZETOTIDE GALLIUM GA 68 GOZETOTIDE	212642 Product 212642/001	SOLUTION · INTRAVENOUS 0.5-5mCi/mL FDA marketing: Prescription	2020 EXCLUDED FINAL	0
GALLIUM GA-68 GOZETOTIDE GALLIUM GA 68 GOZETOTIDE	212643 Product 212643/001	SOLUTION · INTRAVENOUS 0.5-5mCi/mL FDA marketing: Prescription	2020 EXCLUDED FINAL	0
GALLIUM GA-68 GOZETOTIDE GOZELLIX	219592 Product 219592/001	POWDER · INTRAVENOUS N/A FDA marketing: Prescription	2025 EXCLUDED FINAL	1
GALLIUM GA-68 GOZETOTIDE ILLUCCIX	214032 Product 214032/001	POWDER · INTRAVENOUS N/A FDA marketing: Prescription	2021 EXCLUDED FINAL	1
GALLIUM GA-68 GOZETOTIDE LOCAMETZ	215841 Product 215841/001	POWDER · INTRAVENOUS N/A FDA marketing: Prescription	2022 EXCLUDED FINAL	2
GANAXOLONE ZTALMY	215904 Product 215904/001	SUSPENSION · ORAL 50MG/ML FDA marketing: Prescription	2037 DEEP_REVIEW FINAL_CHECKING	11
GANCICLOVIR GANZYK-RTU	209347 Product 209347/001	SOLUTION · INTRAVENOUS 500MG/250ML (2MG/ML) FDA marketing: Discontinued	2025 DISCONTINUED FINAL	1
garadacimab-gxii Andembry	761367 Product 761367/001	Injection · Subcutaneous 200MG/1.2ML (167MG/ML) Autoinjector FDA marketing: Prescription	2037 CANDIDATE FINAL_CHECKING	2
garetosmab-grts Pasatru	761508 Product 761508/001	Injection · Intravenous 300MG/5ML (60MG/ML) Single-Dose Vial FDA marketing: Prescription	2038 DEEP_REVIEW FINAL_CHECKING	1
GATIFLOXACIN ZYMAXID	022548 Product 022548/001	SOLUTION/DROPS · OPHTHALMIC 0.5% FDA marketing: Prescription	2013 EXISTING_GENERIC DISQUALIFIED	0
GEDATOLISIB REVTORPYK	219908 Product 219908/001	POWDER · INTRAVENOUS 180MG/VIAL FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	2
GEFITINIB IRESSA	206995 Product 206995/001	TABLET · ORAL 250MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
GEMCITABINE HYDROCHLORIDE AVGEMSI	219920 Product 219920/001	SOLUTION · INTRAVENOUS EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) FDA marketing: Discontinued	2025 DISQUALIFIED FINAL	1
GEMCITABINE HYDROCHLORIDE AVGEMSI	219920 Product 219920/002	SOLUTION · INTRAVENOUS EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML) FDA marketing: Prescription	2010 CANDIDATE FINAL	1
GEMCITABINE HYDROCHLORIDE AVGEMSI	219920 Product 219920/003	SOLUTION · INTRAVENOUS EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) FDA marketing: Prescription	2010 CANDIDATE FINAL	1
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE	200795 Product 200795/001	INJECTABLE · INJECTION 200MG/5.26ML (38MG/ML) FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE	200795 Product 200795/002	INJECTABLE · INJECTION 1GM/26.3ML (38MG/ML) FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE	200795 Product 200795/003	INJECTABLE · INJECTION 2GM/52.6ML (38MG/ML) FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE	209604 Product 209604/001	SOLUTION · INTRAVENOUS 200MG/2ML (100MG/ML) FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE	209604 Product 209604/002	SOLUTION · INTRAVENOUS 1GM/10ML (100MG/ML) FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE	209604 Product 209604/003	SOLUTION · INTRAVENOUS 1.5GM/15ML (100MG/ML) FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE	209604 Product 209604/004	SOLUTION · INTRAVENOUS 2GM/20ML (100MG/ML) FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
GEMCITABINE HYDROCHLORIDE INFUGEM	208313 Product 208313/001	SOLUTION · INTRAVENOUS EQ 1200MG BASE/120ML (EQ 10MG BASE/ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
GEMCITABINE HYDROCHLORIDE INFUGEM	208313 Product 208313/002	SOLUTION · INTRAVENOUS EQ 1300MG BASE/130ML (EQ 10MG BASE/ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
GEMCITABINE HYDROCHLORIDE INFUGEM	208313 Product 208313/003	SOLUTION · INTRAVENOUS EQ 1400MG BASE/140ML (EQ 10MG BASE/ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
GEMCITABINE HYDROCHLORIDE INFUGEM	208313 Product 208313/004	SOLUTION · INTRAVENOUS EQ 1500MG BASE/150ML (EQ 10MG BASE/ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
GEMCITABINE HYDROCHLORIDE INFUGEM	208313 Product 208313/005	SOLUTION · INTRAVENOUS EQ 1600MG BASE/160ML (EQ 10MG BASE/ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
GEMCITABINE HYDROCHLORIDE INFUGEM	208313 Product 208313/006	SOLUTION · INTRAVENOUS EQ 1700MG BASE/170ML (EQ 10MG BASE/ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
GEMCITABINE HYDROCHLORIDE INFUGEM	208313 Product 208313/007	SOLUTION · INTRAVENOUS EQ 1800MG BASE/180ML (EQ 10MG BASE/ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
GEMCITABINE HYDROCHLORIDE INFUGEM	208313 Product 208313/008	SOLUTION · INTRAVENOUS EQ 1900MG BASE/190ML (EQ 10MG BASE/ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
GEMCITABINE HYDROCHLORIDE INFUGEM	208313 Product 208313/009	SOLUTION · INTRAVENOUS EQ 2000MG BASE/200ML (EQ 10MG BASE/ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
GEMCITABINE HYDROCHLORIDE INFUGEM	208313 Product 208313/010	SOLUTION · INTRAVENOUS EQ 2200MG BASE/220ML (EQ 10MG BASE/ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
GEMCITABINE HYDROCHLORIDE INLEXZO	219683 Product 219683/001	SYSTEM · INTRAVESICAL EQ 225MG BASE FDA marketing: Prescription	2038 CANDIDATE FINAL_CHECKING	6
gemtuzumab ozogamicin Mylotarg	761060 Product 761060/001	For Injection · Intravenous 4.5MG Single-Dose Vial FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
GEPIRONE HYDROCHLORIDE EXXUA	021164 Product 021164/001	TABLET, EXTENDED RELEASE · ORAL EQ 18.2MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	1
GEPIRONE HYDROCHLORIDE EXXUA	021164 Product 021164/002	TABLET, EXTENDED RELEASE · ORAL EQ 36.3MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	1
GEPIRONE HYDROCHLORIDE EXXUA	021164 Product 021164/003	TABLET, EXTENDED RELEASE · ORAL EQ 54.5MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	1
GEPIRONE HYDROCHLORIDE EXXUA	021164 Product 021164/004	TABLET, EXTENDED RELEASE · ORAL EQ 72.6MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	1
GEPOTIDACIN MESYLATE BLUJEPA	218230 Product 218230/001	TABLET · ORAL EQ 750MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	4
GILTERITINIB FUMARATE XOSPATA	211349 Product 211349/001	TABLET · ORAL EQ 40MG BASE FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	8
GIVINOSTAT HYDROCHLORIDE DUVYZAT	217865 Product 217865/001	SUSPENSION · ORAL EQ 8.86MG BASE/ML FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	5
GIVOSIRAN SODIUM GIVLAARI	212194 Product 212194/001	SOLUTION · SUBCUTANEOUS EQ 189MG BASE/ML (EQ 189MG BASE/ML) FDA marketing: Prescription	2034 CANDIDATE FINAL	8
GLASDEGIB MALEATE DAURISMO	210656 Product 210656/001	TABLET · ORAL EQ 25MG BASE FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	5
GLASDEGIB MALEATE DAURISMO	210656 Product 210656/002	TABLET · ORAL EQ 100MG BASE FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	5
GLATIRAMER ACETATE COPAXONE	020622 Product 020622/003	INJECTABLE · SUBCUTANEOUS 40MG/ML FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
GLECAPREVIR; PIBRENTASVIR MAVYRET	209394 Product 209394/001	TABLET · ORAL 100MG;40MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	10
GLECAPREVIR; PIBRENTASVIR MAVYRET	215110 Product 215110/001	PELLETS · ORAL 50MG/PACKET;20MG/PACKET FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	8
GLIPIZIDE GLIPIZIDE	074305 Product 074305/003	TABLET · ORAL 2.5MG FDA marketing: Prescription	Master only	0
glofitamab-gxbm Columvi	761309 Product 761309/001	Injection · Intravenous 2.5MG/2.5ML (1MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 DEEP_REVIEW FINAL_CHECKING	1
glofitamab-gxbm Columvi	761309 Product 761309/002	Injection · Intravenous 10MG/10ML (1MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 DEEP_REVIEW FINAL_CHECKING	1
GLUCAGON BAQSIMI	210134 Product 210134/001	POWDER · NASAL 3MG FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	3
GLUCAGON GVOKE HYPOPEN	212097 Product 212097/003	SOLUTION · SUBCUTANEOUS 0.5MG/0.1ML (0.5MG/0.1ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	2
GLUCAGON GVOKE HYPOPEN	212097 Product 212097/004	SOLUTION · SUBCUTANEOUS 1MG/0.2ML (1MG/0.2ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	2
GLUCAGON GVOKE KIT	212097 Product 212097/005	SOLUTION · SUBCUTANEOUS 1MG/0.2ML (1MG/0.2ML) FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	1
GLUCAGON GVOKE PFS	212097 Product 212097/001	SOLUTION · SUBCUTANEOUS 0.5MG/0.1ML (0.5MG/0.1ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	2
GLUCAGON GVOKE PFS	212097 Product 212097/002	SOLUTION · SUBCUTANEOUS 1MG/0.2ML (1MG/0.2ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	2
GLUCAGON GVOKE VIALDX	212097 Product 212097/006	SOLUTION · INTRAVENOUS 1MG/0.2ML (1MG/0.2ML) FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	0
GLUCAGON HYDROCHLORIDE GLUCAGON	201849 Product 201849/001	POWDER · INTRAMUSCULAR, INTRAVENOUS EQ 1MG BASE/VIAL FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	0
GLUCAGON HYDROCHLORIDE GLUCAGON	201849 Product 201849/002	POWDER · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS EQ 1MG BASE/VIAL FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	0
glucarpidase Voraxaze	125327 Product 125327/001	For Injection · Intravenous 1,000UNITS Single-Dose Vial FDA marketing: Prescription	2024 CANDIDATE FINAL	0
GLYCEROL PHENYLBUTYRATE RAVICTI	203284 Product 203284/001	LIQUID · ORAL 1.1GM/ML FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	14
GLYCOPYRROLATE CUVPOSA	022571 Product 022571/001	SOLUTION · ORAL 1MG/5ML FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
GLYCOPYRROLATE DARTISLA ODT	215019 Product 215019/001	TABLET, ORALLY DISINTEGRATING · ORAL 1.7MG FDA marketing: Discontinued	2023 DISQUALIFIED FINAL	0
GLYCOPYRROLATE DARTISLA ODT	215019 Product 215019/002	TABLET, ORALLY DISINTEGRATING · ORAL 0.85MG FDA marketing: Discontinued	2023 DISQUALIFIED FINAL	0
GLYCOPYRROLATE GLYCOPYRROLATE	214919 Product 214919/001	SOLUTION · INTRAMUSCULAR, INTRAVENOUS 0.6MG/3ML (0.2MG/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
GLYCOPYRROLATE GLYRX-PF	210997 Product 210997/001	SOLUTION · INTRAMUSCULAR, INTRAVENOUS 0.2MG/ML (0.2MG/ML) FDA marketing: Discontinued	2018 DEEP_REVIEW PROVISIONAL	0
GLYCOPYRROLATE GLYRX-PF	210997 Product 210997/002	SOLUTION · INTRAMUSCULAR, INTRAVENOUS 0.4MG/2ML (0.2MG/ML) FDA marketing: Prescription	2018 DEEP_REVIEW PROVISIONAL	0
GLYCOPYRROLATE GLYRX-PF	210997 Product 210997/003	SOLUTION · INTRAMUSCULAR, INTRAVENOUS 1MG/5ML (0.2MG/ML) FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	0
GLYCOPYRROLATE GLYRX-PF	210997 Product 210997/004	SOLUTION · INTRAMUSCULAR, INTRAVENOUS 0.6MG/3ML (0.2MG/ML) FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	0
GLYCOPYRROLATE LONHALA MAGNAIR KIT	208437 Product 208437/001	SOLUTION · INHALATION 25MCG/ML FDA marketing: Discontinued	2023 DISCONTINUED FINAL	9
GLYCOPYRROLATE SEEBRI NEOHALER	207923 Product 207923/001	POWDER · INHALATION 15.6MCG/INH FDA marketing: Discontinued	2020 DISCONTINUED FINAL	2
GLYCOPYRROLATE; INDACATEROL MALEATE UTIBRON NEOHALER	207930 Product 207930/001	POWDER · INHALATION 15.6MCG/INH;27.5MCG/INH FDA marketing: Discontinued	2020 DISCONTINUED FINAL	2
GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE PREVDUO	216903 Product 216903/001	SOLUTION · INTRAVENOUS 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) FDA marketing: Discontinued	2026 DISCONTINUED FINAL	5
GLYCOPYRRONIUM TOSYLATE QBREXZA	210361 Product 210361/001	CLOTH · TOPICAL EQ 2.4% BASE FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	8
golimumab Simponi	125289 Product 125289/001	Injection · Subcutaneous 50MG/0.5ML Autoinjector FDA marketing: Rx	2021 DEEP_REVIEW FINAL	14
golimumab Simponi	125289 Product 125289/002	Injection · Subcutaneous 50MG/0.5ML Pre-Filled Syringe FDA marketing: Rx	2021 DEEP_REVIEW FINAL	14
golimumab Simponi	125289 Product 125289/003	Injection · Subcutaneous 100MG/ML Autoinjector FDA marketing: Rx	2021 DEEP_REVIEW FINAL	14
golimumab Simponi	125289 Product 125289/004	Injection · Subcutaneous 100MG/ML Pre-Filled Syringe FDA marketing: Rx	2021 DEEP_REVIEW FINAL	14
golimumab Simponi Aria	125433 Product 125433/001	Injection · Intravenous 50MG/4ML (12.5MG/ML) Single-Dose Vial FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	12
golimumab-sldi Immgolis	761452 Product 761452/001	Injection · Subcutaneous 50MG/0.5ML (100MG/ML) Pre-Filled Syringe FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	0
golimumab-sldi Immgolis	761452 Product 761452/002	Injection · Subcutaneous 100MG/ML Pre-Filled Syringe FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	0
golimumab-sldi Immgolis Intri	761452 Product 761452/003	Injection · Intravenous 50MG/4ML (12.5MG/ML) Single-Dose Vial FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	0
GOLODIRSEN VYONDYS 53	211970 Product 211970/001	SOLUTION · INTRAVENOUS 100MG/2ML (50MG/ML) FDA marketing: Prescription	2028 CANDIDATE FINAL	1
GRANISETRON SUSTOL	022445 Product 022445/001	INJECTABLE · SUBCUTANEOUS 10MG/0.4ML (10MG/0.4ML) FDA marketing: Discontinued	2019 DEEP_REVIEW FINAL	7
GUAIFENESIN; HYDROCODONE BITARTRATE FLOWTUSS	022424 Product 022424/001	SOLUTION · ORAL 200MG/5ML;2.5MG/5ML FDA marketing: Discontinued	2018 DISCONTINUED FINAL	0
GUAIFENESIN; HYDROCODONE BITARTRATE OBREDON	205474 Product 205474/001	SOLUTION · ORAL 200MG/5ML;2.5MG/5ML FDA marketing: Discontinued	Master only	3
GUAIFENESIN; HYDROCODONE BITARTRATE XTRELUS	208085 Product 208085/001	TABLET · ORAL 400MG;5MG FDA marketing: Discontinued	2018 DEEP_REVIEW PROVISIONAL	0
GUAIFENESIN; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE HYCOFENIX	022279 Product 022279/001	SOLUTION · ORAL 200MG/5ML;2.5MG/5ML;30MG/5ML FDA marketing: Discontinued	2018 DISCONTINUED FINAL	0
guselkumab Tremfya	761061 Product 761061/001	Injection · Subcutaneous 100MG/ML Pre-Filled Syringe FDA marketing: Prescription	2031 CANDIDATE FINAL	0
HALOBETASOL PROPIONATE BRYHALI	209355 Product 209355/001	LOTION · TOPICAL 0.01% FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	6
HALOBETASOL PROPIONATE LEXETTE	210566 Product 210566/001	AEROSOL, FOAM · TOPICAL 0.05% FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	2
HALOBETASOL PROPIONATE ULTRAVATE	208183 Product 208183/001	LOTION · TOPICAL 0.05% FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	1
HALOBETASOL PROPIONATE; TAZAROTENE DUOBRII	209354 Product 209354/001	LOTION · TOPICAL 0.01%;0.045% FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	10
HALOPERIDOL HALOPERIDOL	218210 Product 218210/001	TABLET · ORAL 0.5MG FDA marketing: Prescription	Master only	0
HALOPERIDOL HALOPERIDOL	218210 Product 218210/002	TABLET · ORAL 1MG FDA marketing: Prescription	Master only	0
HALOPERIDOL HALOPERIDOL	218210 Product 218210/003	TABLET · ORAL 2MG FDA marketing: Prescription	Master only	0
HALOPERIDOL HALOPERIDOL	218210 Product 218210/004	TABLET · ORAL 5MG FDA marketing: Prescription	Master only	0
HALOPERIDOL HALOPERIDOL	218210 Product 218210/005	TABLET · ORAL 10MG FDA marketing: Prescription	Master only	0
HALOPERIDOL HALOPERIDOL	218210 Product 218210/006	TABLET · ORAL 20MG FDA marketing: Prescription	Master only	0
HELIUM HELIUM, USP	205819 Product 205819/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
HELIUM HELIUM, USP	205843 Product 205843/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
HELIUM HELIUM, USP	205851 Product 205851/001	GAS · INHALATION N/A FDA marketing: Discontinued	Master only	0
HELIUM HELIUM, USP	205911 Product 205911/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
HELIUM HELIUM, USP	205912 Product 205912/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
HELIUM HELIUM, USP	206026 Product 206026/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
HELIUM HELIUM, USP	206826 Product 206826/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
HELIUM HELIUM, USP	209033 Product 209033/000	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
HELIUM HELIUM, USP	211781 Product 211781/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
HELIUM HELIUM, USP	212539 Product 212539/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
HELIUM HELIUM, USP	213609 Product 213609/000	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
HELIUM HELIUM, USP	213727 Product 213727/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
HELIUM HELIUM, USP	213990 Product 213990/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
HELIUM HELIUM, USP	214937 Product 214937/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
HELIUM HELIUM, USP	216307 Product 216307/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
HEPARIN SODIUM HEPARIN SODIUM	017029 Product 017029/020	INJECTABLE · INJECTION 10,000 UNITS/ML FDA marketing: Prescription	2011 DEEP_REVIEW FINAL	0
HEPARIN SODIUM HEPARIN SODIUM	201370 Product 201370/001	INJECTABLE · INJECTION 1,000 UNITS/ML FDA marketing: Discontinued	DISCONTINUED FINAL	0
HEPARIN SODIUM HEPARIN SODIUM	201370 Product 201370/002	INJECTABLE · INJECTION 5,000 UNITS/ML FDA marketing: Discontinued	DISCONTINUED FINAL	0
HEPARIN SODIUM HEPARIN SODIUM	201370 Product 201370/003	INJECTABLE · INJECTION 10,000 UNITS/ML FDA marketing: Discontinued	DISCONTINUED FINAL	0
HEPARIN SODIUM HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	019953 Product 019953/002	INJECTABLE · INJECTION 200 UNITS/100ML FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%	017029 Product 017029/021	INJECTABLE · INJECTION 40 UNITS/ML FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	017029 Product 017029/022	INJECTABLE · INJECTION 50 UNITS/ML FDA marketing: Prescription	2017 DEEP_REVIEW PROVISIONAL	0
HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	017029 Product 017029/023	INJECTABLE · INJECTION 100 UNITS/ML FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	0
HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	017029 Product 017029/024	INJECTABLE · INJECTION 50 UNITS/ML FDA marketing: Prescription	2017 DEEP_REVIEW PROVISIONAL	0
HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	017029 Product 017029/025	INJECTABLE · INJECTION 100 UNITS/ML FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	0
HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	019953 Product 019953/003	INJECTABLE · INJECTION 5,000 UNITS/100ML FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	019953 Product 019953/004	INJECTABLE · INJECTION 10,000 UNITS/100ML FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
HEPARIN SODIUM HEPARIN SODIUM PRESERVATIVE FREE	017029 Product 017029/019	INJECTABLE · INJECTION 10,000 UNITS/ML FDA marketing: Prescription	1987 EXISTING_GENERIC DISQUALIFIED	0
HEPARIN SODIUM HEPARIN SODIUM PRESERVATIVE FREE	201370 Product 201370/004	INJECTABLE · INJECTION 1,000 UNITS/ML FDA marketing: Prescription	2011 DEEP_REVIEW FINAL	0
HEPARIN SODIUM; TAUROLIDINE DEFENCATH	214520 Product 214520/001	SOLUTION · N/A 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	2
HEPARIN SODIUM; TAUROLIDINE DEFENCATH	214520 Product 214520/002	SOLUTION · N/A 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	2
HEXAMINOLEVULINATE HYDROCHLORIDE CYSVIEW KIT	022555 Product 022555/001	FOR SOLUTION · INTRAVESICAL 100MG/VIAL FDA marketing: Prescription	2010 EXCLUDED FINAL	3
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	220509 Product 220509/001	TABLET · ORAL 1.5MG;5MG FDA marketing: Prescription	Master only	0
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE	218248 Product 218248/001	SOLUTION · ORAL 50MG/5ML FDA marketing: Prescription	Master only	0
HYDROCHLOROTHIAZIDE INZIRQO	219141 Product 219141/001	FOR SUSPENSION · ORAL 10MG/ML FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	1
HYDROCODONE BITARTRATE HYSINGLA ER	206627 Product 206627/001	TABLET, EXTENDED RELEASE · ORAL 20MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	19
HYDROCODONE BITARTRATE HYSINGLA ER	206627 Product 206627/002	TABLET, EXTENDED RELEASE · ORAL 30MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	19
HYDROCODONE BITARTRATE HYSINGLA ER	206627 Product 206627/003	TABLET, EXTENDED RELEASE · ORAL 40MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	19
HYDROCODONE BITARTRATE HYSINGLA ER	206627 Product 206627/004	TABLET, EXTENDED RELEASE · ORAL 60MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	19
HYDROCODONE BITARTRATE HYSINGLA ER	206627 Product 206627/005	TABLET, EXTENDED RELEASE · ORAL 80MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	19
HYDROCODONE BITARTRATE HYSINGLA ER	206627 Product 206627/006	TABLET, EXTENDED RELEASE · ORAL 100MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	19
HYDROCODONE BITARTRATE HYSINGLA ER	206627 Product 206627/007	TABLET, EXTENDED RELEASE · ORAL 120MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	19
HYDROCODONE BITARTRATE VANTRELA ER	207975 Product 207975/001	TABLET, EXTENDED RELEASE · ORAL 15MG FDA marketing: Discontinued	2018 WITHDRAWN FINAL	3
HYDROCODONE BITARTRATE VANTRELA ER	207975 Product 207975/002	TABLET, EXTENDED RELEASE · ORAL 30MG FDA marketing: Withdrawn	2018 WITHDRAWN FINAL	3
HYDROCODONE BITARTRATE VANTRELA ER	207975 Product 207975/003	TABLET, EXTENDED RELEASE · ORAL 45MG FDA marketing: Discontinued	2018 WITHDRAWN FINAL	3
HYDROCODONE BITARTRATE VANTRELA ER	207975 Product 207975/004	TABLET, EXTENDED RELEASE · ORAL 60MG FDA marketing: Withdrawn	2018 WITHDRAWN FINAL	3
HYDROCODONE BITARTRATE VANTRELA ER	207975 Product 207975/005	TABLET, EXTENDED RELEASE · ORAL 90MG FDA marketing: Discontinued	2018 WITHDRAWN FINAL	3
HYDROCODONE BITARTRATE ZOHYDRO ER	202880 Product 202880/001	CAPSULE, EXTENDED RELEASE · ORAL 10MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	16
HYDROCODONE BITARTRATE ZOHYDRO ER	202880 Product 202880/002	CAPSULE, EXTENDED RELEASE · ORAL 15MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	16
HYDROCODONE BITARTRATE ZOHYDRO ER	202880 Product 202880/003	CAPSULE, EXTENDED RELEASE · ORAL 20MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	16
HYDROCODONE BITARTRATE ZOHYDRO ER	202880 Product 202880/004	CAPSULE, EXTENDED RELEASE · ORAL 30MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	16
HYDROCODONE BITARTRATE ZOHYDRO ER	202880 Product 202880/005	CAPSULE, EXTENDED RELEASE · ORAL 40MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	16
HYDROCODONE BITARTRATE ZOHYDRO ER	202880 Product 202880/006	CAPSULE, EXTENDED RELEASE · ORAL 50MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	16
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE REZIRA	022442 Product 022442/001	SOLUTION · ORAL 5MG/5ML;60MG/5ML FDA marketing: Discontinued	2023 WITHDRAWN FINAL	0
HYDROCORTISONE ALKINDI SPRINKLE	213876 Product 213876/001	GRANULE · ORAL 0.5MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL_CHECKING	3
HYDROCORTISONE ALKINDI SPRINKLE	213876 Product 213876/002	GRANULE · ORAL 1MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL_CHECKING	3
HYDROCORTISONE ALKINDI SPRINKLE	213876 Product 213876/003	GRANULE · ORAL 2MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL_CHECKING	3
HYDROCORTISONE ALKINDI SPRINKLE	213876 Product 213876/004	GRANULE · ORAL 5MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL_CHECKING	3
HYDROCORTISONE KHINDIVI	218980 Product 218980/001	SOLUTION · ORAL 1MG/ML FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	2
HYDROGEN PEROXIDE ESKATA	209305 Product 209305/001	SOLUTION · TOPICAL 40% FDA marketing: Discontinued	2019 DISCONTINUED FINAL	5
HYDROMORPHONE HYDROCHLORIDE DILAUDID	019034 Product 019034/006	INJECTABLE · INJECTION 0.2MG/ML FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	2
HYDROMORPHONE HYDROCHLORIDE DILAUDID	019034 Product 019034/007	INJECTABLE · INJECTION 0.5MG/0.5ML FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	2
HYDROMORPHONE HYDROCHLORIDE EXALGO	021217 Product 021217/001	TABLET, EXTENDED RELEASE · ORAL 8MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	2
HYDROMORPHONE HYDROCHLORIDE EXALGO	021217 Product 021217/002	TABLET, EXTENDED RELEASE · ORAL 12MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	2
HYDROMORPHONE HYDROCHLORIDE EXALGO	021217 Product 021217/003	TABLET, EXTENDED RELEASE · ORAL 16MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	2
HYDROMORPHONE HYDROCHLORIDE EXALGO	021217 Product 021217/004	TABLET, EXTENDED RELEASE · ORAL 32MG FDA marketing: Discontinued	2020 WITHDRAWN FINAL	2
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE	200403 Product 200403/001	INJECTABLE · INJECTION 1MG/ML FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE	200403 Product 200403/002	INJECTABLE · INJECTION 2MG/ML FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE	200403 Product 200403/003	INJECTABLE · INJECTION 4MG/ML FDA marketing: Prescription	2011 DEEP_REVIEW FINAL	0
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE	200403 Product 200403/004	INJECTABLE · INJECTION 0.5MG/0.5ML FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE	200403 Product 200403/005	INJECTABLE · INJECTION 0.25MG/0.5ML FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE	217812 Product 217812/001	SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 40MG/20ML (2MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	1
HYDROXOCOBALAMIN CYANOKIT	022041 Product 022041/001	INJECTABLE · INJECTION 5GM/VIAL (5GM/KIT) FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	1
HYDROXYCHLOROQUINE SULFATE SOVUNA	214581 Product 214581/001	TABLET · ORAL 200MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
HYDROXYCHLOROQUINE SULFATE SOVUNA	214581 Product 214581/002	TABLET · ORAL 300MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
HYDROXYUREA SIKLOS	208843 Product 208843/001	TABLET · ORAL 100MG FDA marketing: Prescription	2024 DEEP_REVIEW PROVISIONAL	0
HYDROXYUREA SIKLOS	208843 Product 208843/002	TABLET · ORAL 1GM FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	0
HYDROXYUREA XROMI	216593 Product 216593/001	SOLUTION · ORAL 100MG/ML FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	1
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE	219561 Product 219561/001	SYRUP · ORAL 10MG/5ML FDA marketing: Prescription	Master only	0
ibalizumab-uiyk Trogarzo	761065 Product 761065/001	Injection · Intravenous 200MG/1.33ML (150MG/ML) Single-Dose Vial FDA marketing: Prescription	2030 CANDIDATE FINAL	0
IBERDOMIDE HYDROCHLORIDE ZENBEXUS	221075 Product 221075/001	CAPSULE · ORAL EQ 0.75MG BASE FDA marketing: Prescription	2039 CANDIDATE FINAL	7
IBERDOMIDE HYDROCHLORIDE ZENBEXUS	221075 Product 221075/002	CAPSULE · ORAL EQ 1MG BASE FDA marketing: Prescription	2039 CANDIDATE FINAL	7
IBREXAFUNGERP CITRATE BREXAFEMME	214900 Product 214900/001	TABLET · ORAL EQ 150MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	5
IBRUTINIB IMBRUVICA	205552 Product 205552/001	CAPSULE · ORAL 140MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	34
IBRUTINIB IMBRUVICA	205552 Product 205552/002	CAPSULE · ORAL 70MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	33
IBRUTINIB IMBRUVICA	210563 Product 210563/001	TABLET · ORAL 140MG FDA marketing: RX	2028 DEEP_REVIEW FINAL	35
IBRUTINIB IMBRUVICA	210563 Product 210563/002	TABLET · ORAL 280MG FDA marketing: RX	2028 DEEP_REVIEW FINAL	34
IBRUTINIB IMBRUVICA	210563 Product 210563/003	TABLET · ORAL 420MG FDA marketing: RX	2028 DEEP_REVIEW FINAL	34
IBRUTINIB IMBRUVICA	210563 Product 210563/004	TABLET · ORAL 560MG FDA marketing: DISCONTINUED	2023 DISCONTINUED FINAL	35
IBRUTINIB IMBRUVICA	217003 Product 217003/001	SUSPENSION · ORAL 70MG/ML FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	31
IBRUTINIB IMBRUVICA	217003 Product 217003/005	TABLET · ORAL 230MG FDA marketing: Prescription	Master only	0
IBUPROFEN CALDOLOR	022348 Product 022348/003	SOLUTION · INTRAVENOUS 800MG/200ML (4MG/ML) FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	6
IBUPROFEN MOTRIN IB	020516 Product 020516/002	SUSPENSION · ORAL 200MG/10ML FDA marketing: Over-the-counter	2026 EXCLUDED FINAL	0
IBUPROFEN SODIUM ADVIL	201803 Product 201803/001	TABLET · ORAL EQ 200MG BASE FDA marketing: Over-the-counter	2012 EXCLUDED FINAL	0
IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE ADVIL CONGESTION RELIEF	022565 Product 022565/001	TABLET · ORAL 200MG;10MG FDA marketing: Over-the-counter	2010 EXCLUDED FINAL	0
ICATIBANT ACETATE FIRAZYR	022150 Product 022150/001	INJECTABLE · SUBCUTANEOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	0
ICOSAPENT ETHYL VASCEPA	202057 Product 202057/001	CAPSULE · ORAL 1GM FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	60
ICOSAPENT ETHYL VASCEPA	202057 Product 202057/002	CAPSULE · ORAL 500MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	59
ICOTROKINRA HYDROCHLORIDE ICOTYDE	220149 Product 220149/001	TABLET · ORAL EQ 200MG BASE FDA marketing: Prescription	2041 DEEP_REVIEW FINAL	3
idarucizumab Praxbind	761025 Product 761025/001	Injection · Intravenous 2.5G/50ML Single-Dose Vial FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	0
IDELALISIB ZYDELIG	205858 Product 205858/001	TABLET · ORAL 100MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	4
IDELALISIB ZYDELIG	205858 Product 205858/002	TABLET · ORAL 150MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	4
ILOPROST AURLUMYN	217933 Product 217933/001	SOLUTION · INTRAVENOUS 100MCG/ML (100MCG/ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL_CHECKING	2
IMATINIB MESYLATE IMKELDI	219097 Product 219097/001	SOLUTION · ORAL EQ 80MG BASE/ML FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	1
IMETELSTAT SODIUM RYTELO	217779 Product 217779/001	POWDER · INTRAVENOUS EQ 47MG BASE/VIAL FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	6
IMETELSTAT SODIUM RYTELO	217779 Product 217779/002	POWDER · INTRAVENOUS EQ 188MG BASE/VIAL FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	6
IMIQUIMOD ZYCLARA	022483 Product 022483/001	CREAM · TOPICAL 3.75% FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	8
IMIQUIMOD ZYCLARA	022483 Product 022483/002	CREAM · TOPICAL 2.5% FDA marketing: Prescription	2029 CANDIDATE FINAL	2
IMLUNESTRANT TOSYLATE INLURIYO	218881 Product 218881/001	TABLET · ORAL EQ 200MG BASE FDA marketing: Prescription	2039 CANDIDATE FINAL	2
INAVOLISIB ITOVEBI	219249 Product 219249/001	TABLET · ORAL 3MG FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	7
INAVOLISIB ITOVEBI	219249 Product 219249/002	TABLET · ORAL 9MG FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	7
INCLISIRAN SODIUM LEQVIO	214012 Product 214012/001	SOLUTION · SUBCUTANEOUS EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) FDA marketing: Prescription	2036 CANDIDATE FINAL	10
incobotulinumtoxinA Xeomin	125360 Product 125360/001	For Injection · Intramuscular, Intraglandular 50UNITS Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
incobotulinumtoxinA Xeomin	125360 Product 125360/002	For Injection · Intramuscular, Intraglandular 100UNITS Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
incobotulinumtoxinA Xeomin	125360 Product 125360/003	For Injection · Intramuscular, Intraglandular 200UNITS Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
INDACATEROL MALEATE ARCAPTA NEOHALER	022383 Product 022383/001	POWDER · INHALATION EQ 75MCG BASE FDA marketing: Discontinued	2025 DEEP_REVIEW FINAL_CHECKING	1
INDIGOTINDISULFONATE SODIUM BLUDIGO	216264 Product 216264/001	SOLUTION · INTRAVENOUS 40MG/5ML (8MG/ML) FDA marketing: Prescription	2022 EXCLUDED FINAL	3
INDOCYANINE GREEN SPY AGENT GREEN KIT	211580 Product 211580/001	POWDER · INTRAVENOUS, INTERSTITIAL 25MG/VIAL FDA marketing: Prescription	2018 EXCLUDED FINAL	5
INDOCYANINE GREEN ZYOGREEN	218579 Product 218579/001	SOLUTION · INTRAVENOUS, INTERSTITIAL 25MG/10ML (2.5MG/ML) FDA marketing: Prescription	2026 EXCLUDED FINAL	0
INDOMETHACIN INDOMETHACIN	022536 Product 022536/001	INJECTABLE · INJECTION EQ 1MG BASE/VIAL FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
INDOMETHACIN TIVORBEX	204768 Product 204768/001	CAPSULE · ORAL 20MG FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	3
INDOMETHACIN TIVORBEX	204768 Product 204768/002	CAPSULE · ORAL 40MG FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	3
inebilizumab-cdon Uplizna	761142 Product 761142/001	Injection · Intravenous 100MG/10ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	0
INFIGRATINIB PHOSPHATE TRUSELTIQ	214622 Product 214622/001	CAPSULE · ORAL 25MG FDA marketing: DISCONTINUED	2023 DISQUALIFIED FINAL	4
INFIGRATINIB PHOSPHATE TRUSELTIQ	214622 Product 214622/002	CAPSULE · ORAL 100MG FDA marketing: DISCONTINUED	2023 DISQUALIFIED FINAL	4
infliximab-abda Renflexis	761054 Product 761054/001	For Injection · Intravenous 100MG Single-Dose Vial FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
infliximab-axxq Avsola	761086 Product 761086/001	For Injection · Intravenous 100MG Single-Dose Vial FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
infliximab-dyyb Inflectra	125544 Product 125544/001	For Injection · Intravenous 100MG Single-Dose Vial FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
infliximab-dyyb Zymfentra	761358 Product 761358/001	Injection · Subcutaneous 120MG/ML Pre-Filled Syringe FDA marketing: Prescription	2035 DEEP_REVIEW FINAL_CHECKING	1
infliximab-qbtx Ixifi	761072 Product 761072/001	For Injection · Intravenous 100MG Single-Dose Vial FDA marketing: Prescription	2019 DISCONTINUED FINAL	0
INGENOL MEBUTATE PICATO	202833 Product 202833/001	GEL · TOPICAL 0.015% FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	12
INGENOL MEBUTATE PICATO	202833 Product 202833/002	GEL · TOPICAL 0.05% FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	11
INOTERSEN SODIUM TEGSEDI	211172 Product 211172/001	SOLUTION · SUBCUTANEOUS EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) FDA marketing: Discontinued	Master only	3
inotuzumab ozogamicin Besponsa	761040 Product 761040/001	For Injection · Intravenous 0.9MG Single-Dose Vial FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	0
insulin aspart Fiasp	208751 Product 208751/001	Injection · Intravenous, Subcutaneous 1000UNITS/10ML (100UNITS/ML) Multi-Dose Vial FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	0
insulin aspart Fiasp	208751 Product 208751/002	Injection · Subcutaneous 300UNITS/3ML (100UNITS/ML) Autoinjector FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	0
insulin aspart Fiasp	208751 Product 208751/003	Injection · Subcutaneous 300UNITS/3ML (100UNITS/ML) Multi-Dose Cartridge FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	0
insulin aspart-fsan Garzulys	761497 Product 761497/001	Injection · Intravenous, Subcutaneous 1,000UNITS/10ML (100UNITS/ML) Multi-Dose Vial FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	0
insulin aspart-fsan Garzulys	761497 Product 761497/002	Injection · Subcutaneous 300UNITS/3ML (100UNITS/ML) Autoinjector FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	0
insulin aspart-szjj Merilog	761325 Product 761325/001	Injection · Subcutaneous 1,000UNITS/10ML (100UNITS/ML) Multi-Dose Vial FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	0
insulin aspart-szjj Merilog	761325 Product 761325/002	Injection · Subcutaneous 300UNITS/3ML (100UNITS/ML) Autoinjector FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	0
insulin aspart-xjhz Kirsty	761188 Product 761188/001	Injection · Subcutaneous 300UNITS/3ML (100UNITS/ML) Autoinjector FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	0
insulin degludec Tresiba	203314 Product 203314/001	Injection · Subcutaneous 300UNITS/3ML (100UNITS/ML) Autoinjector FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	0
insulin degludec Tresiba	203314 Product 203314/002	Injection · Subcutaneous 600UNITS/3ML (200UNITS/ML) Autoinjector FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	0
insulin degludec Tresiba	203314 Product 203314/003	Injection · Subcutaneous 1,000UNITS/10ML (100UNITS/ML) Multi-Dose Vial FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	0
insulin degludec and insulin aspart Ryzodeg 70/30	203313 Product 203313/001	Injection · Subcutaneous 210UNITS/3ML (70UNITS/ML); 90UNIT/3ML (30UNITS/ML) Autoinjector FDA marketing: Discontinued	DISCONTINUED FINAL	0
insulin degludec and liraglutide Xultophy 100/3.6	208583 Product 208583/001	Injection · Subcutaneous 300UNITS/3ML (100UNITS/ML); 10.8MG/3ML (3.6MG/ML) Autoinjector FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	0
insulin efsitora alfa-gobe Onswik	761408 Product 761408/001	Injection · Subcutaneous 1,500UNITS/3ML (500UNITS/ML) Autoinjector FDA marketing: Prescription	2038 CANDIDATE FINAL_CHECKING	1
insulin efsitora alfa-gobe Onswik	761408 Product 761408/002	Injection · Subcutaneous 3,000UNITS/3ML (1,000UNITS/ML) Autoinjector FDA marketing: Prescription	2038 CANDIDATE FINAL_CHECKING	1
insulin glargine Basaglar	205692 Product 205692/001	Injection · Subcutaneous 300UNITS/3ML (100UNITS/ML) Autoinjector FDA marketing: Prescription	2017 DISCONTINUED FINAL	0
insulin glargine Semglee	210605 Product 210605/001	Injection · Subcutaneous 1,000UNITS/10ML (100 UNITS/ML) Multi-Dose Vial FDA marketing: Prescription	WITHDRAWN FINAL	0
insulin glargine Toujeo	206538 Product 206538/001	Injection · Subcutaneous 450UNITS/1.5ML (300UNITS/ML) Autoinjector FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	0
insulin glargine Toujeo	206538 Product 206538/002	Injection · Subcutaneous 900UNITS/3ML (300UNITS/ML) Autoinjector FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	0
insulin glargine and lixisenatide Soliqua 100/33	208673 Product 208673/001	Injection · Subcutaneous 300UNITS/3ML (100UNITS/ML); 99MCG/3ML (33MCG/ML) Autoinjector FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	0
insulin glargine-aglr Rezvoglar	761215 Product 761215/001	Injection · Subcutaneous 300UNITS/3ML (100UNITS/ML) Autoinjector FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	0
insulin glargine-aldy Langlara	761412 Product 761412/001	Injection · Subcutaneous 300UNITS/3ML (100UNITS/ML) Autoinjector FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	0
insulin glargine-yfgn Semglee	761201 Product 761201/001	Injection · Subcutaneous 1,000UNITS/10ML (100UNITS/ML) Multi-Dose Vial FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	0
insulin glargine-yfgn Semglee	761201 Product 761201/002	Injection · Subcutaneous 300UNITS/3ML (100UNITS/ML) Autoinjector FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	0
insulin human Afrezza	022472 Product 022472/001	Powder · Inhalation 4UNITS/INH Single-Dose Cartridge FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	0
insulin human Afrezza	022472 Product 022472/002	Powder · Inhalation 8UNITS/INH Single-Dose Cartridge FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	0
insulin human Afrezza	022472 Product 022472/003	Powder · Inhalation 12UNITS/INH Single-Dose Cartridge FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	0
insulin human Myxredlin	208157 Product 208157/001	Injection · Intravenous 100UNITS/100ML (1UNIT/ML) Single-Dose Container FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	0
insulin icodec-abae Awiqli	761326 Product 761326/001	Injection · Subcutaneous 2,100UNITS/3ML (700UNITS/ML) Autoinjector FDA marketing: Prescription	2038 CANDIDATE FINAL_CHECKING	2
insulin lispro Admelog	209196 Product 209196/001	Injection · Intravenous, Subcutaneous 1,000UNITS/10ML (100UNITS/ML) Multi-Dose Vial FDA marketing: Prescription	2013 CANDIDATE FINAL	0
insulin lispro Admelog	209196 Product 209196/002	Injection · Subcutaneous 300UNITS/3ML (100UNITS/ML) Autoinjector FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
insulin lispro Admelog	209196 Product 209196/003	Injection · Intravenous, Subcutaneous 300UNITS/3ML (100UNITS/ML) Multi-Dose Vial FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	0
insulin lispro Humalog	205747 Product 205747/001	Injection · Subcutaneous 600UNITS/3ML (200UNITS/ML) Autoinjector FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	0
insulin lispro-aabc Lyumjev	761109 Product 761109/001	Injection · Intravenous, Subcutaneous 1,000UNITS/10ML (100UNITS/ML) Multi-Dose Vial FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	0
insulin lispro-aabc Lyumjev	761109 Product 761109/006	Injection · Intravenous, Subcutaneous 600UNITS/3ML (200UNITS/ML) Autoinjector FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	0
IOBENGUANE I-131 AZEDRA	209607 Product 209607/001	SOLUTION · INTRAVENOUS 15mCi/ML FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	0
IOFLUPANE I-123 DATSCAN	022454 Product 022454/001	SOLUTION · INTRAVENOUS 5mCi/2.5ML (2mCi/ML) FDA marketing: Prescription	2011 EXCLUDED FINAL	0
IOHEXOL OMNIPAQUE 12	018956 Product 018956/009	SOLUTION · ORAL 2.6% FDA marketing: Prescription	2018 EXCLUDED PROVISIONAL	0
IOHEXOL OMNIPAQUE 9	018956 Product 018956/008	SOLUTION · ORAL 1.9% FDA marketing: Prescription	2018 EXCLUDED PROVISIONAL	0
IOHEXOL ORALTAG	205383 Product 205383/001	FOR SOLUTION · ORAL 9.7GM/BOT FDA marketing: Discontinued	2015 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216016 Product 216016/001	SOLUTION · INTRA-ARTERIAL 25GM IODINE/100ML (250MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216016 Product 216016/002	SOLUTION · INTRA-ARTERIAL 15GM IODINE/50ML (300MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216016 Product 216016/003	SOLUTION · INTRA-ARTERIAL 30GM IODINE/100ML (300MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216016 Product 216016/004	SOLUTION · INTRA-ARTERIAL 45GM IODINE/150ML (300MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216016 Product 216016/005	SOLUTION · INTRA-ARTERIAL 60GM IODINE/200ML (300MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216016 Product 216016/006	SOLUTION · INTRA-ARTERIAL 17.5GM IODINE/50ML (350MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216016 Product 216016/007	SOLUTION · INTRA-ARTERIAL 35GM IODINE/100ML (350MG IODINE/ML) FDA marketing: Prescription	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216016 Product 216016/008	SOLUTION · INTRA-ARTERIAL 52.5GM IODINE/150ML (350MG IODINE/ML FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216016 Product 216016/009	SOLUTION · INTRA-ARTERIAL 70GM IODINE/200ML (350MG IODINE/ML) FDA marketing: Prescription	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216016 Product 216016/010	SOLUTION · INTRA-ARTERIAL 20GM IODINE/50ML (400MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216016 Product 216016/011	SOLUTION · INTRA-ARTERIAL 40GM IODINE/100ML (400MG IODINE/ML) FDA marketing: Prescription	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216016 Product 216016/012	SOLUTION · INTRA-ARTERIAL 60GM IODINE/150ML (400MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216016 Product 216016/013	SOLUTION · INTRA-ARTERIAL 80GM IODINE/200ML (400MG IODINE/ML) FDA marketing: Prescription	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216017 Product 216017/001	SOLUTION · INTRAVENOUS 25GM IODINE/100ML (250MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216017 Product 216017/002	SOLUTION · INTRAVENOUS 15GM IODINE/50ML (300MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216017 Product 216017/003	SOLUTION · INTRAVENOUS 30GM IODINE/100ML (300MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216017 Product 216017/004	SOLUTION · INTRAVENOUS 45GM IODINE/150ML (300MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216017 Product 216017/005	SOLUTION · INTRAVENOUS 60GM IODINE/200ML (300MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216017 Product 216017/006	SOLUTION · INTRAVENOUS 17.5GM IODINE/50ML (350MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216017 Product 216017/007	SOLUTION · INTRAVENOUS 35GM IODINE/100ML (350MG IODINE/ML) FDA marketing: Prescription	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216017 Product 216017/008	SOLUTION · INTRAVENOUS 52.5GM IODINE/150ML (350MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216017 Product 216017/009	SOLUTION · INTRAVENOUS 70GM IODINE/200ML (350MG IODINE/ML) FDA marketing: Prescription	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216017 Product 216017/010	SOLUTION · INTRAVENOUS 20GM IODINE/50ML (400MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216017 Product 216017/011	SOLUTION · INTRAVENOUS 40GM IODINE/100ML (400MG IODINE/ML) FDA marketing: Prescription	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216017 Product 216017/012	SOLUTION · INTRAVENOUS 60GM IODINE/150ML (400MG IODINE/ML) FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
IOMEPROL IOMERVU	216017 Product 216017/013	SOLUTION · INTRAVENOUS 80GM IODINE/200ML (400MG IODINE/ML) FDA marketing: Prescription	2024 EXCLUDED FINAL	0
IOPAMIDOL ISOVUE READI	220583 Product 220583/001	SOLUTION · ORAL 200MG FDA marketing: Prescription	Master only	0
IOPAMIDOL ISOVUE READI	220583 Product 220583/002	SOLUTION · ORAL 250MG FDA marketing: Prescription	Master only	0
IOPAMIDOL ISOVUE READI	220583 Product 220583/003	SOLUTION · ORAL 300MG FDA marketing: Prescription	Master only	0
IOPAMIDOL ISOVUE READI	220583 Product 220583/004	SOLUTION · ORAL 370MG FDA marketing: Prescription	Master only	0
IPILIMUMAB YERVOY	125377 Product 125377/001	INJECTABLE · INJECTION 3MG FDA marketing: Prescription	Master only	0
IPTACOPAN HYDROCHLORIDE FABHALTA	218276 Product 218276/001	CAPSULE · ORAL EQ 200MG BASE FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	8
IRINOTECAN HYDROCHLORIDE CAMPTOSAR	020571 Product 020571/003	INJECTABLE · INJECTION 300MG/15ML (20MG/ML) FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
IRINOTECAN HYDROCHLORIDE ONIVYDE	207793 Product 207793/001	INJECTABLE, LIPOSOMAL · INTRAVENOUS EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	14
IRON SUCROSE VENOFER	021135 Product 021135/005	INJECTABLE · INTRAVENOUS EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML) FDA marketing: Discontinued	2013 DISCONTINUED FINAL	0
isatuximab-irfc Sarclisa	761113 Product 761113/001	Injection · Intravenous 100MG/5ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	0
isatuximab-irfc Sarclisa	761113 Product 761113/002	Injection · Intravenous 500MG/25ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	0
isatuximab-irfc Sarclisa Escena	761445 Product 761445/001	Injection · Subcutaneous 1,400MG/10ML (140MG/ML) Single-Dose Vial FDA marketing: Prescription	2032 CANDIDATE FINAL_CHECKING	1
ISAVUCONAZONIUM SULFATE CRESEMBA	207500 Product 207500/001	CAPSULE · ORAL 186MG FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	3
ISAVUCONAZONIUM SULFATE CRESEMBA	207500 Product 207500/002	CAPSULE · ORAL 74.5MG FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	3
ISAVUCONAZONIUM SULFATE CRESEMBA	207501 Product 207501/001	POWDER · INTRAVENOUS 372MG FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	1
ISOPROPYL ALCOHOL ZURAGARD	210872 Product 210872/001	SOLUTION · TOPICAL 70% FDA marketing: Over-the-counter	2019 EXCLUDED FINAL	5
ISOTRETINOIN ABSORICA	021951 Product 021951/001	CAPSULE · ORAL 10MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
ISOTRETINOIN ABSORICA	021951 Product 021951/002	CAPSULE · ORAL 20MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
ISOTRETINOIN ABSORICA	021951 Product 021951/003	CAPSULE · ORAL 30MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
ISOTRETINOIN ABSORICA	021951 Product 021951/004	CAPSULE · ORAL 40MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
ISOTRETINOIN ABSORICA	021951 Product 021951/005	CAPSULE · ORAL 25MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
ISOTRETINOIN ABSORICA	021951 Product 021951/006	CAPSULE · ORAL 35MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
ISOTRETINOIN ABSORICA LD	211913 Product 211913/001	CAPSULE · ORAL 8MG FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	2
ISOTRETINOIN ABSORICA LD	211913 Product 211913/002	CAPSULE · ORAL 16MG FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	2
ISOTRETINOIN ABSORICA LD	211913 Product 211913/003	CAPSULE · ORAL 20MG FDA marketing: Discontinued	DISCONTINUED FINAL	2
ISOTRETINOIN ABSORICA LD	211913 Product 211913/004	CAPSULE · ORAL 24MG FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	2
ISOTRETINOIN ABSORICA LD	211913 Product 211913/005	CAPSULE · ORAL 28MG FDA marketing: Discontinued	2020 DISCONTINUED FINAL	2
ISOTRETINOIN ABSORICA LD	211913 Product 211913/006	CAPSULE · ORAL 32MG FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	2
ISTRADEFYLLINE NOURIANZ	022075 Product 022075/001	TABLET · ORAL 20MG FDA marketing: Prescription	2028 CANDIDATE FINAL_CHECKING	2
ISTRADEFYLLINE NOURIANZ	022075 Product 022075/002	TABLET · ORAL 40MG FDA marketing: Prescription	2028 CANDIDATE FINAL_CHECKING	2
ITRACONAZOLE ONMEL	022484 Product 022484/001	TABLET · ORAL 200MG FDA marketing: Discontinued	2021 DISCONTINUED FINAL	1
ITRACONAZOLE TOLSURA	208901 Product 208901/001	CAPSULE · ORAL 65MG FDA marketing: Prescription	2033 CANDIDATE FINAL_CHECKING	5
IVABRADINE CORLANOR	209964 Product 209964/001	SOLUTION · ORAL 5MG/5ML (1MG/ML) FDA marketing: DISCONTINUED	2026 DISQUALIFIED FINAL	4
IVABRADINE HYDROCHLORIDE CORLANOR	206143 Product 206143/001	TABLET · ORAL EQ 5MG BASE FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	4
IVABRADINE HYDROCHLORIDE CORLANOR	206143 Product 206143/002	TABLET · ORAL EQ 7.5MG BASE FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	4
IVACAFTOR KALYDECO	203188 Product 203188/001	TABLET · ORAL 150MG FDA marketing: RX	2028 DEEP_REVIEW FINAL	9
IVACAFTOR KALYDECO	207925 Product 207925/001	GRANULE · ORAL 50MG/PACKET FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	14
IVACAFTOR KALYDECO	207925 Product 207925/002	GRANULE · ORAL 75MG/PACKET FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	14
IVACAFTOR KALYDECO	207925 Product 207925/003	GRANULE · ORAL 25MG/PACKET FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	14
IVACAFTOR KALYDECO	207925 Product 207925/004	GRANULE · ORAL 5.8MG/PACKET FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	14
IVACAFTOR KALYDECO	207925 Product 207925/005	GRANULE · ORAL 13.4MG/PACKET FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	14
IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED)	210491 Product 210491/001	TABLET · ORAL 150MG;150MG, 100MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	26
IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED)	210491 Product 210491/002	TABLET · ORAL 75MG;75MG, 50MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	25
IVACAFTOR; LUMACAFTOR ORKAMBI	206038 Product 206038/001	TABLET · ORAL 125MG;200MG FDA marketing: Prescription	2031 CANDIDATE FINAL	23
IVACAFTOR; LUMACAFTOR ORKAMBI	206038 Product 206038/002	TABLET · ORAL 125MG;100MG FDA marketing: Prescription	2031 CANDIDATE FINAL	22
IVACAFTOR; LUMACAFTOR ORKAMBI	211358 Product 211358/001	GRANULE · ORAL 125MG/PACKET;100MG/PACKET FDA marketing: Prescription	2031 CANDIDATE FINAL	21
IVACAFTOR; LUMACAFTOR ORKAMBI	211358 Product 211358/002	GRANULE · ORAL 188MG/PACKET;150MG/PACKET FDA marketing: Prescription	2031 CANDIDATE FINAL	21
IVACAFTOR; LUMACAFTOR ORKAMBI	211358 Product 211358/003	GRANULE · ORAL 94MG/PACKET;75MG/PACKET FDA marketing: Prescription	2031 CANDIDATE FINAL	21
IVERMECTIN SKLICE	202736 Product 202736/001	LOTION · TOPICAL 0.5% FDA marketing: Over-the-counter	2012 EXCLUDED FINAL	0
IVERMECTIN SOOLANTRA	206255 Product 206255/001	CREAM · TOPICAL 1% FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	5
IVOSIDENIB TIBSOVO	211192 Product 211192/001	TABLET · ORAL 250MG FDA marketing: Prescription	2039 CANDIDATE FINAL	10
IXAZOMIB CITRATE NINLARO	208462 Product 208462/001	CAPSULE · ORAL EQ 2.3MG BASE FDA marketing: Prescription	2029 CANDIDATE FINAL	7
IXAZOMIB CITRATE NINLARO	208462 Product 208462/002	CAPSULE · ORAL EQ 3MG BASE FDA marketing: Prescription	2029 CANDIDATE FINAL	7
IXAZOMIB CITRATE NINLARO	208462 Product 208462/003	CAPSULE · ORAL EQ 4MG BASE FDA marketing: Prescription	2029 CANDIDATE FINAL	7
ixekizumab Taltz	125521 Product 125521/001	Injection · Subcutaneous 80MG/ML Autoinjector FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	0
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE	218355 Product 218355/001	INJECTABLE · INJECTION 30MG/ML FDA marketing: Prescription	Master only	0
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE	221041 Product 221041/001	INJECTABLE · INJECTION 15MG/ML FDA marketing: Prescription	Master only	0
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE	221041 Product 221041/002	INJECTABLE · INJECTION 30MG/ML FDA marketing: Prescription	Master only	0
KETOROLAC TROMETHAMINE SPRIX	022382 Product 022382/001	SPRAY, METERED · NASAL 15.75MG/SPRAY FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	2
KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE OMIDRIA	205388 Product 205388/001	SOLUTION · IRRIGATION EQ 0.3% BASE;EQ 1% BASE FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	3
KETOTIFEN FUMARATE ACUVUE THERAVISION WITH KETOTIFEN	022388 Product 022388/001	DRUG-ELUTING CONTACT LENS · OPHTHALMIC EQ 19MCG BASE FDA marketing: Discontinued	2023 DISCONTINUED FINAL	2
KETOTIFEN FUMARATE CHILDREN'S ALAWAY	021996 Product 021996/002	SOLUTION/DROPS · OPHTHALMIC EQ 0.025% BASE FDA marketing: Over-the-counter	2015 EXCLUDED FINAL	0
kit for the preparation of technetium Tc-99m albumin aggregated Pulmotech MAA	210089 Product 210089/001	For Injectable Suspension · Intravenous, Intraperitoneal 2MG Multi-Dose Vial FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	0
L-GLUTAMINE ENDARI	208587 Product 208587/001	FOR SOLUTION · ORAL 5GM/PACKET FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE	213330 Product 213330/005	SOLUTION · INTRAVENOUS 10MG/2ML (5MG/ML) FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	1
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE	213330 Product 213330/006	SOLUTION · INTRAVENOUS 20MG/4ML (5MG/ML) FDA marketing: Prescription	1998 CANDIDATE FINAL	1
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE IN DEXTROSE	213330 Product 213330/001	SOLUTION · INTRAVENOUS 200MG/200ML (1MG/ML) FDA marketing: Prescription	1998 CANDIDATE FINAL	1
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	213330 Product 213330/002	SOLUTION · INTRAVENOUS 100MG/100ML (1MG/ML) FDA marketing: Prescription	1998 CANDIDATE FINAL	1
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	213330 Product 213330/003	SOLUTION · INTRAVENOUS 200MG/200ML (1MG/ML) FDA marketing: Prescription	1998 CANDIDATE FINAL	1
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	213330 Product 213330/004	SOLUTION · INTRAVENOUS 300MG/300ML (1MG/ML) FDA marketing: Prescription	1998 CANDIDATE FINAL	1
LACOSAMIDE MOTPOLY XR	216185 Product 216185/001	CAPSULE, EXTENDED RELEASE · ORAL 100MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	3
LACOSAMIDE MOTPOLY XR	216185 Product 216185/002	CAPSULE, EXTENDED RELEASE · ORAL 150MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	3
LACOSAMIDE MOTPOLY XR	216185 Product 216185/003	CAPSULE, EXTENDED RELEASE · ORAL 200MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	3
LACOSAMIDE VIMPAT	022255 Product 022255/001	SOLUTION · ORAL 10MG/ML FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
LACTITOL PIZENSY	211281 Product 211281/001	FOR SOLUTION · ORAL 10GM FDA marketing: Discontinued	2020 DISCONTINUED FINAL	1
LACTITOL PIZENSY	211281 Product 211281/002	SOLUTION · ORAL 20G FDA marketing: Prescription	Master only	0
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE	205626 Product 205626/001	TABLET · ORAL 150MG;200MG;300MG FDA marketing: Discontinued	2018 DISQUALIFIED FINAL	0
LAMIVUDINE; RALTEGRAVIR POTASSIUM DUTREBIS	206510 Product 206510/001	TABLET · ORAL 150MG;EQ 300MG BASE FDA marketing: DISCONTINUED	2015 DISQUALIFIED FINAL	1
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE CIMDUO	022141 Product 022141/001	TABLET · ORAL 300MG;300MG FDA marketing: Prescription	2018 DEEP_REVIEW PROVISIONAL	0
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	022344 Product 022344/001	TABLET · ORAL 300MG;300MG FDA marketing: Discontinued	2018 DEEP_REVIEW PROVISIONAL	0
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE TEMIXYS	211284 Product 211284/001	TABLET · ORAL 300MG;300MG FDA marketing: Discontinued	2021 DISQUALIFIED FINAL	0
LAMIVUDINE; ZIDOVUDINE LAMIVUDINE AND ZIDOVUDINE	022018 Product 022018/001	TABLET · ORAL 150MG;300MG FDA marketing: Discontinued	DISCONTINUED FINAL	0
LAMOTRIGINE LAMICTAL XR	022115 Product 022115/001	TABLET, EXTENDED RELEASE · ORAL 25MG FDA marketing: Prescription	2012 EXISTING_GENERIC DISQUALIFIED	1
LAMOTRIGINE LAMICTAL XR	022115 Product 022115/002	TABLET, EXTENDED RELEASE · ORAL 50MG FDA marketing: Prescription	2012 EXISTING_GENERIC DISQUALIFIED	1
LAMOTRIGINE LAMICTAL XR	022115 Product 022115/003	TABLET, EXTENDED RELEASE · ORAL 100MG FDA marketing: Prescription	2012 EXISTING_GENERIC DISQUALIFIED	1
LAMOTRIGINE LAMICTAL XR	022115 Product 022115/004	TABLET, EXTENDED RELEASE · ORAL 200MG FDA marketing: Prescription	2012 EXISTING_GENERIC DISQUALIFIED	1
LAMOTRIGINE LAMICTAL XR	022115 Product 022115/005	TABLET, EXTENDED RELEASE · ORAL 300MG FDA marketing: Prescription	2012 EXISTING_GENERIC DISQUALIFIED	1
LAMOTRIGINE LAMICTAL XR	022115 Product 022115/006	TABLET, EXTENDED RELEASE · ORAL 250MG FDA marketing: Prescription	2012 EXISTING_GENERIC DISQUALIFIED	1
LAMOTRIGINE SUBVENITE	218879 Product 218879/001	SUSPENSION · ORAL 10MG/ML FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	4
LAMOTRIGINE HEMIFUMARATE LAMLIQUE	221109 Product 221109/001	SUSPENSION · ORAL EQ 5MG BASE/ML FDA marketing: Prescription	Master only	1
LAMOTRIGINE HEMIFUMARATE LAMLIQUE	221109 Product 221109/002	SUSPENSION · ORAL EQ 25MG BASE/ML FDA marketing: Prescription	Master only	1
lanadelumab-flyo Takhzyro	761090 Product 761090/001	Injection · Subcutaneous 300MG/2ML (150MG/ML) Single-Dose Vial FDA marketing: Prescription	2026 DISCONTINUED FINAL	0
lanadelumab-flyo Takhzyro	761090 Product 761090/002	Injection · Subcutaneous 300MG/2ML (150MG/ML) Pre-Filled Syringe FDA marketing: Prescription	2032 CANDIDATE FINAL_CHECKING	1
LANDIOLOL HYDROCHLORIDE RAPIBLYK	217202 Product 217202/001	POWDER · INTRAVENOUS EQ 280MG BASE/VIAL FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	1
LANREOTIDE ACETATE LANREOTIDE ACETATE	215395 Product 215395/001	SOLUTION · SUBCUTANEOUS EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) FDA marketing: Discontinued	2021 DEEP_REVIEW FINAL	0
LANREOTIDE ACETATE LANREOTIDE ACETATE	215395 Product 215395/002	SOLUTION · SUBCUTANEOUS EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) FDA marketing: Discontinued	2021 DEEP_REVIEW FINAL	0
LANREOTIDE ACETATE LANREOTIDE ACETATE	215395 Product 215395/003	SOLUTION · SUBCUTANEOUS EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) FDA marketing: Discontinued	2021 DEEP_REVIEW FINAL	0
LANREOTIDE ACETATE LANREOTIDE ACETATE	218217 Product 218217/001	SOLUTION · SUBCUTANEOUS EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) FDA marketing: Prescription	Master only	0
LANSOPRAZOLE LANSOPRAZOLE	208025 Product 208025/001	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE · ORAL 15MG FDA marketing: Over-the-counter	2016 EXCLUDED FINAL	2
LANTHANUM CARBONATE FOSRENOL	204734 Product 204734/001	POWDER · ORAL EQ 750MG BASE FDA marketing: Prescription	2018 DEEP_REVIEW FINAL_CHECKING	2
LANTHANUM CARBONATE FOSRENOL	204734 Product 204734/002	POWDER · ORAL EQ 1GM BASE FDA marketing: Prescription	2018 DEEP_REVIEW FINAL_CHECKING	2
LAROTRECTINIB SULFATE VITRAKVI	210861 Product 210861/001	CAPSULE · ORAL EQ 25MG BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	15
LAROTRECTINIB SULFATE VITRAKVI	210861 Product 210861/002	CAPSULE · ORAL EQ 100MG BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	15
LAROTRECTINIB SULFATE VITRAKVI	211710 Product 211710/001	SOLUTION · ORAL EQ 20MG BASE/ML FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	18
LASMIDITAN SUCCINATE REYVOW	211280 Product 211280/001	TABLET · ORAL EQ 50MG BASE FDA marketing: Discontinued	Master only	4
LASMIDITAN SUCCINATE REYVOW	211280 Product 211280/002	TABLET · ORAL EQ 100MG BASE FDA marketing: Discontinued	Master only	4
LASMIDITAN SUCCINATE REYVOW	211280 Product 211280/003	TABLET · ORAL EQ 200MG BASE FDA marketing: Discontinued	Master only	3
LATANOPROST IYUZEH	216472 Product 216472/001	SOLUTION/DROPS · OPHTHALMIC 0.005% FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	1
LATANOPROST XELPROS	206185 Product 206185/001	EMULSION · OPHTHALMIC 0.005% FDA marketing: Discontinued	2024 DISCONTINUED FINAL	2
LATANOPROST; NETARSUDIL DIMESYLATE ROCKLATAN	208259 Product 208259/001	SOLUTION/DROPS · OPHTHALMIC 0.005%;EQ 0.02% BASE FDA marketing: Prescription	2034 CANDIDATE FINAL	17
LATANOPROSTENE BUNOD VYZULTA	207795 Product 207795/001	SOLUTION/DROPS · OPHTHALMIC 0.024% FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
LAZERTINIB MESYLATE LAZCLUZE	219008 Product 219008/001	TABLET · ORAL EQ 80MG BASE FDA marketing: Prescription	2041 CANDIDATE FINAL	9
LAZERTINIB MESYLATE LAZCLUZE	219008 Product 219008/002	TABLET · ORAL EQ 240MG BASE FDA marketing: Prescription	2041 CANDIDATE FINAL	9
lebrikizumab-lbkz Ebglyss	761306 Product 761306/001	Injection · Subcutaneous 250MG/2ML Autoinjector FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	9
lecanemab-irmb Leqembi	761269 Product 761269/001	Injection · Intravenous 200MG/2ML (100MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	1
lecanemab-irmb Leqembi	761269 Product 761269/002	Injection · Intravenous 500MG/5ML (100MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	1
lecanemab-irmb Leqembi IQLIK	761375 Product 761375/001	Injection · Subcutaneous 360MG/1.8ML (200MG/ML) Autoinjector FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	1
LEDIPASVIR; SOFOSBUVIR HARVONI	205834 Product 205834/001	TABLET · ORAL 90MG;400MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	17
LEDIPASVIR; SOFOSBUVIR HARVONI	205834 Product 205834/002	TABLET · ORAL 45MG;200MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	17
LEDIPASVIR; SOFOSBUVIR HARVONI	212477 Product 212477/001	PELLETS · ORAL 33.75MG/PACKET;150MG/PACKET FDA marketing: Prescription	2033 CANDIDATE FINAL	16
LEDIPASVIR; SOFOSBUVIR HARVONI	212477 Product 212477/002	PELLETS · ORAL 45MG/PACKET;200MG/PACKET FDA marketing: Prescription	2033 CANDIDATE FINAL	16
LEFAMULIN ACETATE XENLETA	211672 Product 211672/001	TABLET · ORAL EQ 600MG BASE FDA marketing: Prescription	2033 CANDIDATE FINAL	3
LEFAMULIN ACETATE XENLETA	211673 Product 211673/001	SOLUTION · INTRAVENOUS EQ 150MG BASE/15ML (EQ 10MG BASE/ML) FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	3
LEMBOREXANT DAYVIGO	212028 Product 212028/001	TABLET · ORAL 5MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	4
LEMBOREXANT DAYVIGO	212028 Product 212028/002	TABLET · ORAL 10MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	4
LENACAPAVIR SODIUM SUNLENCA	215973 Product 215973/001	SOLUTION · SUBCUTANEOUS EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	6
LENACAPAVIR SODIUM SUNLENCA	215974 Product 215974/001	TABLET · ORAL EQ 300MG BASE FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	5
LENACAPAVIR SODIUM YEZTUGO	220018 Product 220018/001	SOLUTION · SUBCUTANEOUS EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) FDA marketing: Prescription	2040 CANDIDATE FINAL	5
LENACAPAVIR SODIUM YEZTUGO	220020 Product 220020/001	TABLET · ORAL EQ 300MG BASE FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	3
LENALIDOMIDE REVLIMID	021880 Product 021880/005	CAPSULE · ORAL 2.5MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	2
LENALIDOMIDE REVLIMID	021880 Product 021880/006	CAPSULE · ORAL 20MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	2
LENIOLISIB PHOSPHATE JOENJA	217759 Product 217759/001	TABLET · ORAL EQ 70MG BASE FDA marketing: Prescription	2032 CANDIDATE FINAL	1
LENIOLISIB PHOSPHATE JOENJA	217759 Product 217759/002	TABLET · ORAL EQ 40MG BASE FDA marketing: Prescription	2033 CANDIDATE FINAL	1
LENIOLISIB PHOSPHATE JOENJA	217759 Product 217759/003	TABLET · ORAL EQ 50MG BASE FDA marketing: Prescription	2033 CANDIDATE FINAL	1
LENVATINIB MESYLATE LENVIMA	206947 Product 206947/001	CAPSULE · ORAL EQ 4MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	10
LENVATINIB MESYLATE LENVIMA	206947 Product 206947/002	CAPSULE · ORAL EQ 10MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	10
lerodalcibep-liga Lerochol	761427 Product 761427/001	Injection · Subcutaneous 300MG/1.2ML (250MG/ML) Pre-Filled Syringe FDA marketing: Prescription	2039 CANDIDATE FINAL_CHECKING	2
LESINURAD ZURAMPIC	207988 Product 207988/001	TABLET · ORAL 200MG FDA marketing: DISCONTINUED	2019 DISQUALIFIED FINAL	8
LETERMOVIR PREVYMIS	209939 Product 209939/001	TABLET · ORAL 240MG FDA marketing: RX	2029 DEEP_REVIEW FINAL	1
LETERMOVIR PREVYMIS	209939 Product 209939/002	TABLET · ORAL 480MG FDA marketing: RX	2029 DEEP_REVIEW FINAL	1
LETERMOVIR PREVYMIS	209940 Product 209940/001	SOLUTION · INTRAVENOUS 240MG/12ML (20MG/ML) FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	2
LETERMOVIR PREVYMIS	209940 Product 209940/002	SOLUTION · INTRAVENOUS 480MG/24ML (20MG/ML) FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	2
LETERMOVIR PREVYMIS	219104 Product 219104/001	PELLETS · ORAL 20MG/PACKET FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	1
LETERMOVIR PREVYMIS	219104 Product 219104/002	PELLETS · ORAL 120MG/PACKET FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	1
LETIBOTULINUMTOXINA-WLBG LETYBO	761225 Product 761225/001	POWDER, FOR SOLUTION 0.1ML(4UNITS) FDA marketing: Prescription	Master only	0
LETROZOLE LETROZOLE	220438 Product 220438/001	TABLET · ORAL 2.5MG FDA marketing: Prescription	Master only	0
LETROZOLE; RIBOCICLIB SUCCINATE KISQALI FEMARA CO-PACK (COPACKAGED)	209935 Product 209935/001	TABLET · ORAL 2.5MG;EQ 200MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	11
LEUCOVORIN CALCIUM VYKOURA	220406 Product 220406/001	SOLUTION · INTRAMUSCULAR, INTRAVENOUS EQ 50MG BASE/5ML (EQ 10MG BASE/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	1
LEUCOVORIN CALCIUM VYKOURA	220406 Product 220406/002	SOLUTION · INTRAMUSCULAR, INTRAVENOUS EQ 350MG BASE/35ML (EQ 10MG BASE/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	1
LEUCOVORIN CALCIUM VYKOURA	220406 Product 220406/003	SOLUTION · INTRAMUSCULAR, INTRAVENOUS EQ 500MG BASE/50ML (EQ 10MG BASE/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	1
LEUPROLIDE ACETATE FENSOLVI KIT	213150 Product 213150/001	POWDER · SUBCUTANEOUS 45MG FDA marketing: Prescription	Master only	3
LEUPROLIDE ACETATE LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	205054 Product 205054/001	FOR SUSPENSION · INTRAMUSCULAR 22.5MG/VIAL FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	1
LEUPROLIDE ACETATE LUPRON DEPOT	020517 Product 020517/003	INJECTABLE · INJECTION 45MG FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	2
LEUPROLIDE ACETATE LUPRON DEPOT-PED KIT	020263 Product 020263/007	POWDER · INTRAMUSCULAR 11.25MG FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	4
LEUPROLIDE ACETATE LUPRON DEPOT-PED KIT	020263 Product 020263/008	POWDER · INTRAMUSCULAR 30MG FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	6
LEUPROLIDE ACETATE LUPRON DEPOT-PED KIT	020263 Product 020263/009	POWDER · INTRAMUSCULAR 45MG FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	2
LEUPROLIDE ACETATE VOBRIG	213225 Product 213225/001	SOLUTION · SUBCUTANEOUS 28MG/2.8ML (10MG/ML) FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	0
LEUPROLIDE ACETATE; NORETHINDRONE ACETATE LUPANETA PACK	203696 Product 203696/001	INJECTABLE, TABLET · INTRAMUSCULAR, ORAL 3.75MG/VIAL,N/A;N/A,5MG FDA marketing: Discontinued	2024 WITHDRAWN FINAL	1
LEUPROLIDE ACETATE; NORETHINDRONE ACETATE LUPANETA PACK	203696 Product 203696/002	INJECTABLE, TABLET · INTRAMUSCULAR, ORAL 11.25MG/VIAL,N/A;N/A,5MG FDA marketing: Discontinued	2024 WITHDRAWN FINAL	1
LEUPROLIDE MESYLATE CAMCEVI ETM	219745 Product 219745/001	EMULSION · SUBCUTANEOUS EQ 21MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	5
LEUPROLIDE MESYLATE CAMCEVI KIT	211488 Product 211488/001	EMULSION · SUBCUTANEOUS EQ 42MG BASE FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	5
LEVACETYLLEUCINE AQNEURSA	219132 Product 219132/001	FOR SUSPENSION · ORAL 1GM/PACKET FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	4
LEVAMLODIPINE MALEATE CONJUPRI	212895 Product 212895/001	TABLET · ORAL EQ 1.25MG BASE FDA marketing: Discontinued	2020 DISQUALIFIED FINAL	0
LEVAMLODIPINE MALEATE CONJUPRI	212895 Product 212895/002	TABLET · ORAL EQ 2.5MG BASE FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	0
LEVAMLODIPINE MALEATE CONJUPRI	212895 Product 212895/003	TABLET · ORAL EQ 5MG BASE FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	0
LEVETIRACETAM ELEPSIA XR	204417 Product 204417/001	TABLET, EXTENDED RELEASE · ORAL 1GM FDA marketing: Discontinued	2023 DISCONTINUED FINAL	5
LEVETIRACETAM ELEPSIA XR	204417 Product 204417/002	TABLET, EXTENDED RELEASE · ORAL 1.5GM FDA marketing: Discontinued	2023 DISCONTINUED FINAL	5
LEVETIRACETAM LEVETIRACETAM IN SODIUM CHLORIDE	202543 Product 202543/001	INJECTABLE · INTRAVENOUS 500MG/100ML (5MG/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
LEVETIRACETAM LEVETIRACETAM IN SODIUM CHLORIDE	202543 Product 202543/002	INJECTABLE · INTRAVENOUS 1GM/100ML (10MG/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
LEVETIRACETAM LEVETIRACETAM IN SODIUM CHLORIDE	202543 Product 202543/003	INJECTABLE · INTRAVENOUS 1.5GM/100ML (15MG/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
LEVETIRACETAM LEVETIRACETAM IN SODIUM CHLORIDE	202543 Product 202543/004	INJECTABLE · INTRAVENOUS 250MG/50ML (5MG/ML) FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	0
LEVETIRACETAM SPRITAM	207958 Product 207958/001	TABLET, FOR SUSPENSION · ORAL 250MG FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	3
LEVETIRACETAM SPRITAM	207958 Product 207958/002	TABLET, FOR SUSPENSION · ORAL 500MG FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	3
LEVETIRACETAM SPRITAM	207958 Product 207958/003	TABLET, FOR SUSPENSION · ORAL 750MG FDA marketing: Discontinued	2025 DISCONTINUED FINAL	3
LEVETIRACETAM SPRITAM	207958 Product 207958/004	TABLET, FOR SUSPENSION · ORAL 1GM FDA marketing: Discontinued	2025 DISCONTINUED FINAL	3
LEVOCARNITINE LEVOCARNITINE	220181 Product 220181/001	INJECTABLE · INJECTION 200MG/ML FDA marketing: Prescription	Master only	0
LEVOCETIRIZINE DIHYDROCHLORIDE XYZAL ALLERGY 24HR	209089 Product 209089/001	TABLET · ORAL 5MG FDA marketing: Over-the-counter	2017 EXCLUDED FINAL	0
LEVOCETIRIZINE DIHYDROCHLORIDE XYZAL ALLERGY 24HR	209090 Product 209090/001	SOLUTION · ORAL 2.5MG/5ML FDA marketing: Over-the-counter	2017 EXCLUDED FINAL	1
LEVODOPA INBRIJA	209184 Product 209184/001	POWDER · INHALATION 42MG FDA marketing: Prescription	2029 DEEP_REVIEW FINAL_CHECKING	6
LEVOKETOCONAZOLE RECORLEV	214133 Product 214133/001	TABLET · ORAL 150MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	9
LEVOLEUCOVORIN KHAPZORY	211226 Product 211226/001	POWDER · INTRAVENOUS 175MG/VIAL FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	1
LEVOLEUCOVORIN KHAPZORY	211226 Product 211226/002	POWDER · INTRAVENOUS 300MG/VIAL FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
LEVOLEUCOVORIN CALCIUM FUSILEV	020140 Product 020140/002	SOLUTION · INTRAVENOUS EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) FDA marketing: Discontinued	2026 WITHDRAWN FINAL	1
LEVOLEUCOVORIN CALCIUM FUSILEV	020140 Product 020140/003	SOLUTION · INTRAVENOUS EQ 250MG BASE/25ML (EQ 10MG BASE/ML) FDA marketing: Discontinued	2026 WITHDRAWN FINAL	1
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM	208723 Product 208723/001	POWDER · INTRAVENOUS EQ 175MG BASE/VIAL FDA marketing: Discontinued	2019 DISCONTINUED FINAL	0
LEVOMILNACIPRAN HYDROCHLORIDE FETZIMA	204168 Product 204168/001	CAPSULE, EXTENDED RELEASE · ORAL EQ 20MG BASE FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	3
LEVOMILNACIPRAN HYDROCHLORIDE FETZIMA	204168 Product 204168/002	CAPSULE, EXTENDED RELEASE · ORAL EQ 40MG BASE FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	3
LEVOMILNACIPRAN HYDROCHLORIDE FETZIMA	204168 Product 204168/003	CAPSULE, EXTENDED RELEASE · ORAL EQ 80MG BASE FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	3
LEVOMILNACIPRAN HYDROCHLORIDE FETZIMA	204168 Product 204168/004	CAPSULE, EXTENDED RELEASE · ORAL EQ 120MG BASE FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	3
LEVONORGESTREL KYLEENA	208224 Product 208224/001	SYSTEM · INTRAUTERINE 19.5MG FDA marketing: Prescription	2019 DEEP_REVIEW FINAL_CHECKING	3
LEVONORGESTREL LILETTA	206229 Product 206229/001	SYSTEM · INTRAUTERINE 52MG FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	4
LEVONORGESTREL SKYLA	203159 Product 203159/001	SYSTEM · INTRAUTERINE 13.5MG FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	3
LEVOTHYROXINE SODIUM ERMEZA	215809 Product 215809/001	SOLUTION · ORAL 150MCG/5ML FDA marketing: Discontinued	2026 DISCONTINUED FINAL	1
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM	202231 Product 202231/001	POWDER · INTRAVENOUS 100MCG/VIAL FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	3
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM	202231 Product 202231/002	POWDER · INTRAVENOUS 200MCG/VIAL FDA marketing: Prescription	2015 EXISTING_GENERIC DISQUALIFIED	3
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM	202231 Product 202231/003	POWDER · INTRAVENOUS 500MCG/VIAL FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	3
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM	210632 Product 210632/001	SOLUTION · INTRAVENOUS 100MCG/5ML (20MCG/ML) FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	4
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM	210632 Product 210632/002	SOLUTION · INTRAVENOUS 200MCG/5ML (40MCG/ML) FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	4
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM	210632 Product 210632/003	SOLUTION · INTRAVENOUS 500MCG/5ML (100MCG/ML) FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	4
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM	214253 Product 214253/001	SOLUTION · INTRAVENOUS 100MCG/ML FDA marketing: Discontinued	2026 DISCONTINUED FINAL	1
LEVOTHYROXINE SODIUM THYQUIDITY	214047 Product 214047/001	SOLUTION · ORAL 100MCG/5ML FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	1
LEVOTHYROXINE SODIUM TIROSINT	021924 Product 021924/011	CAPSULE · ORAL 0.175MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	1
LEVOTHYROXINE SODIUM TIROSINT	021924 Product 021924/012	CAPSULE · ORAL 0.2MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	1
LEVOTHYROXINE SODIUM TIROSINT	021924 Product 021924/014	CAPSULE · ORAL 0.0375MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	1
LEVOTHYROXINE SODIUM TIROSINT	021924 Product 021924/015	CAPSULE · ORAL 0.044MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	1
LEVOTHYROXINE SODIUM TIROSINT	021924 Product 021924/016	CAPSULE · ORAL 0.0625MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	1
LEVOTHYROXINE SODIUM TIROSINT-SOL	206977 Product 206977/001	SOLUTION · ORAL 13MCG/ML FDA marketing: Prescription	2016 DEEP_REVIEW FINAL_CHECKING	4
LEVOTHYROXINE SODIUM TIROSINT-SOL	206977 Product 206977/002	SOLUTION · ORAL 25MCG/ML FDA marketing: Prescription	2016 DEEP_REVIEW FINAL_CHECKING	4
LEVOTHYROXINE SODIUM TIROSINT-SOL	206977 Product 206977/003	SOLUTION · ORAL 50MCG/ML FDA marketing: Prescription	2016 DEEP_REVIEW FINAL_CHECKING	4
LEVOTHYROXINE SODIUM TIROSINT-SOL	206977 Product 206977/004	SOLUTION · ORAL 75MCG/ML FDA marketing: Prescription	2016 DEEP_REVIEW FINAL_CHECKING	4
LEVOTHYROXINE SODIUM TIROSINT-SOL	206977 Product 206977/005	SOLUTION · ORAL 88MCG/ML FDA marketing: Prescription	2016 DEEP_REVIEW FINAL_CHECKING	4
LEVOTHYROXINE SODIUM TIROSINT-SOL	206977 Product 206977/006	SOLUTION · ORAL 100MCG/ML FDA marketing: Prescription	2016 DEEP_REVIEW FINAL_CHECKING	4
LEVOTHYROXINE SODIUM TIROSINT-SOL	206977 Product 206977/007	SOLUTION · ORAL 112MCG/ML FDA marketing: Prescription	2016 DEEP_REVIEW FINAL_CHECKING	4
LEVOTHYROXINE SODIUM TIROSINT-SOL	206977 Product 206977/008	SOLUTION · ORAL 125MCG/ML FDA marketing: Prescription	2016 DEEP_REVIEW FINAL_CHECKING	4
LEVOTHYROXINE SODIUM TIROSINT-SOL	206977 Product 206977/009	SOLUTION · ORAL 137MCG/ML FDA marketing: Prescription	2016 DEEP_REVIEW FINAL_CHECKING	4
LEVOTHYROXINE SODIUM TIROSINT-SOL	206977 Product 206977/010	SOLUTION · ORAL 150MCG/ML FDA marketing: Prescription	2016 DEEP_REVIEW FINAL_CHECKING	4
LEVOTHYROXINE SODIUM TIROSINT-SOL	206977 Product 206977/011	SOLUTION · ORAL 175MCG/ML FDA marketing: Prescription	2016 DEEP_REVIEW FINAL_CHECKING	4
LEVOTHYROXINE SODIUM TIROSINT-SOL	206977 Product 206977/012	SOLUTION · ORAL 200MCG/ML FDA marketing: Prescription	2016 DEEP_REVIEW FINAL_CHECKING	4
LEVOTHYROXINE SODIUM TIROSINT-SOL	206977 Product 206977/013	SOLUTION · ORAL 37.5MCG/ML FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	4
LEVOTHYROXINE SODIUM TIROSINT-SOL	206977 Product 206977/014	SOLUTION · ORAL 44MCG/ML FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	4
LEVOTHYROXINE SODIUM TIROSINT-SOL	206977 Product 206977/015	SOLUTION · ORAL 62.5MCG/ML FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	4
LIDOCAINE BONDLIDO	215029 Product 215029/001	SYSTEM · TOPICAL 10% FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	1
LIDOCAINE ZTLIDO	207962 Product 207962/001	PATCH · TOPICAL 1.8% FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	8
LIFITEGRAST XIIDRA	208073 Product 208073/001	SOLUTION/DROPS · OPHTHALMIC 5% FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	11
LINACLOTIDE LINACLOTIDE	211255 Product 211255/001	CAPSULE · ORAL 72MCG FDA marketing: Prescription	Master only	0
LINACLOTIDE LINZESS	202811 Product 202811/001	CAPSULE · ORAL 145MCG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	5
LINACLOTIDE LINZESS	202811 Product 202811/002	CAPSULE · ORAL 290MCG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	5
LINACLOTIDE LINZESS	202811 Product 202811/003	CAPSULE · ORAL 72MCG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	10
LINAGLIPTIN TRADJENTA	201280 Product 201280/001	TABLET · ORAL 5MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	10
LINAGLIPTIN; METFORMIN HYDROCHLORIDE JENTADUETO	201281 Product 201281/001	TABLET · ORAL 2.5MG;500MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	10
LINAGLIPTIN; METFORMIN HYDROCHLORIDE JENTADUETO	201281 Product 201281/002	TABLET · ORAL 2.5MG;850MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	10
LINAGLIPTIN; METFORMIN HYDROCHLORIDE JENTADUETO	201281 Product 201281/003	TABLET · ORAL 2.5MG;1GM FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	10
LINAGLIPTIN; METFORMIN HYDROCHLORIDE JENTADUETO XR	208026 Product 208026/001	TABLET, EXTENDED RELEASE · ORAL 2.5MG;1GM FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	10
LINAGLIPTIN; METFORMIN HYDROCHLORIDE JENTADUETO XR	208026 Product 208026/002	TABLET, EXTENDED RELEASE · ORAL 5MG;1GM FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	10
LINERIXIBAT LYNAVOY	220295 Product 220295/001	TABLET · ORAL 40MG FDA marketing: Prescription	2033 CANDIDATE FINAL	1
LINEZOLID LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	206473 Product 206473/001	SOLUTION · INTRAVENOUS 600MG/300ML (2MG/ML) FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	0
linvoseltamab-gcpt Lynozyfic	761400 Product 761400/001	Injection · Intravenous 5MG/2.5ML (2MG/ML) Single-Dose Vial FDA marketing: Prescription	2040 CANDIDATE FINAL_CHECKING	1
LIRAFUGRATINIB HYDROCHLORIDE LYRFIGTU	220425 Product 220425/001	CAPSULE · ORAL 20MG FDA marketing: Prescription	2040 DEEP_REVIEW FINAL	2
LIRAFUGRATINIB HYDROCHLORIDE LYRFIGTU	220425 Product 220425/002	CAPSULE · ORAL 30MG FDA marketing: Prescription	2040 DEEP_REVIEW FINAL	2
LIRAGLUTIDE SAXENDA	206321 Product 206321/001	SOLUTION · SUBCUTANEOUS 18MG/3ML (6MG/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	2
LIRAGLUTIDE VICTOZA	022341 Product 022341/001	SOLUTION · SUBCUTANEOUS 18MG/3ML (6MG/ML) FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	2
LISDEXAMFETAMINE DIMESYLATE ARYNTA	219847 Product 219847/001	SOLUTION · ORAL 10MG/ML FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	3
LISDEXAMFETAMINE DIMESYLATE VYVANSE	021977 Product 021977/007	CAPSULE · ORAL 10MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
LISDEXAMFETAMINE DIMESYLATE VYVANSE	208510 Product 208510/001	TABLET, CHEWABLE · ORAL 10MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
LISDEXAMFETAMINE DIMESYLATE VYVANSE	208510 Product 208510/002	TABLET, CHEWABLE · ORAL 20MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
LISDEXAMFETAMINE DIMESYLATE VYVANSE	208510 Product 208510/003	TABLET, CHEWABLE · ORAL 30MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
LISDEXAMFETAMINE DIMESYLATE VYVANSE	208510 Product 208510/004	TABLET, CHEWABLE · ORAL 40MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
LISDEXAMFETAMINE DIMESYLATE VYVANSE	208510 Product 208510/005	TABLET, CHEWABLE · ORAL 50MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
LISDEXAMFETAMINE DIMESYLATE VYVANSE	208510 Product 208510/006	TABLET, CHEWABLE · ORAL 60MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
LISINOPRIL QBRELIS	208401 Product 208401/001	SOLUTION · ORAL 1MG/ML FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	12
lixisenatide Adlyxin	208471 Product 208471/001	Injection · Subcutaneous 150MCG/3ML (50MCG/ML) Autoinjector FDA marketing: Prescription	2026 WITHDRAWN FINAL	0
lixisenatide Adlyxin	208471 Product 208471/002	Injection · Subcutaneous 300MCG/3ML (100MCG/ML) Autoinjector FDA marketing: Prescription	2026 WITHDRAWN FINAL	0
LOFEXIDINE HYDROCHLORIDE LUCEMYRA	209229 Product 209229/001	TABLET · ORAL EQ 0.18MG BASE FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
LOMITAPIDE MESYLATE JUXTAPID	203858 Product 203858/001	CAPSULE · ORAL EQ 5MG BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	2
LOMITAPIDE MESYLATE JUXTAPID	203858 Product 203858/002	CAPSULE · ORAL EQ 10MG BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	2
LOMITAPIDE MESYLATE JUXTAPID	203858 Product 203858/003	CAPSULE · ORAL EQ 20MG BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	2
LOMITAPIDE MESYLATE JUXTAPID	203858 Product 203858/004	CAPSULE · ORAL EQ 30MG BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	2
LOMITAPIDE MESYLATE JUXTAPID	203858 Product 203858/005	CAPSULE · ORAL EQ 40MG BASE FDA marketing: Discontinued	2020 DISCONTINUED FINAL	1
LOMITAPIDE MESYLATE JUXTAPID	203858 Product 203858/006	CAPSULE · ORAL EQ 60MG BASE FDA marketing: Discontinued	2020 DISCONTINUED FINAL	1
LOMITAPIDE MESYLATE JUXTAPID	203858 Product 203858/007	CAPSULE · ORAL EQ 2MG BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	2
LOMUSTINE GLEOSTINE	017588 Product 017588/004	CAPSULE · ORAL 5MG FDA marketing: Discontinued	2018 DISCONTINUED FINAL	0
LONAFARNIB ZOKINVY	213969 Product 213969/001	CAPSULE · ORAL 50MG FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	1
LONAFARNIB ZOKINVY	213969 Product 213969/002	CAPSULE · ORAL 75MG FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	1
lonapegsomatropin-tcgd Skytrofa	761177 Product 761177/001	For Injection · Subcutaneous 3MG Single-Dose Cartridge FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	36
lonapegsomatropin-tcgd Skytrofa	761177 Product 761177/002	For Injection · Subcutaneous 3.6MG Single-Dose Cartridge FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	36
lonapegsomatropin-tcgd Skytrofa	761177 Product 761177/003	For Injection · Subcutaneous 4.3MG Single-Dose Cartridge FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	36
lonapegsomatropin-tcgd Skytrofa	761177 Product 761177/004	For Injection · Subcutaneous 5.2MG Single-Dose Cartridge FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	36
lonapegsomatropin-tcgd Skytrofa	761177 Product 761177/005	For Injection · Subcutaneous 6.3MG Single-Dose Cartridge FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	36
lonapegsomatropin-tcgd Skytrofa	761177 Product 761177/006	For Injection · Subcutaneous 7.6MG Single-Dose Cartridge FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	36
lonapegsomatropin-tcgd Skytrofa	761177 Product 761177/007	For Injection · Subcutaneous 9.1MG Single-Dose Cartridge FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	36
lonapegsomatropin-tcgd Skytrofa	761177 Product 761177/008	For Injection · Subcutaneous 11MG Single-Dose Cartridge FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	36
lonapegsomatropin-tcgd Skytrofa	761177 Product 761177/009	For Injection · Subcutaneous 13.3MG Single-Dose Cartridge FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	36
loncastuximab tesirine-lpyl Zynlonta	761196 Product 761196/001	For Injection · Intravenous 10MG Single-Dose Vial FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	1
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE	220722 Product 220722/001	CAPSULE · ORAL 2MG FDA marketing: Over-the-counter	Master only	0
LORATADINE CLARITIN	021891 Product 021891/002	TABLET, CHEWABLE · ORAL 10MG FDA marketing: Over-the-counter	2018 EXCLUDED FINAL	0
LORATADINE; PSEUDOEPHEDRINE SULFATE LORATADINE AND PSEUDOEPHEDRINE SULFATE	220432 Product 220432/001	TABLET, EXTENDED RELEASE · ORAL 10MG;240MG FDA marketing: Over-the-counter	Master only	0
LORAZEPAM LOREEV XR	214826 Product 214826/001	CAPSULE, EXTENDED RELEASE · ORAL 1MG FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	1
LORAZEPAM LOREEV XR	214826 Product 214826/002	CAPSULE, EXTENDED RELEASE · ORAL 2MG FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	1
LORAZEPAM LOREEV XR	214826 Product 214826/003	CAPSULE, EXTENDED RELEASE · ORAL 3MG FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	1
LORAZEPAM LOREEV XR	214826 Product 214826/004	CAPSULE, EXTENDED RELEASE · ORAL 1.5MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	1
LORLATINIB LORBRENA	210868 Product 210868/001	TABLET · ORAL 25MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	4
LORLATINIB LORBRENA	210868 Product 210868/002	TABLET · ORAL 100MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	4
LOSARTAN POTASSIUM ARBLI	218772 Product 218772/001	SUSPENSION · ORAL 10MG/ML FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	3
LOTEPREDNOL ETABONATE EYSUVIS	210933 Product 210933/001	SUSPENSION/DROPS · OPHTHALMIC 0.25% FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	17
LOTEPREDNOL ETABONATE INVELTYS	210565 Product 210565/001	SUSPENSION/DROPS · OPHTHALMIC 1% FDA marketing: Discontinued	2021 DEEP_REVIEW FINAL_CHECKING	13
LOTEPREDNOL ETABONATE LOTEMAX	200738 Product 200738/001	OINTMENT · OPHTHALMIC 0.5% FDA marketing: Prescription	2014 CANDIDATE FINAL	0
LOTEPREDNOL ETABONATE LOTEMAX	202872 Product 202872/001	GEL · OPHTHALMIC 0.5% FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
LOTEPREDNOL ETABONATE LOTEMAX SM	208219 Product 208219/001	GEL · OPHTHALMIC 0.38% FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	3
LOTILANER XDEMVY	217603 Product 217603/001	SOLUTION/DROPS · OPHTHALMIC 0.25% FDA marketing: Prescription	2038 CANDIDATE FINAL	9
LOXAPINE ADASUVE	022549 Product 022549/001	POWDER · INHALATION 10MG FDA marketing: Prescription	2015 DEEP_REVIEW FINAL_CHECKING	1
LUBIPROSTONE LUBIPROSTONE	221049 Product 221049/001	CAPSULE · ORAL 8MCG FDA marketing: Prescription	Master only	0
LUBIPROSTONE LUBIPROSTONE	221049 Product 221049/002	CAPSULE · ORAL 24MCG FDA marketing: Prescription	Master only	0
LUCINACTANT SURFAXIN	021746 Product 021746/001	SUSPENSION · INTRATRACHEAL 8.5ML FDA marketing: Discontinued	2015 DISCONTINUED FINAL	1
LULICONAZOLE LUZU	204153 Product 204153/001	CREAM · TOPICAL 1% FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	5
LUMASIRAN SODIUM OXLUMO	214103 Product 214103/001	SOLUTION · SUBCUTANEOUS EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) FDA marketing: Prescription	2041 CANDIDATE FINAL	15
LUMATEPERONE TOSYLATE CAPLYTA	209500 Product 209500/001	CAPSULE · ORAL EQ 42MG BASE FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	23
LUMATEPERONE TOSYLATE CAPLYTA	209500 Product 209500/002	CAPSULE · ORAL EQ 10.5MG BASE FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	19
LUMATEPERONE TOSYLATE CAPLYTA	209500 Product 209500/003	CAPSULE · ORAL EQ 21MG BASE FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	18
LURASIDONE HYDROCHLORIDE LATUDA	200603 Product 200603/001	TABLET · ORAL 40MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	6
LURASIDONE HYDROCHLORIDE LATUDA	200603 Product 200603/002	TABLET · ORAL 80MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	6
LURASIDONE HYDROCHLORIDE LATUDA	200603 Product 200603/003	TABLET · ORAL 20MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	6
LURASIDONE HYDROCHLORIDE LATUDA	200603 Product 200603/004	TABLET · ORAL 120MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	6
LURASIDONE HYDROCHLORIDE LATUDA	200603 Product 200603/005	TABLET · ORAL 60MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	6
LURBINECTEDIN ZEPZELCA	213702 Product 213702/001	POWDER · INTRAVENOUS 4MG/VIAL FDA marketing: Prescription	2029 CANDIDATE FINAL	4
luspatercept-aamt Reblozyl	761136 Product 761136/001	For Injection · Subcutaneous 25MG/VIAL Single-Dose Vial FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	0
luspatercept-aamt Reblozyl	761136 Product 761136/002	For Injection · Subcutaneous 75MG/VIAL Single-Dose Vial FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	0
LUSUTROMBOPAG MULPLETA	210923 Product 210923/001	TABLET · ORAL 3MG FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	3
LUTETIUM LU 177 DOTATATE LUTATHERA	208700 Product 208700/001	SOLUTION · INTRAVENOUS 10mCi/ML FDA marketing: Prescription	2026 EXISTING_GENERIC FINAL	9
LUTETIUM LU-177 DOTATATE BEXLUTRY	218525 Product 218525/001	SOLUTION · INTRAVENOUS 10mCi/ML FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
LUTETIUM LU-177 DOTATATE BRAVNETSA	217060 Product 217060/001	SOLUTION · INTRAVENOUS 10mCi/ML FDA marketing: Prescription	Master only	0
LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN PLUVICTO	215833 Product 215833/001	SOLUTION · INTRAVENOUS 27mCi/ML FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	5
MACIMORELIN ACETATE MACRILEN	205598 Product 205598/001	FOR SOLUTION · ORAL EQ 60MG BASE/POUCH FDA marketing: Discontinued	2017 EXCLUDED FINAL	1
MACITENTAN OPSUMIT	204410 Product 204410/001	TABLET · ORAL 10MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	5
MACITENTAN; TADALAFIL OPSYNVI	218490 Product 218490/001	TABLET · ORAL 10MG;20MG FDA marketing: Prescription	2031 CANDIDATE FINAL	3
MACITENTAN; TADALAFIL OPSYNVI	218490 Product 218490/002	TABLET · ORAL 10MG;40MG FDA marketing: Prescription	2031 CANDIDATE FINAL	3
MAGNESIUM SULFATE MAGNESIUM SULFATE	019316 Product 019316/003	SOLUTION · INTRAMUSCULAR, INTRAVENOUS 10GM/20ML (500MG/ML) FDA marketing: Prescription	2015 EXISTING_GENERIC DISQUALIFIED	0
MAGNESIUM SULFATE MAGNESIUM SULFATE	019316 Product 019316/004	SOLUTION · INTRAMUSCULAR, INTRAVENOUS 25GM/50ML (500MG/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE SUCLEAR	203595 Product 203595/001	SOLUTION · ORAL 1.6GM/BOT,3.13GM/BOT,17.5GM/BOT,N/A,N/A,N/A,N/A;N/A,N/A,N/A,210GM,0.74GM,2.86GM,5.6GM FDA marketing: Discontinued	2017 WITHDRAWN FINAL	0
MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE SUFLAVE	215344 Product 215344/001	FOR SOLUTION · ORAL 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	4
MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE SUTAB	213135 Product 213135/001	TABLET · ORAL 0.225GM;0.188GM;1.479GM FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	4
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE COLPREP KIT	204553 Product 204553/001	POWDER · ORAL 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT FDA marketing: Discontinued	2019 WITHDRAWN FINAL	0
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE SUPREP BOWEL PREP KIT	022372 Product 022372/001	SOLUTION · ORAL 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
MANNITOL ARIDOL	022368 Product 022368/002	POWDER · INHALATION 10MG FDA marketing: Prescription	Master only	0
MANNITOL ARIDOL	022368 Product 022368/003	POWDER · INHALATION 20MG FDA marketing: Prescription	Master only	0
MANNITOL ARIDOL	022368 Product 022368/004	POWDER · INHALATION 40MG FDA marketing: Prescription	Master only	0
MANNITOL ARIDOL KIT	022368 Product 022368/001	POWDER · INHALATION N/A,5MG,10MG,20MG,40MG FDA marketing: Prescription	2010 EXCLUDED FINAL	1
MANNITOL BRONCHITOL	202049 Product 202049/001	POWDER · INHALATION 40MG FDA marketing: Prescription	2027 CANDIDATE FINAL	0
MARALIXIBAT CHLORIDE LIVMARLI	214662 Product 214662/001	SOLUTION · ORAL EQ 9.5MG BASE/ML FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	8
MARALIXIBAT CHLORIDE LIVMARLI	214662 Product 214662/002	SOLUTION · ORAL EQ 19MG BASE/ML FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	3
MARALIXIBAT CHLORIDE LIVMARLI	219485 Product 219485/001	TABLET · ORAL EQ 10MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	8
MARALIXIBAT CHLORIDE LIVMARLI	219485 Product 219485/002	TABLET · ORAL EQ 15MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	8
MARALIXIBAT CHLORIDE LIVMARLI	219485 Product 219485/003	TABLET · ORAL EQ 20MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	8
MARALIXIBAT CHLORIDE LIVMARLI	219485 Product 219485/004	TABLET · ORAL EQ 30MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	8
MARAVIROC SELZENTRY	022128 Product 022128/003	TABLET · ORAL 25MG FDA marketing: Discontinued	2024 DISCONTINUED FINAL	4
MARAVIROC SELZENTRY	022128 Product 022128/004	TABLET · ORAL 75MG FDA marketing: Discontinued	2024 DISCONTINUED FINAL	4
MARAVIROC SELZENTRY	208984 Product 208984/001	SOLUTION · ORAL 20MG/ML FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	4
margetuximab-cmkb Margenza	761150 Product 761150/001	Injection · Intravenous 250MG/10ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2034 CANDIDATE FINAL	0
MARIBAVIR LIVTENCITY	215596 Product 215596/001	TABLET · ORAL 200MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	8
MARSTACIMAB-HNCQ HYMPAVZI	761369 Product 761369/001	INJECTABLE · SUBCUTANEOUS 300MG FDA marketing: Prescription	Master only	0
MAVACAMTEN CAMZYOS	214998 Product 214998/001	CAPSULE · ORAL 2.5MG FDA marketing: Prescription	2036 CANDIDATE FINAL	2
MAVACAMTEN CAMZYOS	214998 Product 214998/002	CAPSULE · ORAL 5MG FDA marketing: Prescription	2036 CANDIDATE FINAL	2
MAVACAMTEN CAMZYOS	214998 Product 214998/003	CAPSULE · ORAL 10MG FDA marketing: Prescription	2036 CANDIDATE FINAL	2
MAVACAMTEN CAMZYOS	214998 Product 214998/004	CAPSULE · ORAL 15MG FDA marketing: Prescription	2036 CANDIDATE FINAL	2
MAVACAMTEN CAMZYOS	214998 Product 214998/005	CAPSULE · ORAL 1MG FDA marketing: Prescription	Master only	0
MAVORIXAFOR XOLREMDI	218709 Product 218709/001	CAPSULE · ORAL 100MG FDA marketing: Prescription	2038 DEEP_REVIEW FINAL_CHECKING	6
MEBENDAZOLE VERMOX	208398 Product 208398/001	TABLET, CHEWABLE · ORAL 500MG FDA marketing: Discontinued	2018 DISCONTINUED FINAL	0
MECHLORETHAMINE HYDROCHLORIDE VALCHLOR	202317 Product 202317/001	GEL · TOPICAL EQ 0.016% BASE FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	6
MEDICAL AIR MEDICAL AIR, USP	205711 Product 205711/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	205765 Product 205765/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	205796 Product 205796/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	205803 Product 205803/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	205804 Product 205804/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	205809 Product 205809/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	205821 Product 205821/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	205826 Product 205826/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	205828 Product 205828/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	205845 Product 205845/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	205847 Product 205847/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	205859 Product 205859/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	205890 Product 205890/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	205909 Product 205909/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	205910 Product 205910/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	205992 Product 205992/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	205999 Product 205999/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	207036 Product 207036/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	207114 Product 207114/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	208835 Product 208835/000	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	209927 Product 209927/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	211270 Product 211270/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR MEDICAL AIR, USP	219709 Product 219709/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MEDICAL AIR, USP MEDICAL AIR, USP	221337 Product 221337/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
MELOXICAM ANJESO	210583 Product 210583/001	SOLUTION · INTRAVENOUS 30MG/ML (30MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2023 WITHDRAWN FINAL	5
MELOXICAM MELOXICAM	220010 Product 220010/001	SUSPENSION · ORAL 7.5MG/5ML FDA marketing: Prescription	Master only	0
MELOXICAM QAMZOVA	217593 Product 217593/001	SOLUTION · INTRAVENOUS 30MG/ML (30MG/ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	1
MELOXICAM QMIIZ ODT	211210 Product 211210/001	TABLET, ORALLY DISINTEGRATING · ORAL 7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2020 DISCONTINUED FINAL	1
MELOXICAM QMIIZ ODT	211210 Product 211210/002	TABLET, ORALLY DISINTEGRATING · ORAL 15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2020 DISCONTINUED FINAL	1
MELOXICAM VIVLODEX	207233 Product 207233/001	CAPSULE · ORAL 5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2020 DISCONTINUED FINAL	3
MELOXICAM VIVLODEX	207233 Product 207233/002	CAPSULE · ORAL 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2020 DISCONTINUED FINAL	3
MELOXICAM XIFYRM	218395 Product 218395/001	SOLUTION · INTRAVENOUS 30MG/ML (30MG/ML) FDA marketing: Discontinued	2026 DISCONTINUED FINAL	1
MELOXICAM; RIZATRIPTAN BENZOATE SYMBRAVO	215431 Product 215431/001	TABLET · ORAL 20MG;EQ 10MG BASE FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	96
MELPHALAN HYDROCHLORIDE EVOMELA	207155 Product 207155/001	POWDER · INTRAVENOUS EQ 50MG BASE/VIAL FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	7
MELPHALAN HYDROCHLORIDE HEPZATO	201848 Product 201848/001	POWDER · INTRA-ARTERIAL EQ 50MG BASE/VIAL FDA marketing: Prescription	2030 DEEP_REVIEW FINAL_CHECKING	10
MELPHALAN HYDROCHLORIDE IVRA	217110 Product 217110/001	SOLUTION · INTRAVENOUS EQ 90MG BASE/ML (EQ 90MG BASE/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
MEMANTINE HYDROCHLORIDE NAMENDA XR	022525 Product 022525/001	CAPSULE, EXTENDED RELEASE · ORAL 7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
MEMANTINE HYDROCHLORIDE NAMENDA XR	022525 Product 022525/002	CAPSULE, EXTENDED RELEASE · ORAL 14MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2024 DISCONTINUED FINAL	1
MEMANTINE HYDROCHLORIDE NAMENDA XR	022525 Product 022525/003	CAPSULE, EXTENDED RELEASE · ORAL 21MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2024 DISCONTINUED FINAL	1
MEMANTINE HYDROCHLORIDE NAMENDA XR	022525 Product 022525/004	CAPSULE, EXTENDED RELEASE · ORAL 28MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2024 DISCONTINUED FINAL	1
MENTHOL; METHYL SALICYLATE SALONPAS	022029 Product 022029/002	PATCH · TOPICAL 3%;10% FDA marketing: Over-the-counter	2012 EXCLUDED FINAL	2
mepolizumab Nucala	125526 Product 125526/001	For Injection · Subcutaneous 100MG Single-Dose Vial FDA marketing: Prescription	2027 CANDIDATE FINAL	0
MEPOLIZUMAB NUCALA	761122 Product 761122/001	INJECTABLE · SUBCUTANEOUS 100MG/ML FDA marketing: Prescription	Master only	0
MERCAPTOPURINE PURIXAN	205919 Product 205919/001	SUSPENSION · ORAL 20MG/ML FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
MEROPENEM MEROPENEM	215212 Product 215212/001	POWDER · INTRAVENOUS 2GM/VIAL FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
MEROPENEM MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	202106 Product 202106/001	POWDER · INTRAVENOUS 500MG/VIAL FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	0
MEROPENEM MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	202106 Product 202106/002	POWDER · INTRAVENOUS 1GM/VIAL FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	0
MEROPENEM; VABORBACTAM VABOMERE	209776 Product 209776/001	POWDER · INTRAVENOUS 1GM/VIAL;1GM/VIAL FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
MESALAMINE DELZICOL	204412 Product 204412/001	CAPSULE, DELAYED RELEASE · ORAL 400MG FDA marketing: Discontinued	2025 WITHDRAWN FINAL	3
MESALAMINE MESALAMINE	217736 Product 217736/001	TABLET, DELAYED RELEASE · ORAL 1.2GM FDA marketing: Prescription	Master only	0
METAXALONE METAXALONE	022503 Product 022503/001	TABLET · ORAL 640MG FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	2
METFORMIN HYDROCHLORIDE RIOMET ER	212595 Product 212595/001	FOR SUSPENSION, EXTENDED RELEASE · ORAL 500MG/5ML FDA marketing: Discontinued	2020 DISCONTINUED FINAL	1
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE KOMBIGLYZE XR	200678 Product 200678/001	TABLET, EXTENDED RELEASE · ORAL 500MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2023 DISQUALIFIED FINAL	0
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE KOMBIGLYZE XR	200678 Product 200678/002	TABLET, EXTENDED RELEASE · ORAL 1GM;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2023 DISQUALIFIED FINAL	0
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE KOMBIGLYZE XR	200678 Product 200678/003	TABLET, EXTENDED RELEASE · ORAL 1GM;EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2023 DISQUALIFIED FINAL	0
METFORMIN HYDROCHLORIDE; SITAGLIPTIN ZITUVIMET	216743 Product 216743/001	TABLET · ORAL 500MG;50MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	2
METFORMIN HYDROCHLORIDE; SITAGLIPTIN ZITUVIMET	216743 Product 216743/002	TABLET · ORAL 1GM;50MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	2
METFORMIN HYDROCHLORIDE; SITAGLIPTIN ZITUVIMET XR	216778 Product 216778/001	TABLET, EXTENDED RELEASE · ORAL 500MG;50MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	2
METFORMIN HYDROCHLORIDE; SITAGLIPTIN ZITUVIMET XR	216778 Product 216778/002	TABLET, EXTENDED RELEASE · ORAL 1GM;50MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	2
METFORMIN HYDROCHLORIDE; SITAGLIPTIN ZITUVIMET XR	216778 Product 216778/003	TABLET, EXTENDED RELEASE · ORAL 1GM;100MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	2
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET XR	202270 Product 202270/001	TABLET, EXTENDED RELEASE · ORAL 500MG;EQ 50MG BASE FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET XR	202270 Product 202270/002	TABLET, EXTENDED RELEASE · ORAL 1GM;EQ 50MG BASE FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE JANUMET XR	202270 Product 202270/003	TABLET, EXTENDED RELEASE · ORAL 1GM;EQ 100MG BASE FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
METHACHOLINE CHLORIDE PROVOCHOLINE	019193 Product 019193/002	FOR SOLUTION · INHALATION 1600MG/VIAL FDA marketing: Discontinued	2016 EXCLUDED FINAL	0
METHOCARBAMOL ATMEKSI	219843 Product 219843/001	SUSPENSION · ORAL 750MG/5ML FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	1
METHOHEXITAL SODIUM BREVITAL SODIUM	011559 Product 011559/004	INJECTABLE · INJECTION 200MG/VIAL FDA marketing: Discontinued	2014 DISCONTINUED FINAL	0
METHOTREXATE JYLAMVO	212479 Product 212479/001	SOLUTION · ORAL 2MG/ML FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	3
METHOTREXATE METHOTREXATE	214121 Product 214121/001	SOLUTION · INTRAVENOUS 5GM/50ML (100MG/ML) FDA marketing: Discontinued	2020 DISQUALIFIED FINAL	0
METHOTREXATE OTREXUP	204824 Product 204824/001	SOLUTION · SUBCUTANEOUS 10MG/0.4ML (10MG/0.4ML) FDA marketing: Discontinued	2025 DISCONTINUED FINAL	15
METHOTREXATE OTREXUP	204824 Product 204824/002	SOLUTION · SUBCUTANEOUS 15MG/0.4ML (15MG/0.4ML) FDA marketing: Discontinued	2025 DISCONTINUED FINAL	15
METHOTREXATE OTREXUP	204824 Product 204824/003	SOLUTION · SUBCUTANEOUS 20MG/0.4ML (20MG/0.4ML) FDA marketing: Discontinued	2025 DISCONTINUED FINAL	15
METHOTREXATE OTREXUP	204824 Product 204824/004	SOLUTION · SUBCUTANEOUS 25MG/0.4ML (25MG/0.4ML) FDA marketing: Discontinued	2025 DISCONTINUED FINAL	15
METHOTREXATE OTREXUP	204824 Product 204824/005	SOLUTION · SUBCUTANEOUS 7.5MG/0.4ML (7.5MG/0.4ML) FDA marketing: Discontinued	2016 DISCONTINUED FINAL	15
METHOTREXATE OTREXUP	204824 Product 204824/006	SOLUTION · SUBCUTANEOUS 12.5MG/0.4ML (12.5MG/0.4ML) FDA marketing: Discontinued	2025 DISCONTINUED FINAL	15
METHOTREXATE OTREXUP	204824 Product 204824/007	SOLUTION · SUBCUTANEOUS 17.5MG/0.4ML (17.5MG/0.4ML) FDA marketing: Discontinued	2025 DISCONTINUED FINAL	15
METHOTREXATE OTREXUP	204824 Product 204824/008	SOLUTION · SUBCUTANEOUS 22.5MG/0.4ML (22.5MG/0.4ML) FDA marketing: Discontinued	2025 DISCONTINUED FINAL	15
METHOTREXATE OTREXUP PFS	204824 Product 204824/009	SOLUTION · SUBCUTANEOUS 10MG/0.4ML (10MG/0.4ML) FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
METHOTREXATE OTREXUP PFS	204824 Product 204824/010	SOLUTION · SUBCUTANEOUS 15MG/0.6ML (15MG/0.6ML) FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
METHOTREXATE OTREXUP PFS	204824 Product 204824/011	SOLUTION · SUBCUTANEOUS 17.5MG/0.7ML (17.5MG/0.7ML) FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
METHOTREXATE OTREXUP PFS	204824 Product 204824/012	SOLUTION · SUBCUTANEOUS 20MG/0.8ML (20MG/0.8ML) FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
METHOTREXATE OTREXUP PFS	204824 Product 204824/013	SOLUTION · SUBCUTANEOUS 22.5MG/0.9ML (22.5MG/0.9ML) FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
METHOTREXATE OTREXUP PFS	204824 Product 204824/014	SOLUTION · SUBCUTANEOUS 25MG/ML (25MG/ML) FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
METHOTREXATE RASUVO	205776 Product 205776/001	SOLUTION · SUBCUTANEOUS 7.5MG/0.15ML (7.5MG/0.15ML) FDA marketing: Prescription	2029 CANDIDATE FINAL	1
METHOTREXATE RASUVO	205776 Product 205776/002	SOLUTION · SUBCUTANEOUS 10MG/0.20ML (10MG/0.20ML) FDA marketing: Prescription	2029 CANDIDATE FINAL	1
METHOTREXATE RASUVO	205776 Product 205776/003	SOLUTION · SUBCUTANEOUS 12.5MG/0.25ML (12.5MG/0.25ML) FDA marketing: Prescription	2029 CANDIDATE FINAL	1
METHOTREXATE RASUVO	205776 Product 205776/004	SOLUTION · SUBCUTANEOUS 15MG/0.30ML (15MG/0.30ML) FDA marketing: Prescription	2029 CANDIDATE FINAL	1
METHOTREXATE RASUVO	205776 Product 205776/005	SOLUTION · SUBCUTANEOUS 17.5MG/0.35ML (17.5MG/0.35ML) FDA marketing: Prescription	2029 CANDIDATE FINAL	1
METHOTREXATE RASUVO	205776 Product 205776/006	SOLUTION · SUBCUTANEOUS 20MG/0.4ML (20MG/0.4ML) FDA marketing: Prescription	2029 CANDIDATE FINAL	1
METHOTREXATE RASUVO	205776 Product 205776/007	SOLUTION · SUBCUTANEOUS 22.5MG/0.45ML (22.5MG/0.45ML) FDA marketing: Prescription	2029 CANDIDATE FINAL	1
METHOTREXATE RASUVO	205776 Product 205776/008	SOLUTION · SUBCUTANEOUS 25MG/0.5ML (25MG/0.5ML) FDA marketing: Prescription	2029 CANDIDATE FINAL	1
METHOTREXATE RASUVO	205776 Product 205776/009	SOLUTION · SUBCUTANEOUS 27.5MG/0.55ML (27.5MG/0.55ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2017 DISCONTINUED FINAL	1
METHOTREXATE RASUVO	205776 Product 205776/010	SOLUTION · SUBCUTANEOUS 30MG/0.6ML (30MG/0.6ML) FDA marketing: Prescription	2029 CANDIDATE FINAL	1
METHOTREXATE REDITREX	210737 Product 210737/001	SOLUTION · SUBCUTANEOUS 7.5MG/0.3ML (7.5MG/0.3ML) FDA marketing: Discontinued	2022 DISQUALIFIED FINAL	0
METHOTREXATE REDITREX	210737 Product 210737/002	SOLUTION · SUBCUTANEOUS 10MG/0.4ML (10MG/0.4ML) FDA marketing: Discontinued	2022 DISQUALIFIED FINAL	0
METHOTREXATE REDITREX	210737 Product 210737/003	SOLUTION · SUBCUTANEOUS 12.5MG/0.5ML (12.5MG/0.5ML) FDA marketing: Discontinued	2022 DISQUALIFIED FINAL	0
METHOTREXATE REDITREX	210737 Product 210737/004	SOLUTION · SUBCUTANEOUS 15MG/0.6ML (15MG/0.6ML) FDA marketing: Discontinued	2023 DISQUALIFIED FINAL	0
METHOTREXATE REDITREX	210737 Product 210737/005	SOLUTION · SUBCUTANEOUS 17.5MG/0.7ML (17.5MG/0.7ML) FDA marketing: Discontinued	2022 DISQUALIFIED FINAL	0
METHOTREXATE REDITREX	210737 Product 210737/006	SOLUTION · SUBCUTANEOUS 20MG/0.8ML (20MG/0.8ML) FDA marketing: Discontinued	2023 DISQUALIFIED FINAL	0
METHOTREXATE REDITREX	210737 Product 210737/007	SOLUTION · SUBCUTANEOUS 22.5MG/ML (22.5MG/ML) FDA marketing: Discontinued	2022 DISQUALIFIED FINAL	0
METHOTREXATE REDITREX	210737 Product 210737/008	SOLUTION · SUBCUTANEOUS 25MG/1ML (25MG/1ML) FDA marketing: Discontinued	2023 DISQUALIFIED FINAL	0
METHOTREXATE SODIUM XATMEP	208400 Product 208400/001	SOLUTION · ORAL EQ 2.5MG BASE/ML FDA marketing: Prescription	2024 DEEP_REVIEW FINAL_CHECKING	7
METHYLENE BLUE PROVAYBLUE	204630 Product 204630/001	SOLUTION · INTRAVENOUS 50MG/10ML (5MG/ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
METHYLENE BLUE PROVAYBLUE	204630 Product 204630/002	SOLUTION · INTRAVENOUS 10MG/2ML (5MG/ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
METHYLNALTREXONE BROMIDE RELISTOR	021964 Product 021964/002	SOLUTION · SUBCUTANEOUS 8MG/0.4ML (8MG/0.4ML) FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	6
METHYLNALTREXONE BROMIDE RELISTOR	021964 Product 021964/003	SOLUTION · SUBCUTANEOUS 12MG/0.6ML (12MG/0.6ML) FDA marketing: Prescription	2025 EXISTING_GENERIC COMPLETED	6
METHYLNALTREXONE BROMIDE RELISTOR	208271 Product 208271/001	TABLET · ORAL 150MG FDA marketing: Prescription	2019 DEEP_REVIEW FINAL_CHECKING	9
METHYLPHENIDATE COTEMPLA XR-ODT	205489 Product 205489/001	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL 8.6MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	4
METHYLPHENIDATE COTEMPLA XR-ODT	205489 Product 205489/002	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL 17.3MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	4
METHYLPHENIDATE COTEMPLA XR-ODT	205489 Product 205489/003	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL 25.9MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	4
METHYLPHENIDATE COTEMPLA XR-ODT	205489 Product 205489/004	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL 34.6MG FDA marketing: Discontinued	2025 DISQUALIFIED FINAL	0
METHYLPHENIDATE HYDROCHLORIDE ADHANSIA XR	212038 Product 212038/001	CAPSULE, EXTENDED RELEASE · ORAL 25MG FDA marketing: Discontinued	2023 WITHDRAWN FINAL	12
METHYLPHENIDATE HYDROCHLORIDE ADHANSIA XR	212038 Product 212038/002	CAPSULE, EXTENDED RELEASE · ORAL 35MG FDA marketing: Discontinued	2023 WITHDRAWN FINAL	12
METHYLPHENIDATE HYDROCHLORIDE ADHANSIA XR	212038 Product 212038/003	CAPSULE, EXTENDED RELEASE · ORAL 45MG FDA marketing: Discontinued	2023 WITHDRAWN FINAL	12
METHYLPHENIDATE HYDROCHLORIDE ADHANSIA XR	212038 Product 212038/004	CAPSULE, EXTENDED RELEASE · ORAL 55MG FDA marketing: Discontinued	2023 WITHDRAWN FINAL	12
METHYLPHENIDATE HYDROCHLORIDE ADHANSIA XR	212038 Product 212038/005	CAPSULE, EXTENDED RELEASE · ORAL 70MG FDA marketing: Discontinued	2023 WITHDRAWN FINAL	12
METHYLPHENIDATE HYDROCHLORIDE ADHANSIA XR	212038 Product 212038/006	CAPSULE, EXTENDED RELEASE · ORAL 85MG FDA marketing: Discontinued	2023 WITHDRAWN FINAL	12
METHYLPHENIDATE HYDROCHLORIDE APTENSIO XR	205831 Product 205831/001	CAPSULE, EXTENDED RELEASE · ORAL 10MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
METHYLPHENIDATE HYDROCHLORIDE APTENSIO XR	205831 Product 205831/002	CAPSULE, EXTENDED RELEASE · ORAL 15MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
METHYLPHENIDATE HYDROCHLORIDE APTENSIO XR	205831 Product 205831/003	CAPSULE, EXTENDED RELEASE · ORAL 20MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
METHYLPHENIDATE HYDROCHLORIDE APTENSIO XR	205831 Product 205831/004	CAPSULE, EXTENDED RELEASE · ORAL 30MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
METHYLPHENIDATE HYDROCHLORIDE APTENSIO XR	205831 Product 205831/005	CAPSULE, EXTENDED RELEASE · ORAL 40MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
METHYLPHENIDATE HYDROCHLORIDE APTENSIO XR	205831 Product 205831/006	CAPSULE, EXTENDED RELEASE · ORAL 50MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
METHYLPHENIDATE HYDROCHLORIDE APTENSIO XR	205831 Product 205831/007	CAPSULE, EXTENDED RELEASE · ORAL 60MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
METHYLPHENIDATE HYDROCHLORIDE JORNAY PM	209311 Product 209311/001	CAPSULE, EXTENDED RELEASE · ORAL 20MG FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	16
METHYLPHENIDATE HYDROCHLORIDE JORNAY PM	209311 Product 209311/002	CAPSULE, EXTENDED RELEASE · ORAL 40MG FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	16
METHYLPHENIDATE HYDROCHLORIDE JORNAY PM	209311 Product 209311/003	CAPSULE, EXTENDED RELEASE · ORAL 60MG FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	16
METHYLPHENIDATE HYDROCHLORIDE JORNAY PM	209311 Product 209311/004	CAPSULE, EXTENDED RELEASE · ORAL 80MG FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	16
METHYLPHENIDATE HYDROCHLORIDE JORNAY PM	209311 Product 209311/005	CAPSULE, EXTENDED RELEASE · ORAL 100MG FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	16
METHYLPHENIDATE HYDROCHLORIDE QUILLICHEW ER	207960 Product 207960/001	TABLET, EXTENDED RELEASE, CHEWABLE · ORAL 20MG FDA marketing: RX	2018 DEEP_REVIEW FINAL	10
METHYLPHENIDATE HYDROCHLORIDE QUILLICHEW ER	207960 Product 207960/002	TABLET, EXTENDED RELEASE, CHEWABLE · ORAL 30MG FDA marketing: RX	2018 DEEP_REVIEW FINAL	10
METHYLPHENIDATE HYDROCHLORIDE QUILLICHEW ER	207960 Product 207960/003	TABLET, EXTENDED RELEASE, CHEWABLE · ORAL 40MG FDA marketing: RX	2018 DEEP_REVIEW FINAL	10
METHYLPHENIDATE HYDROCHLORIDE QUILLIVANT XR	202100 Product 202100/001	FOR SUSPENSION, EXTENDED RELEASE · ORAL 5MG/ML FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	7
METHYLPHENIDATE HYDROCHLORIDE RELEXXII	216117 Product 216117/001	TABLET, EXTENDED RELEASE · ORAL 18MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	5
METHYLPHENIDATE HYDROCHLORIDE RELEXXII	216117 Product 216117/002	TABLET, EXTENDED RELEASE · ORAL 27MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	5
METHYLPHENIDATE HYDROCHLORIDE RELEXXII	216117 Product 216117/003	TABLET, EXTENDED RELEASE · ORAL 36MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	5
METHYLPHENIDATE HYDROCHLORIDE RELEXXII	216117 Product 216117/004	TABLET, EXTENDED RELEASE · ORAL 45MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	5
METHYLPHENIDATE HYDROCHLORIDE RELEXXII	216117 Product 216117/005	TABLET, EXTENDED RELEASE · ORAL 54MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	5
METHYLPHENIDATE HYDROCHLORIDE RELEXXII	216117 Product 216117/006	TABLET, EXTENDED RELEASE · ORAL 63MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	5
METHYLPHENIDATE HYDROCHLORIDE RELEXXII	216117 Product 216117/007	TABLET, EXTENDED RELEASE · ORAL 72MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	5
METHYLPHENIDATE HYDROCHLORIDE RITALIN LA	021284 Product 021284/005	CAPSULE, EXTENDED RELEASE · ORAL 60MG FDA marketing: Discontinued	2016 DISCONTINUED FINAL	0
METOCLOPRAMIDE HYDROCHLORIDE GIMOTI	209388 Product 209388/001	SPRAY, METERED · NASAL EQ 15MG BASE/SPRAY FDA marketing: Prescription	2020 DEEP_REVIEW FINAL_CHECKING	7
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE	217072 Product 217072/001	INJECTABLE · INJECTION EQ 5MG BASE/ML FDA marketing: Prescription	Master only	0
METOPROLOL SUCCINATE KAPSPARGO SPRINKLE	210428 Product 210428/001	CAPSULE, EXTENDED RELEASE · ORAL EQ 25MG TARTRATE FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	2
METOPROLOL SUCCINATE KAPSPARGO SPRINKLE	210428 Product 210428/002	CAPSULE, EXTENDED RELEASE · ORAL EQ 50MG TARTRATE FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	2
METOPROLOL SUCCINATE KAPSPARGO SPRINKLE	210428 Product 210428/003	CAPSULE, EXTENDED RELEASE · ORAL EQ 100MG TARTRATE FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	2
METOPROLOL SUCCINATE KAPSPARGO SPRINKLE	210428 Product 210428/004	CAPSULE, EXTENDED RELEASE · ORAL EQ 200MG TARTRATE FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	2
METOPROLOL TARTRATE LOPRESSOR	218698 Product 218698/001	TABLET · ORAL 12.5MG FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
METOPROLOL TARTRATE LOPRESSOR	219373 Product 219373/001	SOLUTION · ORAL 10MG/ML FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
metreleptin Myalept	125390 Product 125390/001	For Injection · Subcutaneous 11.3MG Single-Dose Vial FDA marketing: Prescription	2027 CANDIDATE FINAL	0
METRONIDAZOLE LIKMEZ	216755 Product 216755/001	SUSPENSION · ORAL 500MG/5ML FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	2
METRONIDAZOLE METRONIDAZOLE	218485 Product 218485/001	GEL · VAGINAL 0.75% FDA marketing: Prescription	Master only	0
METRONIDAZOLE NUVESSA	205223 Product 205223/001	GEL · VAGINAL 1.3% FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	7
MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE	214598 Product 214598/001	CAPSULE · ORAL 150MG FDA marketing: Prescription	Master only	0
MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE	214598 Product 214598/002	CAPSULE · ORAL 200MG FDA marketing: Prescription	Master only	0
MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE	214598 Product 214598/003	CAPSULE · ORAL 250MG FDA marketing: Prescription	Master only	0
MICAFUNGIN SODIUM MICAFUNGIN	212125 Product 212125/001	POWDER · INTRAVENOUS EQ 50MG BASE/VIAL FDA marketing: Discontinued	2021 DISQUALIFIED FINAL	3
MICAFUNGIN SODIUM MICAFUNGIN	212125 Product 212125/002	POWDER · INTRAVENOUS EQ 100MG BASE/VIAL FDA marketing: Discontinued	2021 DISQUALIFIED FINAL	3
MICAFUNGIN SODIUM MICAFUNGIN	212156 Product 212156/001	POWDER · INTRAVENOUS EQ 50MG BASE/VIAL FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	3
MICAFUNGIN SODIUM MICAFUNGIN	212156 Product 212156/002	POWDER · INTRAVENOUS EQ 100MG BASE/VIAL FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	3
MICAFUNGIN SODIUM MICAFUNGIN IN SODIUM CHLORIDE 0.9%	216142 Product 216142/001	SOLUTION · INTRAVENOUS EQ 50MG BASE/50ML (EQ 1MG BASE/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
MICAFUNGIN SODIUM MICAFUNGIN IN SODIUM CHLORIDE 0.9%	216142 Product 216142/002	SOLUTION · INTRAVENOUS EQ 100MG BASE/100ML (EQ 1MG BASE/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
MICAFUNGIN SODIUM MICAFUNGIN IN SODIUM CHLORIDE 0.9%	216142 Product 216142/003	SOLUTION · INTRAVENOUS EQ 150MG BASE/150ML (EQ 1MG BASE/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
MICONAZOLE ORAVIG	022404 Product 022404/001	TABLET · BUCCAL 50MG FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	3
MIDAZOLAM MIDAZOLAM IN 0.8% SODIUM CHLORIDE	215868 Product 215868/001	SOLUTION · INTRAVENOUS 50MG/50ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	0
MIDAZOLAM MIDAZOLAM IN 0.8% SODIUM CHLORIDE	215868 Product 215868/002	SOLUTION · INTRAVENOUS 100MG/100ML (1MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
MIDAZOLAM MIDAZOLAM IN 0.9% SODIUM CHLORIDE	211844 Product 211844/001	SOLUTION · INTRAVENOUS 50MG/50ML (1MG/ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	1
MIDAZOLAM MIDAZOLAM IN 0.9% SODIUM CHLORIDE	211844 Product 211844/002	SOLUTION · INTRAVENOUS 100MG/100ML (1MG/ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	1
MIDAZOLAM NAYZILAM	211321 Product 211321/001	SPRAY · NASAL 5MG/SPRAY FDA marketing: Prescription	2028 CANDIDATE FINAL_CHECKING	4
MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	216359 Product 216359/001	SOLUTION · INTRAMUSCULAR EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML) FDA marketing: Prescription	2025 CANDIDATE FINAL	0
MIDAZOLAM HYDROCHLORIDE SEIZALAM	209566 Product 209566/001	SOLUTION · INTRAMUSCULAR EQ 50MG BASE/10ML (EQ 5MG BASE/ML) FDA marketing: Discontinued	2025 DISQUALIFIED FINAL	0
MIDOSTAURIN RYDAPT	207997 Product 207997/001	CAPSULE · ORAL 25MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	2
MIFEPRISTONE KORLYM	202107 Product 202107/001	TABLET · ORAL 300MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	18
MIGALASTAT HYDROCHLORIDE GALAFOLD	208623 Product 208623/001	CAPSULE · ORAL EQ 123MG BASE FDA marketing: Prescription	2038 DEEP_REVIEW FINAL	66
MIGLUSTAT OPFOLDA	215211 Product 215211/001	CAPSULE · ORAL 65MG FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	10
MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE	207399 Product 207399/001	TABLET · ORAL 12.5MG FDA marketing: Prescription	Master only	0
MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE	207399 Product 207399/002	TABLET · ORAL 25MG FDA marketing: Prescription	Master only	0
MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE	207399 Product 207399/003	TABLET · ORAL 50MG FDA marketing: Prescription	Master only	0
MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE	207399 Product 207399/004	TABLET · ORAL 100MG FDA marketing: Prescription	Master only	0
MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE	210944 Product 210944/001	TABLET · ORAL 12.5MG FDA marketing: Prescription	Master only	0
MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE	210944 Product 210944/002	TABLET · ORAL 25MG FDA marketing: Prescription	Master only	0
MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE	210944 Product 210944/003	TABLET · ORAL 50MG FDA marketing: Prescription	Master only	0
MILNACIPRAN HYDROCHLORIDE MILNACIPRAN HYDROCHLORIDE	210944 Product 210944/004	TABLET · ORAL 100MG FDA marketing: Prescription	Master only	0
MILSAPERIDONE BYSANTI	220358 Product 220358/001	TABLET · ORAL 1MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
MILSAPERIDONE BYSANTI	220358 Product 220358/002	TABLET · ORAL 2MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
MILSAPERIDONE BYSANTI	220358 Product 220358/003	TABLET · ORAL 4MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
MILSAPERIDONE BYSANTI	220358 Product 220358/004	TABLET · ORAL 6MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
MILSAPERIDONE BYSANTI	220358 Product 220358/005	TABLET · ORAL 8MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
MILSAPERIDONE BYSANTI	220358 Product 220358/006	TABLET · ORAL 10MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
MILSAPERIDONE BYSANTI	220358 Product 220358/007	TABLET · ORAL 12MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
MILTEFOSINE IMPAVIDO	204684 Product 204684/001	CAPSULE · ORAL 50MG FDA marketing: Prescription	2021 CANDIDATE FINAL	0
MINOCYCLINE HYDROCHLORIDE AMZEEQ	212379 Product 212379/001	AEROSOL, FOAM · TOPICAL EQ 4% BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL_CHECKING	12
MINOCYCLINE HYDROCHLORIDE EMROSI	219015 Product 219015/001	CAPSULE, EXTENDED RELEASE · ORAL EQ 40MG BASE FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	4
MINOCYCLINE HYDROCHLORIDE MINOLIRA	209269 Product 209269/001	TABLET, EXTENDED RELEASE · ORAL EQ 105MG BASE FDA marketing: WITHDRAWN	2026 WITHDRAWN FINAL	1
MINOCYCLINE HYDROCHLORIDE MINOLIRA	209269 Product 209269/002	TABLET, EXTENDED RELEASE · ORAL EQ 135MG BASE FDA marketing: WITHDRAWN	2026 WITHDRAWN FINAL	1
MINOCYCLINE HYDROCHLORIDE SOLODYN	050808 Product 050808/006	TABLET, EXTENDED RELEASE · ORAL EQ 105MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2024 DISCONTINUED FINAL	1
MINOCYCLINE HYDROCHLORIDE SOLODYN	050808 Product 050808/007	TABLET, EXTENDED RELEASE · ORAL EQ 80MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2024 DISCONTINUED FINAL	1
MINOCYCLINE HYDROCHLORIDE SOLODYN	050808 Product 050808/008	TABLET, EXTENDED RELEASE · ORAL EQ 55MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2024 DISCONTINUED FINAL	1
MINOCYCLINE HYDROCHLORIDE XIMINO	201922 Product 201922/001	CAPSULE, EXTENDED RELEASE · ORAL EQ 45MG BASE FDA marketing: Discontinued	2023 DISCONTINUED FINAL	3
MINOCYCLINE HYDROCHLORIDE XIMINO	201922 Product 201922/002	CAPSULE, EXTENDED RELEASE · ORAL EQ 67.5MG BASE FDA marketing: Discontinued	2013 DISCONTINUED FINAL	0
MINOCYCLINE HYDROCHLORIDE XIMINO	201922 Product 201922/003	CAPSULE, EXTENDED RELEASE · ORAL EQ 90MG BASE FDA marketing: Discontinued	2023 DISCONTINUED FINAL	3
MINOCYCLINE HYDROCHLORIDE XIMINO	201922 Product 201922/004	CAPSULE, EXTENDED RELEASE · ORAL EQ 112.5MG BASE FDA marketing: Discontinued	2013 DISCONTINUED FINAL	0
MINOCYCLINE HYDROCHLORIDE XIMINO	201922 Product 201922/005	CAPSULE, EXTENDED RELEASE · ORAL EQ 135MG BASE FDA marketing: Discontinued	2023 DISCONTINUED FINAL	3
MINOCYCLINE HYDROCHLORIDE ZILXI	213690 Product 213690/001	AEROSOL, FOAM · TOPICAL EQ 1.5% BASE FDA marketing: Prescription	2030 CANDIDATE FINAL_CHECKING	10
MINOXIDIL WOMEN'S ROGAINE	021812 Product 021812/002	AEROSOL, FOAM · TOPICAL 5% FDA marketing: Over-the-counter	2014 EXCLUDED FINAL	0
MIPOMERSEN SODIUM KYNAMRO	203568 Product 203568/001	SOLUTION · SUBCUTANEOUS 200MG/ML (200MG/ML) FDA marketing: WITHDRAWN	2019 DISQUALIFIED FINAL	1
MIRABEGRON MIRABEGRON	219599 Product 219599/001	TABLET, EXTENDED RELEASE · ORAL 25MG FDA marketing: Prescription	Master only	0
MIRABEGRON MIRABEGRON	219599 Product 219599/002	TABLET, EXTENDED RELEASE · ORAL 50MG FDA marketing: Prescription	Master only	0
MIRABEGRON MYRBETRIQ	202611 Product 202611/001	TABLET, EXTENDED RELEASE · ORAL 25MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	5
MIRABEGRON MYRBETRIQ	202611 Product 202611/002	TABLET, EXTENDED RELEASE · ORAL 50MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	5
MIRABEGRON MYRBETRIQ GRANULES	213801 Product 213801/001	FOR SUSPENSION, EXTENDED RELEASE · ORAL 8MG/ML FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	1
MIRDAMETINIB GOMEKLI	219379 Product 219379/001	TABLET, FOR SUSPENSION · ORAL 1MG FDA marketing: Prescription	2041 DEEP_REVIEW FINAL	21
MIRDAMETINIB GOMEKLI	219379 Product 219379/002	TABLET, FOR SUSPENSION · ORAL 3MG FDA marketing: Prescription	2041 DEEP_REVIEW FINAL	17
MIRDAMETINIB GOMEKLI	219379 Product 219379/003	TABLET, FOR SUSPENSION · ORAL 4MG FDA marketing: Prescription	2044 DEEP_REVIEW FINAL	15
MIRDAMETINIB GOMEKLI	219389 Product 219389/001	CAPSULE · ORAL 1MG FDA marketing: Prescription	2041 DEEP_REVIEW FINAL	20
MIRDAMETINIB GOMEKLI	219389 Product 219389/002	CAPSULE · ORAL 2MG FDA marketing: Prescription	2041 DEEP_REVIEW FINAL	19
mirikizumab-mrkz Omvoh	761279 Product 761279/001	Injection · Intravenous 300MG/15ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 DEEP_REVIEW FINAL_CHECKING	3
mirikizumab-mrkz Omvoh	761279 Product 761279/002	Injection · Subcutaneous 100MG/ML Pre-Filled Syringe FDA marketing: Prescription	2035 DEEP_REVIEW FINAL_CHECKING	3
mirvetuximab soravtansine-gynx Elahere	761310 Product 761310/001	Injection · Intravenous 100MG/20ML (5MG/ML) Single-Dose Vial FDA marketing: Prescription	2034 CANDIDATE FINAL_CHECKING	5
MITAPIVAT SULFATE AQVESME	216196 Product 216196/004	TABLET · ORAL EQ 100MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	6
MITAPIVAT SULFATE PYRUKYND	216196 Product 216196/001	TABLET · ORAL EQ 5MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	9
MITAPIVAT SULFATE PYRUKYND	216196 Product 216196/002	TABLET · ORAL EQ 20MG BASE FDA marketing: Prescription	2038 DEEP_REVIEW FINAL	9
MITAPIVAT SULFATE PYRUKYND	216196 Product 216196/003	TABLET · ORAL EQ 50MG BASE FDA marketing: Prescription	2038 DEEP_REVIEW FINAL	9
MITOMYCIN JELMYTO	211728 Product 211728/001	POWDER · PYELOCALYCEAL 40MG/VIAL FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	3
MITOMYCIN MITOSOL	022572 Product 022572/001	FOR SOLUTION · TOPICAL 0.2MG/VIAL FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	5
MITOMYCIN ZUSDURI	215793 Product 215793/001	POWDER · INTRAVESICAL 40MG/VIAL FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	5
MOBOCERTINIB SUCCINATE EXKIVITY	215310 Product 215310/001	CAPSULE · ORAL EQ 40MG BASE FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	2
mogamulizumab-kpkc Poteligeo	761051 Product 761051/001	Injection · Intravenous 20MG/5ML (4MG/ML) Single-Dose Vial FDA marketing: Prescription	2030 CANDIDATE FINAL	0
MOMELOTINIB DIHYDROCHLORIDE OJJAARA	216873 Product 216873/001	TABLET · ORAL EQ 100MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	5
MOMELOTINIB DIHYDROCHLORIDE OJJAARA	216873 Product 216873/002	TABLET · ORAL EQ 150MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	5
MOMELOTINIB DIHYDROCHLORIDE OJJAARA	216873 Product 216873/003	TABLET · ORAL EQ 200MG BASE FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	5
MOMETASONE FUROATE ASMANEX HFA	205641 Product 205641/001	AEROSOL, METERED · INHALATION 0.10MG/INH FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	4
MOMETASONE FUROATE ASMANEX HFA	205641 Product 205641/002	AEROSOL, METERED · INHALATION 0.20MG/INH FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	4
MOMETASONE FUROATE ASMANEX HFA	205641 Product 205641/003	AEROSOL, METERED · INHALATION 0.05MG/INH FDA marketing: Prescription	2023 CANDIDATE FINAL	0
MOMETASONE FUROATE ELOCON	019625 Product 019625/002	CREAM · TOPICAL 0.1% FDA marketing: Discontinued	2019 DISCONTINUED FINAL	0
MOMETASONE FUROATE NASONEX 24HR ALLERGY	215712 Product 215712/001	SPRAY, METERED · NASAL 0.05MG/SPRAY FDA marketing: Over-the-counter	2022 EXCLUDED FINAL	0
MOMETASONE FUROATE SINUVA	209310 Product 209310/001	IMPLANT · IMPLANTATION 1.35MG FDA marketing: Prescription	2020 DEEP_REVIEW FINAL_CHECKING	7
MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE RYALTRIS	211746 Product 211746/001	SPRAY, METERED · NASAL 0.025MG/SPRAY;0.665MG/SPRAY FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	17
MONOMETHYL FUMARATE BAFIERTAM	210296 Product 210296/001	CAPSULE, DELAYED RELEASE · ORAL 95MG FDA marketing: Prescription	2020 DEEP_REVIEW FINAL_CHECKING	21
MORPHINE SULFATE ARYMO ER	208603 Product 208603/001	TABLET, EXTENDED RELEASE · ORAL 15MG FDA marketing: Discontinued	2018 DISCONTINUED FINAL	2
MORPHINE SULFATE ARYMO ER	208603 Product 208603/002	TABLET, EXTENDED RELEASE · ORAL 30MG FDA marketing: Discontinued	2018 DISCONTINUED FINAL	2
MORPHINE SULFATE ARYMO ER	208603 Product 208603/003	TABLET, EXTENDED RELEASE · ORAL 60MG FDA marketing: Discontinued	2018 DISCONTINUED FINAL	2
MORPHINE SULFATE KADIAN	020616 Product 020616/009	CAPSULE, EXTENDED RELEASE · ORAL 40MG FDA marketing: Discontinued	DISCONTINUED FINAL	0
MORPHINE SULFATE KADIAN	020616 Product 020616/010	CAPSULE, EXTENDED RELEASE · ORAL 70MG FDA marketing: Discontinued	DISCONTINUED FINAL	0
MORPHINE SULFATE KADIAN	020616 Product 020616/011	CAPSULE, EXTENDED RELEASE · ORAL 130MG FDA marketing: Discontinued	2023 WITHDRAWN FINAL	0
MORPHINE SULFATE KADIAN	020616 Product 020616/012	CAPSULE, EXTENDED RELEASE · ORAL 150MG FDA marketing: Discontinued	2023 WITHDRAWN FINAL	0
MORPHINE SULFATE MORPHABOND ER	206544 Product 206544/001	TABLET, EXTENDED RELEASE · ORAL 15MG FDA marketing: WITHDRAWN	2021 WITHDRAWN FINAL	2
MORPHINE SULFATE MORPHABOND ER	206544 Product 206544/002	TABLET, EXTENDED RELEASE · ORAL 30MG FDA marketing: WITHDRAWN	2021 WITHDRAWN FINAL	2
MORPHINE SULFATE MORPHABOND ER	206544 Product 206544/003	TABLET, EXTENDED RELEASE · ORAL 60MG FDA marketing: WITHDRAWN	2021 WITHDRAWN FINAL	2
MORPHINE SULFATE MORPHABOND ER	206544 Product 206544/004	TABLET, EXTENDED RELEASE · ORAL 100MG FDA marketing: WITHDRAWN	2021 WITHDRAWN FINAL	2
MORPHINE SULFATE MORPHINE SULFATE	022195 Product 022195/003	SOLUTION · ORAL 100MG/5ML FDA marketing: Prescription	2011 EXISTING_GENERIC DISQUALIFIED	0
MORPHINE SULFATE MORPHINE SULFATE	201517 Product 201517/001	SOLUTION · ORAL 100MG/5ML FDA marketing: Discontinued	DISCONTINUED FINAL	0
MORPHINE SULFATE MORPHINE SULFATE	202515 Product 202515/001	INJECTABLE · INJECTION 2MG/ML FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
MORPHINE SULFATE MORPHINE SULFATE	202515 Product 202515/002	INJECTABLE · INJECTION 4MG/ML FDA marketing: Prescription	2015 EXISTING_GENERIC DISQUALIFIED	0
MORPHINE SULFATE MORPHINE SULFATE	202515 Product 202515/003	INJECTABLE · INJECTION 8MG/ML FDA marketing: Prescription	2015 EXISTING_GENERIC DISQUALIFIED	0
MORPHINE SULFATE MORPHINE SULFATE	202515 Product 202515/004	INJECTABLE · INJECTION 10MG/ML FDA marketing: Prescription	2015 EXISTING_GENERIC DISQUALIFIED	0
MORPHINE SULFATE MORPHINE SULFATE	202515 Product 202515/005	INJECTABLE · INJECTION 15MG/ML FDA marketing: Discontinued	2015 DISCONTINUED FINAL	0
MORPHINE SULFATE MORPHINE SULFATE	202515 Product 202515/006	INJECTABLE · INJECTION 50MG/ML FDA marketing: Prescription	2021 DEEP_REVIEW FINAL	0
MORPHINE SULFATE MORPHINE SULFATE	204223 Product 204223/001	SOLUTION · INTRAMUSCULAR, INTRAVENOUS 2MG/ML (2MG/ML) FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	3
MORPHINE SULFATE MORPHINE SULFATE	204223 Product 204223/002	SOLUTION · INTRAMUSCULAR, INTRAVENOUS 4MG/ML (4MG/ML) FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	3
MORPHINE SULFATE MORPHINE SULFATE	204223 Product 204223/003	SOLUTION · INTRAMUSCULAR, INTRAVENOUS 5MG/ML (5MG/ML) FDA marketing: Discontinued	2024 DISCONTINUED FINAL	3
MORPHINE SULFATE MORPHINE SULFATE	204223 Product 204223/004	SOLUTION · INTRAMUSCULAR, INTRAVENOUS 8MG/ML (8MG/ML) FDA marketing: Discontinued	2024 DISCONTINUED FINAL	3
MORPHINE SULFATE MORPHINE SULFATE	204223 Product 204223/005	SOLUTION · INTRAMUSCULAR, INTRAVENOUS 10MG/ML (10MG/ML) FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	3
MORPHINE SULFATE MORPHINE SULFATE	204223 Product 204223/006	SOLUTION · INTRAMUSCULAR, INTRAVENOUS 1MG/0.5ML (1MG/0.5ML) FDA marketing: Discontinued	Master only	0
MORPHINE SULFATE MORPHINE SULFATE	204223 Product 204223/006	SOLUTION · INTRAMUSCULAR, INTRAVENOUS 1MG/0.5ML (1MG/0.5ML) FDA marketing: Discontinued	Master only	0
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE EMBEDA	022321 Product 022321/001	CAPSULE, EXTENDED RELEASE · ORAL 20MG;0.8MG FDA marketing: DISCONTINUED	2012 DEEP_REVIEW FINAL	9
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE EMBEDA	022321 Product 022321/002	CAPSULE, EXTENDED RELEASE · ORAL 30MG;1.2MG FDA marketing: DISCONTINUED	2012 DEEP_REVIEW FINAL	9
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE EMBEDA	022321 Product 022321/003	CAPSULE, EXTENDED RELEASE · ORAL 50MG;2MG FDA marketing: DISCONTINUED	2012 DEEP_REVIEW FINAL	9
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE EMBEDA	022321 Product 022321/004	CAPSULE, EXTENDED RELEASE · ORAL 60MG;2.4MG FDA marketing: DISCONTINUED	2012 DEEP_REVIEW FINAL	9
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE EMBEDA	022321 Product 022321/005	CAPSULE, EXTENDED RELEASE · ORAL 80MG;3.2MG FDA marketing: DISCONTINUED	2012 DEEP_REVIEW FINAL	9
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE EMBEDA	022321 Product 022321/006	CAPSULE, EXTENDED RELEASE · ORAL 100MG;4MG FDA marketing: DISCONTINUED	2012 DEEP_REVIEW FINAL	9
mosunetuzumab-axgb Lunsumio	761263 Product 761263/001	Injection · Intravenous 1MG/ML Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	2
mosunetuzumab-axgb Lunsumio	761263 Product 761263/002	Injection · Intravenous 30MG/30ML (1MG/ML) Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	2
mosunetuzumab-axgb Lunsumio Velo	761263 Product 761263/003	Injection · Subcutaneous 5MG/0.5ML Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	2
mosunetuzumab-axgb Lunsumio Velo	761263 Product 761263/004	Injection · Subcutaneous 45MG/ML Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	2
MOTIXAFORTIDE ACETATE APHEXDA	217159 Product 217159/001	POWDER · SUBCUTANEOUS EQ 62MG BASE/VIAL FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	2
moxetumomab pasudotox-tdfk Lumoxiti	761104 Product 761104/001	For Injection · Intravenous 1MG Single-Dose Vial FDA marketing: Prescription	WITHDRAWN FINAL	0
MOXIDECTIN MOXIDECTIN	210867 Product 210867/001	TABLET · ORAL 2MG FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
MOXIFLOXACIN HYDROCHLORIDE MOXEZA	022428 Product 022428/001	SOLUTION/DROPS · OPHTHALMIC EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2020 DEEP_REVIEW FINAL_CHECKING	2
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE	205572 Product 205572/001	SOLUTION · INTRAVENOUS EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML) FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	0
MUPIROCIN CALCIUM MUPIROCIN CALCIUM	218361 Product 218361/001	CREAM · TOPICAL EQ 2% BASE FDA marketing: Prescription	Master only	0
MYCOPHENOLATE MOFETIL MYHIBBIN	216482 Product 216482/001	SUSPENSION · ORAL 200MG/ML FDA marketing: Prescription	2024 DEEP_REVIEW FINAL_CHECKING	5
NAFCILLIN SODIUM NAFCILLIN SODIUM	203830 Product 203830/001	INJECTABLE · INJECTION EQ 10GM BASE/VIAL FDA marketing: Prescription	Master only	0
NAFTIFINE HYDROCHLORIDE NAFTIN	019599 Product 019599/002	CREAM · TOPICAL 2% FDA marketing: Prescription	2016 EXISTING_GENERIC DISQUALIFIED	0
NAFTIFINE HYDROCHLORIDE NAFTIN	204286 Product 204286/001	GEL · TOPICAL 2% FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	6
NALDEMEDINE TOSYLATE SYMPROIC	208854 Product 208854/001	TABLET · ORAL EQ 0.2MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	5
NALMEFENE HYDROCHLORIDE OPVEE	217470 Product 217470/001	SPRAY · NASAL EQ 2.7MG BASE/SPRAY FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	2
NALMEFENE HYDROCHLORIDE ZURNAI (AUTOINJECTOR)	218590 Product 218590/001	SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML) FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	2
NALOXEGOL OXALATE MOVANTIK	204760 Product 204760/001	TABLET · ORAL EQ 12.5MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	2
NALOXEGOL OXALATE MOVANTIK	204760 Product 204760/002	TABLET · ORAL EQ 25MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	2
NALOXONE HYDROCHLORIDE EVZIO	205787 Product 205787/001	SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS 0.4MG/0.4ML (0.4MG/0.4ML) FDA marketing: Discontinued	2017 DISCONTINUED FINAL	21
NALOXONE HYDROCHLORIDE EVZIO (AUTOINJECTOR)	209862 Product 209862/001	SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS 2MG/0.4ML (2MG/0.4ML) FDA marketing: Discontinued	2020 DISCONTINUED FINAL	21
NALOXONE HYDROCHLORIDE KLOXXADO	212045 Product 212045/001	SPRAY · NASAL 8MG/SPRAY FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	7
NALOXONE HYDROCHLORIDE KLOXXADO	212045 Product 212045/002	SPRAY · NASAL 4MG/SPRAY FDA marketing: Discontinued	2025 DEEP_REVIEW FINAL	6
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	215457 Product 215457/001	SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS 10MG/0.4ML (10MG/0.4ML) FDA marketing: Discontinued	2022 DISCONTINUED FINAL	6
NALOXONE HYDROCHLORIDE NARCAN	208411 Product 208411/001	SPRAY, METERED · NASAL 4MG/SPRAY FDA marketing: Over-the-counter	2015 EXCLUDED FINAL	0
NALOXONE HYDROCHLORIDE NARCAN	208411 Product 208411/002	SPRAY, METERED · NASAL 2MG/SPRAY FDA marketing: Discontinued	2023 WITHDRAWN FINAL	2
NALOXONE HYDROCHLORIDE REXTOVY	208969 Product 208969/001	SPRAY, METERED · NASAL 4MG/SPRAY FDA marketing: Over-the-counter	2023 EXCLUDED FINAL	0
NALOXONE HYDROCHLORIDE REZENOPY	215487 Product 215487/001	SPRAY · NASAL 10MG/SPRAY FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	2
NALOXONE HYDROCHLORIDE RIVIVE	217722 Product 217722/001	SPRAY, METERED · NASAL 3MG/SPRAY FDA marketing: Over-the-counter	2023 EXCLUDED FINAL	3
NALOXONE HYDROCHLORIDE ZIMHI	212854 Product 212854/001	SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS 5MG/0.5ML (5MG/0.5ML) FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	2
NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TARGINIQ	205777 Product 205777/001	TABLET, EXTENDED RELEASE · ORAL 5MG;10MG FDA marketing: Discontinued	2018 WITHDRAWN FINAL	24
NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TARGINIQ	205777 Product 205777/002	TABLET, EXTENDED RELEASE · ORAL 10MG;20MG FDA marketing: Discontinued	2018 WITHDRAWN FINAL	24
NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TARGINIQ	205777 Product 205777/003	TABLET, EXTENDED RELEASE · ORAL 20MG;40MG FDA marketing: Discontinued	2018 WITHDRAWN FINAL	22
NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TROXYCA ER	207621 Product 207621/001	CAPSULE, EXTENDED RELEASE · ORAL 1.2MG;10MG FDA marketing: Discontinued	2018 WITHDRAWN FINAL	1
NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TROXYCA ER	207621 Product 207621/002	CAPSULE, EXTENDED RELEASE · ORAL 2.4MG;20MG FDA marketing: Discontinued	2018 WITHDRAWN FINAL	1
NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TROXYCA ER	207621 Product 207621/003	CAPSULE, EXTENDED RELEASE · ORAL 3.6MG;30MG FDA marketing: Discontinued	2018 WITHDRAWN FINAL	1
NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TROXYCA ER	207621 Product 207621/004	CAPSULE, EXTENDED RELEASE · ORAL 4.8MG;40MG FDA marketing: Discontinued	2018 WITHDRAWN FINAL	1
NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TROXYCA ER	207621 Product 207621/005	CAPSULE, EXTENDED RELEASE · ORAL 7.2MG;60MG FDA marketing: Discontinued	2018 WITHDRAWN FINAL	1
NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TROXYCA ER	207621 Product 207621/006	CAPSULE, EXTENDED RELEASE · ORAL 9.6MG;80MG FDA marketing: Discontinued	2018 WITHDRAWN FINAL	1
NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE TREXIMET	021926 Product 021926/002	TABLET · ORAL 60MG;EQ 10MG BASE FDA marketing: Discontinued	2018 DISCONTINUED FINAL	1
narsoplimab-wuug Yartemlea	761152 Product 761152/001	Injection · Intravenous 370MG/2ML Single-Dose Vial FDA marketing: Prescription	2037 CANDIDATE FINAL_CHECKING	3
natalizumab Tysabri	125104 Product 125104/001	Injection · Intravenous 300MG/15ML (20MG/ML) Single-Dose Vial FDA marketing: Rx	2017 DEEP_REVIEW FINAL	32
natalizumab-sztn Tyruko	761322 Product 761322/001	Injection · Intravenous 300MG/15ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
NAVEPEGRITIDE YUVIWEL	219164 Product 219164/001	POWDER · SUBCUTANEOUS 1.3MG/VIAL FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	12
NAVEPEGRITIDE YUVIWEL	219164 Product 219164/002	POWDER · SUBCUTANEOUS 2.8MG/VIAL FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	12
NAVEPEGRITIDE YUVIWEL	219164 Product 219164/003	POWDER · SUBCUTANEOUS 5.5MG/VIAL FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	12
naxitamab-gqgk Danyelza	761171 Product 761171/001	Injection · Intravenous 40MG/10ML (4MG/ML) Single-Dose Vial FDA marketing: Prescription	2034 CANDIDATE FINAL	0
NEBIVOLOL HYDROCHLORIDE; VALSARTAN BYVALSON	206302 Product 206302/001	TABLET · ORAL EQ 5MG BASE;80MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	2
necitumumab Portrazza	125547 Product 125547/001	Injection · Intravenous 800MG/50ML (16MG/ML) Single-Dose Vial FDA marketing: Prescription	2028 CANDIDATE FINAL	0
NEDOSIRAN SODIUM RIVFLOZA	215842 Product 215842/001	SOLUTION · INJECTION EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) FDA marketing: Prescription	2038 CANDIDATE FINAL	6
NEDOSIRAN SODIUM RIVFLOZA	215842 Product 215842/002	SOLUTION · INJECTION EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML) FDA marketing: Prescription	2038 CANDIDATE FINAL	6
NEDOSIRAN SODIUM RIVFLOZA	215842 Product 215842/003	SOLUTION · INJECTION EQ 160MG BASE/ML (EQ 160MG BASE/ML) FDA marketing: Prescription	2038 CANDIDATE FINAL	6
nemolizumab-ilto Nemluvio	761390 Product 761390/001	For Injection · Subcutaneous 30MG Autoinjector FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	1
NEOSTIGMINE METHYLSULFATE BLOXIVERZ	204078 Product 204078/001	SOLUTION · INTRAVENOUS 5MG/10ML (0.5MG/ML) FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	0
NEOSTIGMINE METHYLSULFATE BLOXIVERZ	204078 Product 204078/002	SOLUTION · INTRAVENOUS 10MG/10ML (1MG/ML) FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	0
NEOSTIGMINE METHYLSULFATE BLOXIVERZ	204078 Product 204078/003	SOLUTION · INTRAVENOUS 5MG/5ML (1MG/ML) FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	0
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE	203629 Product 203629/001	SOLUTION · INTRAVENOUS 5MG/10ML (0.5MG/ML) FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	0
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE	203629 Product 203629/002	SOLUTION · INTRAVENOUS 10MG/10ML (1MG/ML) FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	0
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE	203629 Product 203629/003	SOLUTION · INTRAVENOUS 3MG/3ML (1MG/ML) FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
NEPAFENAC ILEVRO	203491 Product 203491/001	SUSPENSION/DROPS · OPHTHALMIC 0.3% FDA marketing: Prescription	2015 DEEP_REVIEW FINAL_CHECKING	2
NEPAFENAC NEVANAC	021862 Product 021862/001	SUSPENSION/DROPS · OPHTHALMIC 0.1% 3 mL in a 4 mL dropper bottle FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	4
NERANDOMILAST JASCAYD	218764 Product 218764/001	TABLET · ORAL 9MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	5
NERANDOMILAST JASCAYD	218764 Product 218764/002	TABLET · ORAL 18MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	5
NERATINIB MALEATE NERLYNX	208051 Product 208051/001	TABLET · ORAL EQ 40MG BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	9
NETARSUDIL MESYLATE RHOPRESSA	208254 Product 208254/001	SOLUTION/DROPS · OPHTHALMIC EQ 0.02% BASE FDA marketing: Prescription	2034 CANDIDATE FINAL	15
NETUPITANT; PALONOSETRON HYDROCHLORIDE AKYNZEO	205718 Product 205718/001	CAPSULE · ORAL 300MG;EQ 0.5MG BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	12
NEVIRAPINE VIRAMUNE XR	201152 Product 201152/001	TABLET, EXTENDED RELEASE · ORAL 400MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	1
NEVIRAPINE VIRAMUNE XR	201152 Product 201152/002	TABLET, EXTENDED RELEASE · ORAL 100MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	0
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	022276 Product 022276/002	INJECTABLE · INTRAVENOUS 20MG/200ML (0.1MG/ML) FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	022276 Product 022276/003	INJECTABLE · INTRAVENOUS 40MG/200ML (0.2MG/ML) FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
NIFURTIMOX LAMPIT	213464 Product 213464/001	TABLET · ORAL 30MG FDA marketing: Prescription	2027 CANDIDATE FINAL	0
NIFURTIMOX LAMPIT	213464 Product 213464/002	TABLET · ORAL 120MG FDA marketing: Prescription	2027 CANDIDATE FINAL	0
NILOTINIB CAVHANZA	217379 Product 217379/001	TABLET, ORALLY DISINTEGRATING · ORAL 60MG FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	4
NILOTINIB CAVHANZA	217379 Product 217379/002	TABLET, ORALLY DISINTEGRATING · ORAL 80MG FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	4
NILOTINIB D-TARTRATE NILOTINIB D-TARTRATE	218922 Product 218922/001	CAPSULE · ORAL EQ 50MG BASE FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	1
NILOTINIB D-TARTRATE NILOTINIB D-TARTRATE	218922 Product 218922/002	CAPSULE · ORAL EQ 150MG BASE FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	1
NILOTINIB D-TARTRATE NILOTINIB D-TARTRATE	218922 Product 218922/003	CAPSULE · ORAL EQ 200MG BASE FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	1
NILOTINIB HYDROCHLORIDE TASIGNA	022068 Product 022068/002	CAPSULE · ORAL EQ 150MG BASE FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	6
NILOTINIB HYDROCHLORIDE TASIGNA	022068 Product 022068/003	CAPSULE · ORAL EQ 50MG BASE FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	6
NILOTINIB TARTRATE DANZITEN	219293 Product 219293/001	TABLET · ORAL EQ 71MG BASE FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	4
NILOTINIB TARTRATE DANZITEN	219293 Product 219293/002	TABLET · ORAL EQ 95MG BASE FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	4
NIMODIPINE NYMALIZE	203340 Product 203340/001	SOLUTION · ORAL 3MG/ML FDA marketing: Discontinued	2020 DISCONTINUED FINAL	0
NIMODIPINE NYMALIZE	203340 Product 203340/002	SOLUTION · ORAL 6MG/ML FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	6
NINTEDANIB ESYLATE OFEV	205832 Product 205832/001	CAPSULE · ORAL EQ 100MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	4
NINTEDANIB ESYLATE OFEV	205832 Product 205832/002	CAPSULE · ORAL EQ 150MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	4
nipocalimab-aahu Imaavy	761430 Product 761430/001	Injection · Intravenous 300MG/1.62ML (185MG/ML) Single-Dose Vial FDA marketing: Prescription	2037 CANDIDATE FINAL_CHECKING	1
nipocalimab-aahu Imaavy	761430 Product 761430/002	Injection · Intravenous 1,200MG/6.5ML (185MG/ML) Single-Dose Vial FDA marketing: Prescription	2037 CANDIDATE FINAL_CHECKING	1
NIRAPARIB TOSYLATE ZEJULA	208447 Product 208447/001	CAPSULE · ORAL EQ 100MG BASE FDA marketing: DISCONTINUED	2024 DISQUALIFIED FINAL	7
NIRAPARIB TOSYLATE ZEJULA	214876 Product 214876/001	TABLET · ORAL EQ 100MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	8
NIRAPARIB TOSYLATE ZEJULA	214876 Product 214876/002	TABLET · ORAL EQ 200MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	8
NIRAPARIB TOSYLATE ZEJULA	214876 Product 214876/003	TABLET · ORAL EQ 300MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	8
NIRMATRELVIR; RITONAVIR PAXLOVID (COPACKAGED)	217188 Product 217188/001	TABLET · ORAL 150MG;100MG FDA marketing: Prescription	2041 CANDIDATE FINAL	2
NIROGACESTAT HYDROBROMIDE OGSIVEO	217677 Product 217677/001	TABLET · ORAL EQ 50MG BASE FDA marketing: DISCONTINUED	2026 DISQUALIFIED FINAL	29
NIROGACESTAT HYDROBROMIDE OGSIVEO	217677 Product 217677/002	TABLET · ORAL EQ 100MG BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	29
NIROGACESTAT HYDROBROMIDE OGSIVEO	217677 Product 217677/003	TABLET · ORAL EQ 150MG BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	29
nirsevimab-alip Beyfortus	761328 Product 761328/001	Injection · Intramuscular 50MG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	1
nirsevimab-alip Beyfortus	761328 Product 761328/002	Injection · Intramuscular 100MG/ML Pre-Filled Syringe FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	1
NITISINONE HARLIKU	209449 Product 209449/004	TABLET · ORAL 2MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	1
NITISINONE NITYR	209449 Product 209449/001	TABLET · ORAL 2MG FDA marketing: Prescription	2017 DEEP_REVIEW FINAL_CHECKING	1
NITISINONE NITYR	209449 Product 209449/002	TABLET · ORAL 5MG FDA marketing: Prescription	2017 DEEP_REVIEW FINAL_CHECKING	1
NITISINONE NITYR	209449 Product 209449/003	TABLET · ORAL 10MG FDA marketing: Prescription	2017 DEEP_REVIEW FINAL_CHECKING	1
NITISINONE ORFADIN	021232 Product 021232/004	CAPSULE · ORAL 20MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
NITISINONE ORFADIN	206356 Product 206356/001	SUSPENSION · ORAL 4MG/ML FDA marketing: Prescription	2016 DEEP_REVIEW FINAL_CHECKING	1
NITRIC OXIDE GENOSYL	202860 Product 202860/001	GAS · INHALATION 800PPM FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	14
NITRIC OXIDE INOMAX	020845 Product 020845/004	GAS · INHALATION 4880PPM FDA marketing: Prescription	Master only	1
NITROFURANTOIN FURADANTIN	009175 Product 009175/002	SUSPENSION · ORAL 50MG/5ML FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
NITROGEN NITROGEN, NF	205738 Product 205738/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROGEN NITROGEN, NF	205766 Product 205766/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROGEN NITROGEN, NF	205805 Product 205805/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROGEN NITROGEN, NF	205816 Product 205816/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROGEN NITROGEN, NF	205829 Product 205829/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROGEN NITROGEN, NF	205839 Product 205839/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROGEN NITROGEN, NF	205850 Product 205850/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROGEN NITROGEN, NF	205863 Product 205863/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROGEN NITROGEN, NF	205866 Product 205866/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROGEN NITROGEN, NF	205891 Product 205891/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROGEN NITROGEN, NF	205985 Product 205985/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROGEN NITROGEN, NF	206024 Product 206024/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROGEN NITROGEN, NF	211737 Product 211737/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
Nitrogen Nitrogen, NF	214858 Product 214858/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
Nitrogen Nitrogen, NF	217499 Product 217499/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROGEN, NF NITROGEN, NF	212315 Product 212315/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROGLYCERIN GONITRO	208424 Product 208424/001	POWDER · SUBLINGUAL 0.4MG/PACKET FDA marketing: Discontinued	2021 DISCONTINUED FINAL	1
NITROGLYCERIN RECTIV	021359 Product 021359/001	OINTMENT · INTRA-ANAL 0.4% FDA marketing: Discontinued	2026 DISCONTINUED FINAL	1
NITROUS OXIDE NITROUS OXIDE, USP	205704 Product 205704/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROUS OXIDE NITROUS OXIDE, USP	206009 Product 206009/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROUS OXIDE NITROUS OXIDE, USP	206014 Product 206014/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROUS OXIDE NITROUS OXIDE, USP	208069 Product 208069/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROUS OXIDE NITROUS OXIDE, USP	209989 Product 209989/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
NITROUS OXIDE NITROUS OXIDE, USP	210235 Product 210235/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
nivolumab Opdivo	125554 Product 125554/001	Injection · Intravenous 40MG/4ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	0
nivolumab Opdivo	125554 Product 125554/002	Injection · Intravenous 100MG/10ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	0
nivolumab and hyaluronidase-nvhy Opdivo Qvantig	761381 Product 761381/001	Injection · Subcutaneous 600MG/5ML;10,000UNITS/5ML (120MG/2,000UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	1
nivolumab and relatlimab-rmbw Opdualag	761234 Product 761234/001	Injection · Intravenous 240MG, 80MG/20ML (12MG, 4MG/ML) Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	2
nogapendekin alfa inbakicept-pmln Anktiva	761336 Product 761336/001	Solution · Intravesical 400MCG/0.4ML Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	1
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	214313 Product 214313/004	SOLUTION · INTRAVENOUS EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	214313 Product 214313/005	SOLUTION · INTRAVENOUS EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	214313 Product 214313/006	SOLUTION · INTRAVENOUS EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	214628 Product 214628/001	SOLUTION · INTRAVENOUS EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	7
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	214628 Product 214628/002	SOLUTION · INTRAVENOUS EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	7
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	214628 Product 214628/003	SOLUTION · INTRAVENOUS EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	7
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	215700 Product 215700/001	SOLUTION · INTRAVENOUS EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	2
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	215700 Product 215700/002	SOLUTION · INTRAVENOUS EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	2
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	215700 Product 215700/003	SOLUTION · INTRAVENOUS EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	3
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	215700 Product 215700/004	SOLUTION · INTRAVENOUS EQ 32MG BASE/250ML (EQ 128MCG BASE/ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	3
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	214313 Product 214313/001	SOLUTION · INTRAVENOUS EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	3
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	214313 Product 214313/002	SOLUTION · INTRAVENOUS EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	3
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	214313 Product 214313/003	SOLUTION · INTRAVENOUS EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	1
NUSINERSEN SODIUM SPINRAZA	209531 Product 209531/001	SOLUTION · INTRATHECAL EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML) FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	7
NUSINERSEN SODIUM SPINRAZA	209531 Product 209531/002	SOLUTION · INTRATHECAL EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML) FDA marketing: Prescription	2030 CANDIDATE FINAL	4
NUSINERSEN SODIUM SPINRAZA	209531 Product 209531/003	SOLUTION · INTRATHECAL EQ 50MG BASE/5ML (EQ 10MG BASE/ML) FDA marketing: Prescription	2030 CANDIDATE FINAL	4
OBETICHOLIC ACID OCALIVA	207999 Product 207999/001	TABLET · ORAL 5MG FDA marketing: WITHDRAWN	2025 WITHDRAWN FINAL	7
OBETICHOLIC ACID OCALIVA	207999 Product 207999/002	TABLET · ORAL 10MG FDA marketing: WITHDRAWN	2025 WITHDRAWN FINAL	7
obiltoxaximab Anthim	125509 Product 125509/001	Injection · Intravenous 600MG/6ML (100MG/ML) Single-Dose Vial FDA marketing: Prescription	2028 CANDIDATE FINAL	0
obinutuzumab Gazyva	125486 Product 125486/001	Injection · Intravenous 1,000MG/40ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
ocrelizumab Ocrevus	761053 Product 761053/001	Injection · Intravenous 300MG/10ML (30MG/ML) Single-Dose Vial FDA marketing: Prescription	2029 CANDIDATE FINAL	0
ocrelizumab and hyaluronidase-ocsq Ocrevus Zunovo	761371 Product 761371/001	Injection · Subcutaneous 920MG/23ML; 23,000UNITS/23ML (40MG/1,000UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2029 DEEP_REVIEW FINAL_CHECKING	0
ocriplasmin Jetrea	125422 Product 125422/002	Injection · Intravitreal 0.5MG/0.2ML (2.5MG/ML) Single-Dose Vial FDA marketing: Prescription	WITHDRAWN FINAL	0
OCTREOTIDE ACETATE BYNFEZIA PEN	213224 Product 213224/001	SOLUTION · SUBCUTANEOUS EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL_CHECKING	5
OCTREOTIDE ACETATE MYCAPSSA	208232 Product 208232/001	CAPSULE, DELAYED RELEASE · ORAL EQ 20MG BASE FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	16
ODEVIXIBAT BYLVAY	215498 Product 215498/001	CAPSULE, PELLETS · ORAL 0.2MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	16
ODEVIXIBAT BYLVAY	215498 Product 215498/002	CAPSULE · ORAL 0.4MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	16
ODEVIXIBAT BYLVAY	215498 Product 215498/003	CAPSULE, PELLETS · ORAL 0.6MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	16
ODEVIXIBAT BYLVAY	215498 Product 215498/004	CAPSULE · ORAL 1.2MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	16
OLANZAPINE WELTRUZA	219007 Product 219007/001	SUSPENSION, EXTENDED RELEASE · INJECTABLE 318MG FDA marketing: Prescription	Master only	0
OLANZAPINE WELTRUZA	219007 Product 219007/002	SUSPENSION, EXTENDED RELEASE · INJECTABLE 425MG FDA marketing: Prescription	Master only	0
OLANZAPINE WELTRUZA	219007 Product 219007/003	SUSPENSION, EXTENDED RELEASE · INJECTABLE 531MG FDA marketing: Prescription	Master only	0
OLANZAPINE; SAMIDORPHAN L-MALATE LYBALVI	213378 Product 213378/001	TABLET · ORAL 5MG;EQ 10MG BASE FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	14
OLANZAPINE; SAMIDORPHAN L-MALATE LYBALVI	213378 Product 213378/002	TABLET · ORAL 10MG;EQ 10MG BASE FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	14
OLANZAPINE; SAMIDORPHAN L-MALATE LYBALVI	213378 Product 213378/003	TABLET · ORAL 15MG;EQ 10MG BASE FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	14
OLANZAPINE; SAMIDORPHAN L-MALATE LYBALVI	213378 Product 213378/004	TABLET · ORAL 20MG;EQ 10MG BASE FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	14
OLAPARIB LYNPARZA	206162 Product 206162/001	CAPSULE · ORAL 50MG FDA marketing: DISCONTINUED	2020 DISQUALIFIED FINAL	3
OLAPARIB LYNPARZA	208558 Product 208558/001	TABLET · ORAL 100MG FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	11
OLAPARIB LYNPARZA	208558 Product 208558/002	TABLET · ORAL 150MG FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	11
olaratumab Lartruvo	761038 Product 761038/001	Injection · Intravenous 500MG/50ML (10MG/ML) Single-Dose Vial FDA marketing: Discontinued	2020 WITHDRAWN FINAL	0
OLEZARSEN SODIUM TRYNGOLZA (AUTOINJECTOR)	218614 Product 218614/001	SOLUTION · SUBCUTANEOUS EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) FDA marketing: Prescription	2034 CANDIDATE FINAL	6
OLEZARSEN SODIUM TRYNGOLZA (AUTOINJECTOR)	218614 Product 218614/002	SOLUTION · SUBCUTANEOUS EQ 50MG BASE/0.8ML (EQ 50MG BASE/0.8ML) FDA marketing: Prescription	2034 CANDIDATE FINAL	5
OLICERIDINE OLINVYK	210730 Product 210730/001	SOLUTION · INTRAVENOUS 1MG/ML (1MG/ML) FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	5
OLICERIDINE OLINVYK	210730 Product 210730/002	SOLUTION · INTRAVENOUS 2MG/2ML (1MG/ML) FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	5
OLICERIDINE OLINVYK	210730 Product 210730/003	SOLUTION · INTRAVENOUS 30MG/30ML (1MG/ML) FDA marketing: DISCONTINUED	2024 DISQUALIFIED FINAL	5
olipudase alfa-rpcp Xenpozyme	761261 Product 761261/001	For Injection · Intravenous 20MG Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	2
OLIVE OIL; SOYBEAN OIL CLINOLIPID 20%	204508 Product 204508/001	EMULSION · INTRAVENOUS 16%(160GM/1000ML);4% (40GM/1000ML) FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
OLODATEROL HYDROCHLORIDE STRIVERDI RESPIMAT	203108 Product 203108/001	SPRAY, METERED · INHALATION EQ 0.0025MG BASE/INH FDA marketing: Prescription	2027 CANDIDATE FINAL	1
OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE STIOLTO RESPIMAT	206756 Product 206756/001	SPRAY, METERED · INHALATION EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	5
OLOPATADINE HYDROCHLORIDE PATADAY ONCE DAILY RELIEF	206276 Product 206276/001	SOLUTION/DROPS · OPHTHALMIC EQ 0.7% BASE FDA marketing: Over-the-counter	2015 EXCLUDED FINAL	2
OLUTASIDENIB REZLIDHIA	215814 Product 215814/001	CAPSULE · ORAL 150MG FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	14
OMACETAXINE MEPESUCCINATE SYNRIBO	203585 Product 203585/001	POWDER · SUBCUTANEOUS 3.5MG/VIAL FDA marketing: Discontinued	2024 DISCONTINUED FINAL	1
OMADACYCLINE TOSYLATE NUZYRA	209816 Product 209816/001	TABLET · ORAL EQ 150MG BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	8
OMADACYCLINE TOSYLATE NUZYRA	209817 Product 209817/001	POWDER · INTRAVENOUS EQ 100MG BASE/VIAL FDA marketing: Prescription	2030 DEEP_REVIEW FINAL_CHECKING	5
omalizumab Xolair	103976 Product 103976/001	For Injection · Subcutaneous 150MG Single-Dose Vial FDA marketing: Rx	2015 DEEP_REVIEW FINAL	8
omalizumab Xolair	103976 Product 103976/002	Injection · Subcutaneous 75MG/0.5ML Pre-Filled Syringe FDA marketing: Rx	2015 DEEP_REVIEW FINAL	8
omalizumab Xolair	103976 Product 103976/003	Injection · Subcutaneous 150MG/ML Pre-Filled Syringe FDA marketing: Rx	2015 DEEP_REVIEW FINAL	8
omalizumab Xolair	103976 Product 103976/004	Injection · Subcutaneous 300MG/2ML Pre-Filled Syringe FDA marketing: Rx	2025 EXISTING_GENERIC FINAL	17
omalizumab Xolair	103976 Product 103976/005	Injection · Subcutaneous 75MG/0.5ML Autoinjector FDA marketing: Rx	2015 DEEP_REVIEW FINAL_CHECKING	17
omalizumab Xolair	103976 Product 103976/006	Injection · Subcutaneous 150MG/ML Autoinjector FDA marketing: Rx	2015 DEEP_REVIEW FINAL_CHECKING	17
omalizumab Xolair	103976 Product 103976/007	Injection · Subcutaneous 300MG/2ML Autoinjector FDA marketing: Rx	2015 DEEP_REVIEW FINAL_CHECKING	17
omalizumab-igec Omlyclo	761399 Product 761399/001	Injection · Subcutaneous 75MG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
omalizumab-igec Omlyclo	761399 Product 761399/002	Injection · Subcutaneous 150MG/ML Pre-Filled Syringe FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
omalizumab-igec Omlyclo	761399 Product 761399/003	Injection · Subcutaneous 300MG/2ML (150MG/ML) Pre-Filled Syringe FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
OMAVELOXOLONE SKYCLARYS	216718 Product 216718/001	CAPSULE · ORAL 50MG FDA marketing: Prescription	2037 CANDIDATE FINAL	7
OMBITASVIR; PARITAPREVIR; RITONAVIR TECHNIVIE	207931 Product 207931/001	TABLET · ORAL 12.5MG;75MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2019 DISQUALIFIED FINAL	6
OMEGA-3-ACID ETHYL ESTERS TYPE A OMTRYG	204977 Product 204977/001	CAPSULE · ORAL 1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS FDA marketing: Discontinued	2017 DISCONTINUED FINAL	0
OMEGA-3-CARBOXYLIC ACIDS EPANOVA	205060 Product 205060/001	CAPSULE · ORAL 1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS FDA marketing: Discontinued	Master only	4
OMEPRAZOLE OMEPRAZOLE	209400 Product 209400/001	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE · ORAL 20MG FDA marketing: Over-the-counter	2017 EXCLUDED FINAL	2
OMEPRAZOLE; SODIUM BICARBONATE KONVOMEP	213593 Product 213593/001	FOR SUSPENSION · ORAL 2MG/ML;84MG/ML FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	8
OMEPRAZOLE; SODIUM BICARBONATE ZEGERID OTC	022283 Product 022283/001	FOR SUSPENSION · ORAL 20MG/PACKET;1.68GM/PACKET FDA marketing: Over-the-counter	2013 EXCLUDED FINAL	0
OMIDENEPAG ISOPROPYL OMLONTI	215092 Product 215092/001	SOLUTION · OPHTHALMIC 0.002% FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	13
ONDANSETRON ZUPLENZ	022524 Product 022524/001	FILM · ORAL 4MG FDA marketing: Discontinued	2010 DEEP_REVIEW FINAL_CHECKING	2
ONDANSETRON ZUPLENZ	022524 Product 022524/002	FILM · ORAL 8MG FDA marketing: Discontinued	2010 DEEP_REVIEW FINAL_CHECKING	2
OPICAPONE ONGENTYS	212489 Product 212489/001	CAPSULE · ORAL 25MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	9
OPICAPONE ONGENTYS	212489 Product 212489/002	CAPSULE · ORAL 50MG FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	9
ORFORGLIPRON CALCIUM FOUNDAYO	220934 Product 220934/001	TABLET · ORAL EQ 0.8MG BASE FDA marketing: Prescription	2037 CANDIDATE FINAL	1
ORFORGLIPRON CALCIUM FOUNDAYO	220934 Product 220934/002	TABLET · ORAL EQ 2.5MG BASE FDA marketing: Prescription	2037 CANDIDATE FINAL	1
ORFORGLIPRON CALCIUM FOUNDAYO	220934 Product 220934/003	TABLET · ORAL EQ 5.5MG BASE FDA marketing: Prescription	2037 CANDIDATE FINAL	1
ORFORGLIPRON CALCIUM FOUNDAYO	220934 Product 220934/004	TABLET · ORAL EQ 9MG BASE FDA marketing: Prescription	2037 CANDIDATE FINAL	1
ORFORGLIPRON CALCIUM FOUNDAYO	220934 Product 220934/005	TABLET · ORAL EQ 14.5MG BASE FDA marketing: Prescription	2037 CANDIDATE FINAL	1
ORFORGLIPRON CALCIUM FOUNDAYO	220934 Product 220934/006	TABLET · ORAL EQ 17.2MG BASE FDA marketing: Prescription	2037 CANDIDATE FINAL	1
ORITAVANCIN DIPHOSPHATE KIMYRSA	214155 Product 214155/001	POWDER · INTRAVENOUS EQ 1.2GM BASE/VIAL FDA marketing: Prescription	Master only	4
ORITAVANCIN DIPHOSPHATE ORBACTIV	206334 Product 206334/001	POWDER · INTRAVENOUS EQ 400MG BASE/VIAL FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	4
OSELTAMIVIR PHOSPHATE TAMIFLU	021246 Product 021246/002	FOR SUSPENSION · ORAL EQ 6MG BASE/ML FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
OSILODROSTAT PHOSPHATE ISTURISA	212801 Product 212801/001	TABLET · ORAL EQ 1MG BASE FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	6
OSILODROSTAT PHOSPHATE ISTURISA	212801 Product 212801/002	TABLET · ORAL EQ 5MG BASE FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	6
OSILODROSTAT PHOSPHATE ISTURISA	212801 Product 212801/003	TABLET · ORAL EQ 10MG BASE FDA marketing: DISCONTINUED	2023 DISQUALIFIED FINAL	6
OSIMERTINIB MESYLATE TAGRISSO	208065 Product 208065/001	TABLET · ORAL EQ 40MG BASE FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	5
OSIMERTINIB MESYLATE TAGRISSO	208065 Product 208065/002	TABLET · ORAL EQ 80MG BASE FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	5
OSPEMIFENE OSPHENA	203505 Product 203505/001	TABLET · ORAL 60MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	2
OTESECONAZOLE VIVJOA	215888 Product 215888/001	CAPSULE · ORAL 150MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	5
OVEPOREXTON ORZEYFUL	220860 Product 220860/001	TABLET · ORAL .05MG FDA marketing: Prescription	Master only	0
OVEPOREXTON ORZEYFUL	220860 Product 220860/002	TABLET · ORAL 1MG FDA marketing: Prescription	Master only	0
OVEPOREXTON ORZEYFUL	220860 Product 220860/003	TABLET · ORAL 2MG FDA marketing: Prescription	Master only	0
OXAPROZIN COXANTO	217927 Product 217927/001	CAPSULE · ORAL 300MG FDA marketing: Prescription	2000 CANDIDATE FINAL	0
OXCARBAZEPINE OXTELLAR XR	202810 Product 202810/001	TABLET, EXTENDED RELEASE · ORAL 150MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	11
OXCARBAZEPINE OXTELLAR XR	202810 Product 202810/002	TABLET, EXTENDED RELEASE · ORAL 300MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	11
OXCARBAZEPINE OXTELLAR XR	202810 Product 202810/003	TABLET, EXTENDED RELEASE · ORAL 600MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	11
OXYBUTYNIN GELNIQUE 3%	202513 Product 202513/001	GEL, METERED · TRANSDERMAL 3% FDA marketing: Discontinued	2017 WITHDRAWN FINAL	4
OXYBUTYNIN OXYTROL FOR WOMEN	202211 Product 202211/001	FILM, EXTENDED RELEASE · TRANSDERMAL 3.9MG/24HR FDA marketing: Over-the-counter	2013 EXCLUDED FINAL	0
OXYCODONE XTAMPZA ER	208090 Product 208090/001	CAPSULE, EXTENDED RELEASE · ORAL 9MG FDA marketing: Prescription	2019 DEEP_REVIEW FINAL_CHECKING	8
OXYCODONE XTAMPZA ER	208090 Product 208090/002	CAPSULE, EXTENDED RELEASE · ORAL 13.5MG FDA marketing: Prescription	2019 DEEP_REVIEW FINAL_CHECKING	8
OXYCODONE XTAMPZA ER	208090 Product 208090/003	CAPSULE, EXTENDED RELEASE · ORAL 18MG FDA marketing: Prescription	2019 DEEP_REVIEW FINAL_CHECKING	8
OXYCODONE XTAMPZA ER	208090 Product 208090/004	CAPSULE, EXTENDED RELEASE · ORAL 27MG FDA marketing: Prescription	2019 DEEP_REVIEW FINAL_CHECKING	8
OXYCODONE XTAMPZA ER	208090 Product 208090/005	CAPSULE, EXTENDED RELEASE · ORAL 36MG FDA marketing: Prescription	2019 DEEP_REVIEW FINAL_CHECKING	8
OXYCODONE HYDROCHLORIDE OXAYDO	202080 Product 202080/001	TABLET · ORAL 5MG FDA marketing: Discontinued	DISCONTINUED FINAL	0
OXYCODONE HYDROCHLORIDE OXAYDO	202080 Product 202080/002	TABLET · ORAL 7.5MG FDA marketing: Discontinued	2023 DISCONTINUED FINAL	6
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE	200534 Product 200534/001	CAPSULE · ORAL 5MG FDA marketing: Prescription	2012 EXISTING_GENERIC DISQUALIFIED	0
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE	200535 Product 200535/001	SOLUTION · ORAL 100MG/5ML FDA marketing: Prescription	2012 EXISTING_GENERIC DISQUALIFIED	0
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE	200535 Product 200535/002	SOLUTION · ORAL 5MG/5ML FDA marketing: Prescription	2013 EXISTING_GENERIC DISQUALIFIED	0
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE	201194 Product 201194/001	SOLUTION · ORAL 5MG/5ML FDA marketing: Discontinued	2026 WITHDRAWN FINAL	0
OXYCODONE HYDROCHLORIDE OXYCONTIN	022272 Product 022272/001	TABLET, EXTENDED RELEASE · ORAL 10MG FDA marketing: RX	2010 DEEP_REVIEW FINAL	15
OXYCODONE HYDROCHLORIDE OXYCONTIN	022272 Product 022272/002	TABLET, EXTENDED RELEASE · ORAL 15MG FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	15
OXYCODONE HYDROCHLORIDE OXYCONTIN	022272 Product 022272/003	TABLET, EXTENDED RELEASE · ORAL 20MG FDA marketing: RX	2010 DEEP_REVIEW FINAL	15
OXYCODONE HYDROCHLORIDE OXYCONTIN	022272 Product 022272/004	TABLET, EXTENDED RELEASE · ORAL 30MG FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	15
OXYCODONE HYDROCHLORIDE OXYCONTIN	022272 Product 022272/005	TABLET, EXTENDED RELEASE · ORAL 40MG FDA marketing: RX	2010 DEEP_REVIEW FINAL	14
OXYCODONE HYDROCHLORIDE OXYCONTIN	022272 Product 022272/006	TABLET, EXTENDED RELEASE · ORAL 60MG FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	14
OXYCODONE HYDROCHLORIDE OXYCONTIN	022272 Product 022272/007	TABLET, EXTENDED RELEASE · ORAL 80MG FDA marketing: RX	2010 DEEP_REVIEW FINAL	14
OXYCODONE HYDROCHLORIDE ROXYBOND	209777 Product 209777/001	TABLET · ORAL 5MG FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	2
OXYCODONE HYDROCHLORIDE ROXYBOND	209777 Product 209777/002	TABLET · ORAL 15MG FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	2
OXYCODONE HYDROCHLORIDE ROXYBOND	209777 Product 209777/003	TABLET · ORAL 30MG FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	2
OXYCODONE HYDROCHLORIDE ROXYBOND	209777 Product 209777/004	TABLET · ORAL 10MG FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	2
OXYGEN OXYGEN, USP	205712 Product 205712/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	205713 Product 205713/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	205737 Product 205737/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	205767 Product 205767/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	205817 Product 205817/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	205818 Product 205818/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	205820 Product 205820/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	205827 Product 205827/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	205840 Product 205840/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	205849 Product 205849/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	205862 Product 205862/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	205865 Product 205865/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	205889 Product 205889/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	205986 Product 205986/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	206023 Product 206023/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	210844 Product 210844/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	211739 Product 211739/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	212314 Product 212314/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	214857 Product 214857/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYGEN OXYGEN, USP	217500 Product 217500/001	GAS · INHALATION N/A FDA marketing: Prescription	Master only	0
OXYMETAZOLINE HYDROCHLORIDE RHOFADE	208552 Product 208552/001	CREAM · TOPICAL 1% FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	7
OXYMETAZOLINE HYDROCHLORIDE UPNEEQ	212520 Product 212520/001	SOLUTION/DROPS · OPHTHALMIC 0.1% FDA marketing: Prescription	2031 DEEP_REVIEW FINAL_CHECKING	14
OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE KOVANAZE	208032 Product 208032/001	SPRAY, METERED · NASAL 0.1MG/SPRAY;6MG/SPRAY FDA marketing: Prescription	2020 DEEP_REVIEW FINAL_CHECKING	2
OXYMORPHONE HYDROCHLORIDE OPANA ER	201655 Product 201655/001	TABLET, EXTENDED RELEASE · ORAL 5MG FDA marketing: WITHDRAWN	2020 WITHDRAWN FINAL	3
OXYMORPHONE HYDROCHLORIDE OPANA ER	201655 Product 201655/002	TABLET, EXTENDED RELEASE · ORAL 7.5MG FDA marketing: WITHDRAWN	2020 WITHDRAWN FINAL	3
OXYMORPHONE HYDROCHLORIDE OPANA ER	201655 Product 201655/003	TABLET, EXTENDED RELEASE · ORAL 10MG FDA marketing: WITHDRAWN	2020 WITHDRAWN FINAL	3
OXYMORPHONE HYDROCHLORIDE OPANA ER	201655 Product 201655/004	TABLET, EXTENDED RELEASE · ORAL 15MG FDA marketing: WITHDRAWN	2020 WITHDRAWN FINAL	3
OXYMORPHONE HYDROCHLORIDE OPANA ER	201655 Product 201655/005	TABLET, EXTENDED RELEASE · ORAL 20MG FDA marketing: WITHDRAWN	2020 WITHDRAWN FINAL	3
OXYMORPHONE HYDROCHLORIDE OPANA ER	201655 Product 201655/006	TABLET, EXTENDED RELEASE · ORAL 30MG FDA marketing: WITHDRAWN	2020 WITHDRAWN FINAL	3
OXYMORPHONE HYDROCHLORIDE OPANA ER	201655 Product 201655/007	TABLET, EXTENDED RELEASE · ORAL 40MG FDA marketing: WITHDRAWN	2020 WITHDRAWN FINAL	3
OXYTOCIN PITOCIN	018261 Product 018261/003	INJECTABLE · INJECTION 500USP UNITS/50ML (10USP UNITS/ML) FDA marketing: Prescription	2012 DEEP_REVIEW FINAL	0
OZANIMOD HYDROCHLORIDE ZEPOSIA	209899 Product 209899/001	CAPSULE · ORAL EQ 0.23MG BASE FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	5
OZANIMOD HYDROCHLORIDE ZEPOSIA	209899 Product 209899/002	CAPSULE · ORAL EQ 0.46MG BASE FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	5
OZANIMOD HYDROCHLORIDE ZEPOSIA	209899 Product 209899/003	CAPSULE · ORAL EQ 0.92MG BASE FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	5
OZENOXACIN XEPI	208945 Product 208945/001	CREAM · TOPICAL 1% FDA marketing: Discontinued	2024 DISCONTINUED FINAL	2
PACLITAXEL PACLITAXEL	211875 Product 211875/001	POWDER · INTRAVENOUS 100MG/VIAL FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
PACLITAXEL PACLITAXEL	216338 Product 216338/001	POWDER · INTRAVENOUS 100MG/VIAL FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
PACRITINIB CITRATE VONJO	208712 Product 208712/001	CAPSULE · ORAL EQ 100MG BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	3
PAFOLACIANINE SODIUM CYTALUX	214907 Product 214907/001	SOLUTION · INTRAVENOUS EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) FDA marketing: Prescription	2021 EXCLUDED FINAL	6
PALBOCICLIB IBRANCE	207103 Product 207103/001	CAPSULE · ORAL 75MG FDA marketing: RX	2027 DEEP_REVIEW FINAL	2
PALBOCICLIB IBRANCE	207103 Product 207103/002	CAPSULE · ORAL 100MG FDA marketing: RX	2027 DEEP_REVIEW FINAL	2
PALBOCICLIB IBRANCE	207103 Product 207103/003	CAPSULE · ORAL 125MG FDA marketing: RX	2027 DEEP_REVIEW FINAL	2
PALBOCICLIB IBRANCE	212436 Product 212436/001	TABLET · ORAL 75MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	3
PALBOCICLIB IBRANCE	212436 Product 212436/002	TABLET · ORAL 100MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	3
PALBOCICLIB IBRANCE	212436 Product 212436/003	TABLET · ORAL 125MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	3
PALIPERIDONE PALMITATE ERZOFRI	216352 Product 216352/001	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 39MG/0.25ML (39MG/0.25ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	2
PALIPERIDONE PALMITATE ERZOFRI	216352 Product 216352/002	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 78MG/0.5ML (78MG/0.5ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	2
PALIPERIDONE PALMITATE ERZOFRI	216352 Product 216352/003	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 117MG/0.75ML (117MG/0.75ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	2
PALIPERIDONE PALMITATE ERZOFRI	216352 Product 216352/004	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 156MG/ML (156MG/ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	2
PALIPERIDONE PALMITATE ERZOFRI	216352 Product 216352/005	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 234MG/1.5ML (156MG/ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	2
PALIPERIDONE PALMITATE ERZOFRI	216352 Product 216352/006	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 351MG/2.25ML (156MG/ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	2
PALIPERIDONE PALMITATE INVEGA HAFYERA	207946 Product 207946/005	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 1.092GM/3.5ML (312MG/ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	4
PALIPERIDONE PALMITATE INVEGA HAFYERA	207946 Product 207946/006	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 1.560GM/5ML (312MG/ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	4
PALIPERIDONE PALMITATE INVEGA TRINZA	207946 Product 207946/001	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 273MG/0.875ML (273MG/0.875ML) FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	1
PALIPERIDONE PALMITATE INVEGA TRINZA	207946 Product 207946/002	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 410MG/1.315ML (311.79MG/ML) FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	1
PALIPERIDONE PALMITATE INVEGA TRINZA	207946 Product 207946/003	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 546MG/1.75ML (312MG/ML) FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	1
PALIPERIDONE PALMITATE INVEGA TRINZA	207946 Product 207946/004	SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 819MG/2.625ML (312MG/ML) FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	1
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE	207963 Product 207963/001	SOLUTION · INTRAVENOUS EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	0
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE	208109 Product 208109/001	SOLUTION · INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
PALONOSETRON HYDROCHLORIDE POSFREA	203050 Product 203050/001	SOLUTION · INTRAVENOUS EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) FDA marketing: Discontinued	2017 DISCONTINUED FINAL	0
PALONOSETRON HYDROCHLORIDE POSFREA	203050 Product 203050/002	SOLUTION · INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
PALOPEGTERIPARATIDE YORVIPATH	216490 Product 216490/001	SOLUTION · SUBCUTANEOUS EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML) FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	9
PALOPEGTERIPARATIDE YORVIPATH	216490 Product 216490/002	SOLUTION · SUBCUTANEOUS EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML) FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	9
PALOPEGTERIPARATIDE YORVIPATH	216490 Product 216490/003	SOLUTION · SUBCUTANEOUS EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML) FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	9
PALOVAROTENE SOHONOS	215559 Product 215559/001	CAPSULE · ORAL 1MG FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	9
PALOVAROTENE SOHONOS	215559 Product 215559/002	CAPSULE · ORAL 1.5MG FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	9
PALOVAROTENE SOHONOS	215559 Product 215559/003	CAPSULE · ORAL 2.5MG FDA marketing: Discontinued	2026 DISCONTINUED FINAL	9
PALOVAROTENE SOHONOS	215559 Product 215559/004	CAPSULE · ORAL 5MG FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	9
PALOVAROTENE SOHONOS	215559 Product 215559/005	CAPSULE · ORAL 10MG FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	9
PALTUSOTINE HYDROCHLORIDE PALSONIFY	219070 Product 219070/001	TABLET · ORAL EQ 20MG BASE FDA marketing: Prescription	2041 DEEP_REVIEW FINAL	9
PALTUSOTINE HYDROCHLORIDE PALSONIFY	219070 Product 219070/002	TABLET · ORAL EQ 30MG BASE FDA marketing: Prescription	2041 DEEP_REVIEW FINAL	9
pancrelipase Pancreaze	022523 Product 022523/001	Capsule, Delayed Release · Oral 4,200USP UNITS; 14,200USP UNITS; 24,600USP UNITS FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
pancrelipase Pancreaze	022523 Product 022523/002	Capsule, Delayed Release · Oral 10,500USP UNITS; 35,500USP UNITS; 61,500USP UNITS FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
pancrelipase Pancreaze	022523 Product 022523/003	Capsule, Delayed Release · Oral 16,800USP UNITS; 56,800USP UNITS; 98,400USP UNITS FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
pancrelipase Pancreaze	022523 Product 022523/004	Capsule, Delayed Release · Oral 21,000USP UNITS; 54,700USP UNITS; 83,900USP UNITS FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
pancrelipase Pancreaze	022523 Product 022523/005	Capsule, Delayed Release · Oral 2,600USP UNITS; 8,800USP UNITS; 15,200USP UNITS FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	0
pancrelipase Pancreaze	022523 Product 022523/006	Capsule, Delayed Release · Oral 37,000USP UNITS; 97,300USP UNITS; 149,900USP UNITS FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	1
pancrelipase Pertzye	022175 Product 022175/001	Capsule, Delayed Release · Oral 8,000USP UNITS; 28,750USP UNITS; 30,250USP UNITS FDA marketing: Prescription	2012 DEEP_REVIEW FINAL	0
pancrelipase Pertzye	022175 Product 022175/002	Capsule, Delayed Release · Oral 16,000USP UNITS; 57,500USP UNITS; 60,500USP UNITS FDA marketing: Prescription	2012 DEEP_REVIEW FINAL	0
pancrelipase Pertzye	022175 Product 022175/003	Capsule, Delayed Release · Oral 4,000USP UNITS; 14,375USP UNITS; 15,125USP UNITS FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
pancrelipase Pertzye	022175 Product 022175/004	Capsule, Delayed Release · Oral 24,000USP UNITS; 86,250USP UNITS; 90,750USP UNITS FDA marketing: Prescription	2017 DEEP_REVIEW FINAL	0
pancrelipase Viokace	022542 Product 022542/001	Tablet · Oral 10,440USP UNITS; 39,150USP UNITS; 39,150USP UNITS FDA marketing: Prescription	2012 DEEP_REVIEW FINAL	0
pancrelipase Viokace	022542 Product 022542/002	Tablet · Oral 20,880USP UNITS; 78,300USP UNITS; 78,300USP UNITS FDA marketing: Prescription	2012 DEEP_REVIEW FINAL	0
PANOBINOSTAT LACTATE FARYDAK	205353 Product 205353/001	CAPSULE · ORAL EQ 10MG BASE FDA marketing: DISCONTINUED	2022 DISQUALIFIED FINAL	2
PANOBINOSTAT LACTATE FARYDAK	205353 Product 205353/002	CAPSULE · ORAL EQ 15MG BASE FDA marketing: DISCONTINUED	2022 DISQUALIFIED FINAL	2
PANOBINOSTAT LACTATE FARYDAK	205353 Product 205353/003	CAPSULE · ORAL EQ 20MG BASE FDA marketing: DISCONTINUED	2022 DISQUALIFIED FINAL	2
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM	209463 Product 209463/001	POWDER · INTRAVENOUS EQ 40MG BASE/VIAL FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	217512 Product 217512/001	SOLUTION · INTRAVENOUS EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML) FDA marketing: Prescription	2011 CANDIDATE FINAL	1
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	217512 Product 217512/002	SOLUTION · INTRAVENOUS EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) FDA marketing: Prescription	2011 CANDIDATE FINAL	1
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	217512 Product 217512/003	SOLUTION · INTRAVENOUS EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML) FDA marketing: Prescription	2011 CANDIDATE FINAL	1
parathyroid hormone Natpara	125511 Product 125511/001	For Injection · Subcutaneous 25MCG Multi-Dose Vial FDA marketing: Prescription	2027 CANDIDATE FINAL	0
parathyroid hormone Natpara	125511 Product 125511/002	For Injection · Subcutaneous 50MCG Multi-Dose Vial FDA marketing: Prescription	2027 CANDIDATE FINAL	0
parathyroid hormone Natpara	125511 Product 125511/003	For Injection · Subcutaneous 75MCG Multi-Dose Vial FDA marketing: Prescription	2027 CANDIDATE FINAL	0
parathyroid hormone Natpara	125511 Product 125511/004	For Injection · Subcutaneous 100MCG Multi-Dose Vial FDA marketing: Prescription	2027 CANDIDATE FINAL	0
PARICALCITOL PARICALCITOL	201657 Product 201657/001	SOLUTION · INTRAVENOUS 0.002MG/ML (0.002MG/ML) FDA marketing: WITHDRAWN	2026 WITHDRAWN FINAL	0
PARICALCITOL PARICALCITOL	201657 Product 201657/002	SOLUTION · INTRAVENOUS 0.005MG/ML (0.005MG/ML) FDA marketing: WITHDRAWN	2026 WITHDRAWN FINAL	0
PARICALCITOL PARICALCITOL	201657 Product 201657/003	SOLUTION · INTRAVENOUS 0.01MG/2ML (0.005MG/ML) FDA marketing: WITHDRAWN	2026 WITHDRAWN FINAL	0
PARICALCITOL PARICALCITOL	205917 Product 205917/001	SOLUTION · INTRAVENOUS 0.002MG/ML (0.002MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
PARICALCITOL PARICALCITOL	205917 Product 205917/002	SOLUTION · INTRAVENOUS 0.005MG/ML (0.005MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
PARICALCITOL PARICALCITOL	205917 Product 205917/003	SOLUTION · INTRAVENOUS 0.01MG/2ML (0.005MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
PARICALCITOL PARICALCITOL	207174 Product 207174/001	SOLUTION · INTRAVENOUS 0.002MG/ML (0.002MG/ML) FDA marketing: Prescription	2011 EXISTING_GENERIC DISQUALIFIED	0
PARICALCITOL PARICALCITOL	207174 Product 207174/002	SOLUTION · INTRAVENOUS 0.005MG/ML (0.005MG/ML) FDA marketing: Prescription	2011 EXISTING_GENERIC DISQUALIFIED	0
PARICALCITOL PARICALCITOL	207174 Product 207174/003	SOLUTION · INTRAVENOUS 0.01MG/2ML (0.005MG/ML) FDA marketing: Prescription	2011 EXISTING_GENERIC DISQUALIFIED	0
PAROXETINE MESYLATE BRISDELLE	204516 Product 204516/001	CAPSULE · ORAL EQ 7.5MG BASE FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	3
PASIREOTIDE DIASPARTATE SIGNIFOR	200677 Product 200677/001	SOLUTION · SUBCUTANEOUS EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML) FDA marketing: Prescription	2026 CANDIDATE FINAL	1
PASIREOTIDE DIASPARTATE SIGNIFOR	200677 Product 200677/002	SOLUTION · SUBCUTANEOUS EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML) FDA marketing: Prescription	2026 CANDIDATE FINAL	1
PASIREOTIDE DIASPARTATE SIGNIFOR	200677 Product 200677/003	SOLUTION · SUBCUTANEOUS EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML) FDA marketing: Prescription	2026 CANDIDATE FINAL	1
PASIREOTIDE PAMOATE SIGNIFOR LAR KIT	203255 Product 203255/001	FOR SUSPENSION · INTRAMUSCULAR EQ 20MG BASE/VIAL FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	3
PASIREOTIDE PAMOATE SIGNIFOR LAR KIT	203255 Product 203255/002	FOR SUSPENSION · INTRAMUSCULAR EQ 40MG BASE/VIAL FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	3
PASIREOTIDE PAMOATE SIGNIFOR LAR KIT	203255 Product 203255/003	FOR SUSPENSION · INTRAMUSCULAR EQ 60MG BASE/VIAL FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	3
PASIREOTIDE PAMOATE SIGNIFOR LAR KIT	203255 Product 203255/004	FOR SUSPENSION · INTRAMUSCULAR EQ 10MG BASE/VIAL FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	3
PASIREOTIDE PAMOATE SIGNIFOR LAR KIT	203255 Product 203255/005	FOR SUSPENSION · INTRAMUSCULAR EQ 30MG BASE/VIAL FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	3
PATIROMER SORBITEX CALCIUM VELTASSA	205739 Product 205739/001	POWDER · ORAL EQ 8.4GM BASE/PACKET FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	7
PATIROMER SORBITEX CALCIUM VELTASSA	205739 Product 205739/002	POWDER · ORAL EQ 16.8GM BASE/PACKET FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	7
PATIROMER SORBITEX CALCIUM VELTASSA	205739 Product 205739/003	POWDER · ORAL EQ 25.2GM BASE/PACKET FDA marketing: DISCONTINUED	2024 DISQUALIFIED FINAL	7
PATIROMER SORBITEX CALCIUM VELTASSA	205739 Product 205739/004	POWDER · ORAL EQ 1GM BASE/PACKET FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	7
PATISIRAN SODIUM ONPATTRO	210922 Product 210922/001	SOLUTION · INTRAVENOUS EQ 10MG BASE/5ML (EQ 2MG BASE/ML) FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	13
PEGCETACOPLAN EMPAVELI	215014 Product 215014/001	SOLUTION · SUBCUTANEOUS 1080MG/20ML (54MG/ML) FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	11
PEGCETACOPLAN SYFOVRE	217171 Product 217171/001	SOLUTION · INTRAVITREAL 15MG/0.1ML (15MG/0.1ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	13
pegfilgrastim Neulasta	125031 Product 125031/001	Injection · Subcutaneous 6MG/0.6ML Pre-Filled Syringe FDA marketing: Rx	2014 DEEP_REVIEW FINAL	1
pegfilgrastim Neulasta Onpro	125031 Product 125031/002	Injection · Subcutaneous 6MG/0.6ML Pre-Filled Syringe FDA marketing: Rx	2014 DEEP_REVIEW FINAL	1
pegfilgrastim-apgf Nyvepria	761111 Product 761111/001	Injection · Subcutaneous 6MG/0.6ML Pre-Filled Syringe FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	0
pegfilgrastim-bmez Ziextenzo	761045 Product 761045/001	Injection · Subcutaneous 6MG/0.6ML Pre-Filled Syringe FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	0
pegfilgrastim-cbqv Udenyca	761039 Product 761039/001	Injection · Subcutaneous 6MG/0.6ML Pre-Filled Syringe FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	0
pegfilgrastim-fpgk Stimufend	761173 Product 761173/001	Injection · Subcutaneous 6MG/0.6ML Pre-Filled Syringe FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	0
pegfilgrastim-jmdb Fulphila	761075 Product 761075/001	Injection · Subcutaneous 6MG/0.6ML Pre-Filled Syringe FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	0
pegfilgrastim-pbbk Fylnetra	761084 Product 761084/001	Injection · Subcutaneous 6MG/0.6ML Pre-Filled Syringe FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	0
pegfilgrastim-pccg Ennumo	761147 Product 761147/001	Injection · Subcutaneous 6MG/0.6ML Pre-Filled Syringe FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	0
pegfilgrastim-unne Armlupeg	761212 Product 761212/001	Injection · Subcutaneous 6MG/0.6ML Pre-Filled Syringe FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	0
PEGINESATIDE ACETATE OMONTYS	202799 Product 202799/007	SOLUTION · INTRAVENOUS, SUBCUTANEOUS EQ 10MG BASE/ML (EQ 10MG BASE/ML) FDA marketing: Discontinued	2013 DISCONTINUED FINAL	2
PEGINESATIDE ACETATE OMONTYS	202799 Product 202799/008	SOLUTION · INTRAVENOUS, SUBCUTANEOUS EQ 20MG BASE/2ML (EQ 10MG BASE/ML) FDA marketing: Discontinued	2013 DISCONTINUED FINAL	2
PEGINESATIDE ACETATE OMONTYS PRESERVATIVE FREE	202799 Product 202799/001	SOLUTION · INTRAVENOUS, SUBCUTANEOUS EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML) FDA marketing: Discontinued	2013 DISCONTINUED FINAL	2
PEGINESATIDE ACETATE OMONTYS PRESERVATIVE FREE	202799 Product 202799/002	SOLUTION · INTRAVENOUS, SUBCUTANEOUS EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML) FDA marketing: Discontinued	2013 DISCONTINUED FINAL	2
PEGINESATIDE ACETATE OMONTYS PRESERVATIVE FREE	202799 Product 202799/003	SOLUTION · INTRAVENOUS, SUBCUTANEOUS EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) FDA marketing: Discontinued	2013 DISCONTINUED FINAL	2
PEGINESATIDE ACETATE OMONTYS PRESERVATIVE FREE	202799 Product 202799/004	SOLUTION · INTRAVENOUS, SUBCUTANEOUS EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML) FDA marketing: Discontinued	2013 DISCONTINUED FINAL	2
PEGINESATIDE ACETATE OMONTYS PRESERVATIVE FREE	202799 Product 202799/005	SOLUTION · INTRAVENOUS, SUBCUTANEOUS EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML) FDA marketing: Discontinued	2013 DISCONTINUED FINAL	2
PEGINESATIDE ACETATE OMONTYS PRESERVATIVE FREE	202799 Product 202799/006	SOLUTION · INTRAVENOUS, SUBCUTANEOUS EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML) FDA marketing: Discontinued	2013 DISCONTINUED FINAL	2
peginterferon beta-1a Plegridy	125499 Product 125499/001	Injection · Subcutaneous 125MCG/0.5ML Autoinjector FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
pegloticase Krystexxa	125293 Product 125293/001	Injection · Intravenous 8MG/ML Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
PEGULICIANINE ACETATE LUMISIGHT	214511 Product 214511/001	POWDER · INTRAVENOUS EQ 39MG BASE/VIAL FDA marketing: Prescription	2024 EXCLUDED FINAL	6
pegunigalsidase alfa-iwxj Elfabrio	761161 Product 761161/001	Injection · Intravenous 20MG/10ML (2MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	2
pegvaliase-pqpz Palynziq	761079 Product 761079/001	Injection · Subcutaneous 2.5MG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	0
pegvaliase-pqpz Palynziq	761079 Product 761079/002	Injection · Subcutaneous 10MG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	0
pegvaliase-pqpz Palynziq	761079 Product 761079/003	Injection · Subcutaneous 20MG/ML Pre-Filled Syringe FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	0
PEGZILARGINASE-NBLN LOARGYS	761211 Product 761211/001	Injectable · Injection 0.1MG/KG FDA marketing: Prescription	Master only	0
pembrolizumab Keytruda	125514 Product 125514/002	Injection · Intravenous 100MG/4ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	0
pembrolizumab and berahyaluronidase alfa-pmph Keytruda Qlex	761467 Product 761467/001	Injection · Subcutaneous 395MG/2.4ML; 4,800UNITS/2.4ML (165MG/2,000UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2043 CANDIDATE FINAL_CHECKING	7
pembrolizumab and berahyaluronidase alfa-pmph Keytruda Qlex	761467 Product 761467/002	Injection · Subcutaneous 790MG/4.8ML; 9,600UNITS/4.8ML (165MG/2,000UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2043 CANDIDATE FINAL_CHECKING	7
PEMETREXED PEMETREXED	208419 Product 208419/001	SOLUTION · INTRAVENOUS 100MG/4ML (25MG/ML) FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	0
PEMETREXED PEMETREXED	208419 Product 208419/002	SOLUTION · INTRAVENOUS 500MG/20ML (25MG/ML) FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	0
PEMETREXED PEMETREXED	208419 Product 208419/003	SOLUTION · INTRAVENOUS 1GM/40ML (25MG/ML) FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	0
PEMETREXED PEMFEXY	209472 Product 209472/001	SOLUTION · INTRAVENOUS 500MG/20ML (25MG/ML) FDA marketing: Prescription	Master only	3
PEMETREXED DIPOTASSIUM AXTLE	210661 Product 210661/001	POWDER · INTRAVENOUS EQ 100MG BASE/VIAL FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	1
PEMETREXED DIPOTASSIUM AXTLE	210661 Product 210661/002	POWDER · INTRAVENOUS EQ 500MG BASE/VIAL FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	1
PEMETREXED DISODIUM PEMETREXED	215179 Product 215179/001	SOLUTION · INTRAVENOUS EQ 100MG/10ML BASE (10MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
PEMETREXED DISODIUM PEMETREXED	215179 Product 215179/002	SOLUTION · INTRAVENOUS EQ 500MG/50ML BASE (10MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
PEMETREXED DISODIUM PEMETREXED	215179 Product 215179/003	SOLUTION · INTRAVENOUS EQ 1GM/100ML BASE (10MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
PEMETREXED DISODIUM PEMETREXED DISODIUM	214218 Product 214218/001	SOLUTION · INTRAVENOUS EQ 100MG BASE/4ML (EQ 25MG BASE/ML) FDA marketing: Prescription	2022 CANDIDATE FINAL	2
PEMETREXED DISODIUM PEMETREXED DISODIUM	214218 Product 214218/002	SOLUTION · INTRAVENOUS EQ 500MG BASE/20ML (EQ 25MG BASE/ML) FDA marketing: Prescription	2022 CANDIDATE FINAL	2
PEMETREXED DISODIUM PEMETREXED DISODIUM	214218 Product 214218/003	SOLUTION · INTRAVENOUS EQ 1GM BASE/40ML (EQ 25MG BASE/ML) FDA marketing: Prescription	2022 CANDIDATE FINAL	2
PEMETREXED DISODIUM PEMETREXED DISODIUM	214408 Product 214408/001	SOLUTION · INTRAVENOUS EQ 100MG BASE/4ML (EQ 25MG BASE/ML) FDA marketing: Discontinued	2025 DISQUALIFIED FINAL	2
PEMETREXED DISODIUM PEMETREXED DISODIUM	214408 Product 214408/002	SOLUTION · INTRAVENOUS EQ 500MG BASE/20ML (EQ 25MG BASE/ML) FDA marketing: Discontinued	2025 DISQUALIFIED FINAL	2
PEMETREXED DISODIUM PEMETREXED DISODIUM	214408 Product 214408/003	SOLUTION · INTRAVENOUS EQ 850MG BASE/34ML (EQ 25MG BASE/ML) FDA marketing: Discontinued	2025 DISQUALIFIED FINAL	2
PEMETREXED DISODIUM PEMETREXED DISODIUM	214408 Product 214408/004	SOLUTION · INTRAVENOUS EQ 1GM BASE/40ML (EQ 25MG BASE/ML) FDA marketing: Discontinued	2025 DISQUALIFIED FINAL	2
PEMETREXED DISODIUM PEMETREXED DISODIUM	214657 Product 214657/001	SOLUTION · INTRAVENOUS EQ 100MG BASE/4ML (EQ 25MG BASE/ML) FDA marketing: Prescription	2022 CANDIDATE FINAL	2
PEMETREXED DISODIUM PEMETREXED DISODIUM	214657 Product 214657/002	SOLUTION · INTRAVENOUS EQ 500MG BASE/20ML (EQ 25MG BASE/ML) FDA marketing: Prescription	2022 CANDIDATE FINAL	2
PEMETREXED DISODIUM PEMETREXED DISODIUM	214657 Product 214657/003	SOLUTION · INTRAVENOUS EQ 1GM BASE/40ML (EQ 25MG BASE/ML) FDA marketing: Prescription	2022 CANDIDATE FINAL	2
PEMETREXED DITROMETHAMINE PEMETREXED DITROMETHAMINE	208746 Product 208746/001	POWDER · INTRAVENOUS EQ 100MG BASE/VIAL FDA marketing: Discontinued	2025 DISQUALIFIED FINAL	2
PEMETREXED DITROMETHAMINE PEMETREXED DITROMETHAMINE	208746 Product 208746/002	POWDER · INTRAVENOUS EQ 500MG BASE/VIAL FDA marketing: Discontinued	2025 DISQUALIFIED FINAL	2
PEMETREXED DITROMETHAMINE PEMETREXED DITROMETHAMINE	208746 Product 208746/003	POWDER · INTRAVENOUS EQ 1GM BASE/VIAL FDA marketing: Discontinued	2022 DISQUALIFIED FINAL	2
PEMIGATINIB PEMAZYRE	213736 Product 213736/001	TABLET · ORAL 4.5MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	5
PEMIGATINIB PEMAZYRE	213736 Product 213736/002	TABLET · ORAL 9MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	5
PEMIGATINIB PEMAZYRE	213736 Product 213736/003	TABLET · ORAL 13.5MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	5
penpulimab-kcqx N/A	761258 Product 761258/001	Injection · Intravenous 100MG/10ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2037 DEEP_REVIEW FINAL_CHECKING	0
PERAMIVIR RAPIVAB	206426 Product 206426/001	SOLUTION · INTRAVENOUS 200MG/20ML (10MG/ML) FDA marketing: Prescription	2027 CANDIDATE FINAL	2
PERAMPANEL FYCOMPA	202834 Product 202834/001	TABLET · ORAL 2MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
PERAMPANEL FYCOMPA	202834 Product 202834/002	TABLET · ORAL 4MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
PERAMPANEL FYCOMPA	202834 Product 202834/003	TABLET · ORAL 6MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
PERAMPANEL FYCOMPA	202834 Product 202834/004	TABLET · ORAL 8MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
PERAMPANEL FYCOMPA	202834 Product 202834/005	TABLET · ORAL 10MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
PERAMPANEL FYCOMPA	202834 Product 202834/006	TABLET · ORAL 12MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
PERAMPANEL FYCOMPA	208277 Product 208277/001	SUSPENSION · ORAL 0.5MG/ML FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
PERAMPANEL PERAMPANEL	220492 Product 220492/001	TABLET · ORAL 2MG FDA marketing: Prescription	Master only	0
PERAMPANEL PERAMPANEL	220492 Product 220492/002	TABLET · ORAL 4MG FDA marketing: Prescription	Master only	0
PERAMPANEL PERAMPANEL	220492 Product 220492/003	TABLET · ORAL 6MG FDA marketing: Prescription	Master only	0
PERAMPANEL PERAMPANEL	220492 Product 220492/004	TABLET · ORAL 8MG FDA marketing: Prescription	Master only	0
PERAMPANEL PERAMPANEL	220492 Product 220492/005	TABLET · ORAL 10MG FDA marketing: Prescription	Master only	0
PERAMPANEL PERAMPANEL	220492 Product 220492/006	TABLET · ORAL 12MG FDA marketing: Prescription	Master only	0
PERFLUOROHEXYLOCTANE MIEBO	216675 Product 216675/001	SOLUTION/DROPS · OPHTHALMIC 1.338GM/ML FDA marketing: Prescription	2035 DEEP_REVIEW FINAL_CHECKING	10
PERFLUTREN DEFINITY RT	021064 Product 021064/002	INJECTABLE · INTRAVENOUS 13.04MG/2ML (6.52MG/ML) FDA marketing: Prescription	2020 EXCLUDED FINAL	11
pertuzumab Perjeta	125409 Product 125409/001	Injection · Intravenous 420MG/14ML Single-Dose Vial FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	47
pertuzumab-dpzb Poherdy	761450 Product 761450/001	Injection · Intravenous 420MG/14ML (30MG/ML) Single-Dose Vial FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
pertuzumab, trastuzumab, and hyaluronidase-zzxf Phesgo	761170 Product 761170/001	Injection · Subcutaneous 1,200MG, 600MG, 30,000UNITS/15ML (80MG, 40MG, 2,000UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	0
pertuzumab, trastuzumab, and hyaluronidase-zzxf Phesgo	761170 Product 761170/002	Injection · Subcutaneous 600MG, 600MG, 20,000UNITS/10ML (60MG, 60MG, 2,000UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	0
PEXIDARTINIB HYDROCHLORIDE TURALIO	211810 Product 211810/001	CAPSULE · ORAL EQ 200MG BASE FDA marketing: DISCONTINUED	2023 DISQUALIFIED FINAL	12
PEXIDARTINIB HYDROCHLORIDE TURALIO	211810 Product 211810/002	CAPSULE · ORAL EQ 125MG BASE FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	12
PHENOBARBITAL SODIUM SEZABY	215910 Product 215910/001	POWDER · INTRAVENOUS 100MG/VIAL FDA marketing: Prescription	2029 DEEP_REVIEW FINAL_CHECKING	2
PHENTERMINE HYDROCHLORIDE SUPRENZA	202088 Product 202088/001	TABLET, ORALLY DISINTEGRATING · ORAL 15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2011 DEEP_REVIEW FINAL_CHECKING	1
PHENTERMINE HYDROCHLORIDE SUPRENZA	202088 Product 202088/002	TABLET, ORALLY DISINTEGRATING · ORAL 30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2011 DEEP_REVIEW FINAL_CHECKING	1
PHENTERMINE HYDROCHLORIDE SUPRENZA	202088 Product 202088/003	TABLET, ORALLY DISINTEGRATING · ORAL 37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2012 DEEP_REVIEW FINAL_CHECKING	1
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE QSYMIA	022580 Product 022580/001	CAPSULE, EXTENDED RELEASE · ORAL EQ 3.75MG BASE;23MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	6
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE QSYMIA	022580 Product 022580/002	CAPSULE, EXTENDED RELEASE · ORAL EQ 7.5MG BASE;46MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	6
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE QSYMIA	022580 Product 022580/003	CAPSULE, EXTENDED RELEASE · ORAL EQ 11.25MG BASE;69MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	6
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE QSYMIA	022580 Product 022580/004	CAPSULE, EXTENDED RELEASE · ORAL EQ 15MG BASE;92MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	6
PHENTOLAMINE MESYLATE RYZUMVI	217064 Product 217064/001	SOLUTION · OPHTHALMIC EQ 0.75% BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	13
PHENYLEPHRINE HYDROCHLORIDE BIORPHEN	212909 Product 212909/001	SOLUTION · INTRAVENOUS 0.5MG/5ML (0.1MG/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
PHENYLEPHRINE HYDROCHLORIDE BIORPHEN	212909 Product 212909/002	SOLUTION · INTRAVENOUS 10MG/ML (10MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
PHENYLEPHRINE HYDROCHLORIDE IMMPHENTIV	203826 Product 203826/004	SOLUTION · INTRAVENOUS 0.5MG/5ML (0.1MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	3
PHENYLEPHRINE HYDROCHLORIDE IMMPHENTIV	203826 Product 203826/005	SOLUTION · INTRAVENOUS 1MG/10ML (0.1MG/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	3
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE	203510 Product 203510/001	SOLUTION/DROPS · OPHTHALMIC 2.5% FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	1
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE	203510 Product 203510/002	SOLUTION/DROPS · OPHTHALMIC 10% FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	1
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE	203826 Product 203826/001	SOLUTION · INTRAVENOUS 10MG/ML (10MG/ML) FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE	203826 Product 203826/002	SOLUTION · INTRAVENOUS 50MG/5ML (10MG/ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE	203826 Product 203826/003	SOLUTION · INTRAVENOUS 100MG/10ML (10MG/ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE	207926 Product 207926/001	SOLUTION/DROPS · OPHTHALMIC 2.5% FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE	207926 Product 207926/002	SOLUTION/DROPS · OPHTHALMIC 10% FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE	215268 Product 215268/001	SOLUTION · INTRAVENOUS 10MG/ML (10MG/ML) FDA marketing: Prescription	Master only	0
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	216830 Product 216830/001	SOLUTION · INTRAVENOUS 20MG/250ML (0.08MG/ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	1
PHENYLEPHRINE HYDROCHLORIDE VAZCULEP	204300 Product 204300/001	SOLUTION · INTRAVENOUS 10MG/ML (10MG/ML) FDA marketing: Discontinued	2026 WITHDRAWN FINAL	0
PHENYLEPHRINE HYDROCHLORIDE VAZCULEP	204300 Product 204300/002	SOLUTION · INTRAVENOUS 50MG/5ML (10MG/ML) FDA marketing: Discontinued	2026 WITHDRAWN FINAL	0
PHENYLEPHRINE HYDROCHLORIDE VAZCULEP	204300 Product 204300/003	SOLUTION · INTRAVENOUS 100MG/10ML (10MG/ML) FDA marketing: Discontinued	2026 WITHDRAWN FINAL	0
PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE MYDCOMBI	215352 Product 215352/001	SPRAY, METERED · OPHTHALMIC 2.5%;1% FDA marketing: Discontinued	2024 DISCONTINUED FINAL	3
PHYTONADIONE PHYTONADIONE	219175 Product 219175/001	INJECTABLE · INJECTION 1MG/0.5ML FDA marketing: Prescription	Master only	0
PIFLUFOLASTAT F-18 PYLARIFY	214793 Product 214793/001	SOLUTION · INTRAVENOUS 50ML (1-80mCi/ML) FDA marketing: Prescription	2021 EXCLUDED FINAL	6
PIFLUFOLASTAT F-18 PYLARIFY TRUVU	220089 Product 220089/001	SOLUTION · INTRAVENOUS 1mCi/mL-120mCi/mL FDA marketing: Prescription	2026 EXCLUDED FINAL	6
PILOCARPINE HYDROCHLORIDE ISOPTO CARPINE	200890 Product 200890/001	SOLUTION/DROPS · OPHTHALMIC 1% FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
PILOCARPINE HYDROCHLORIDE ISOPTO CARPINE	200890 Product 200890/002	SOLUTION/DROPS · OPHTHALMIC 2% FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
PILOCARPINE HYDROCHLORIDE ISOPTO CARPINE	200890 Product 200890/003	SOLUTION/DROPS · OPHTHALMIC 4% FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
PILOCARPINE HYDROCHLORIDE QLOSI	217836 Product 217836/001	SOLUTION/DROPS · OPHTHALMIC 0.4% FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	4
PILOCARPINE HYDROCHLORIDE VUITY	214028 Product 214028/001	SOLUTION/DROPS · OPHTHALMIC 1.25% FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	2
PIMAVANSERIN TARTRATE NUPLAZID	207318 Product 207318/001	TABLET · ORAL EQ 17MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2019 DISQUALIFIED FINAL	3
PIMAVANSERIN TARTRATE NUPLAZID	207318 Product 207318/002	TABLET · ORAL EQ 10MG BASE FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	5
PIMAVANSERIN TARTRATE NUPLAZID	210793 Product 210793/001	CAPSULE · ORAL EQ 34MG BASE FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	7
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	206056 Product 206056/001	POWDER · INTRAVENOUS EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	1
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	206056 Product 206056/002	POWDER · INTRAVENOUS EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	1
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	206056 Product 206056/003	POWDER · INTRAVENOUS EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	1
PIRFENIDONE ESBRIET	022535 Product 022535/001	CAPSULE · ORAL 267MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	19
PIRFENIDONE ESBRIET	208780 Product 208780/001	TABLET · ORAL 267MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	16
PIRFENIDONE ESBRIET	208780 Product 208780/002	TABLET · ORAL 534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2017 DISCONTINUED FINAL	16
PIRFENIDONE ESBRIET	208780 Product 208780/003	TABLET · ORAL 801MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	16
PIRTOBRUTINIB JAYPIRCA	216059 Product 216059/001	TABLET · ORAL 50MG FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	7
PIRTOBRUTINIB JAYPIRCA	216059 Product 216059/002	TABLET · ORAL 100MG FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	7
PITAVASTATIN MAGNESIUM ZYPITAMAG	208379 Product 208379/001	TABLET · ORAL EQ 1MG BASE FDA marketing: DISCONTINUED	2019 DISQUALIFIED FINAL	1
PITAVASTATIN MAGNESIUM ZYPITAMAG	208379 Product 208379/002	TABLET · ORAL EQ 2MG BASE FDA marketing: Prescription	2031 CANDIDATE FINAL	1
PITAVASTATIN MAGNESIUM ZYPITAMAG	208379 Product 208379/003	TABLET · ORAL EQ 4MG BASE FDA marketing: Prescription	2031 CANDIDATE FINAL	1
PITAVASTATIN SODIUM NIKITA	209875 Product 209875/001	TABLET · ORAL EQ 1MG BASE FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
PITAVASTATIN SODIUM NIKITA	209875 Product 209875/002	TABLET · ORAL EQ 2MG BASE FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
PITAVASTATIN SODIUM NIKITA	209875 Product 209875/003	TABLET · ORAL EQ 4MG BASE FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
PITOLISANT HYDROCHLORIDE PITOLISANT HYDROCHLORIDE	218832 Product 218832/001	TABLET · ORAL EQ 4.45MG BASE FDA marketing: Prescription	Master only	0
PITOLISANT HYDROCHLORIDE PITOLISANT HYDROCHLORIDE	218832 Product 218832/002	TABLET · ORAL EQ 17.8MG BASE FDA marketing: Prescription	Master only	0
PITOLISANT HYDROCHLORIDE WAKIX	211150 Product 211150/001	TABLET · ORAL EQ 4.45MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	3
PITOLISANT HYDROCHLORIDE WAKIX	211150 Product 211150/002	TABLET · ORAL EQ 17.8MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	3
pivekimab sunirine-pvzy Decnupaz	761460 Product 761460/001	For Injection · Intravenous 2MG Single-Dose Vial FDA marketing: Prescription	2038 CANDIDATE FINAL_CHECKING	1
PIVMECILLINAM HYDROCHLORIDE PIVYA	216483 Product 216483/001	TABLET · ORAL EQ 185MG BASE FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
PLAZOMICIN SULFATE ZEMDRI	210303 Product 210303/001	SOLUTION · INTRAVENOUS EQ 500MG BASE/10ML (EQ 50MG BASE/ML) FDA marketing: DISCONTINUED	2026 DISQUALIFIED FINAL	4
PLECANATIDE TRULANCE	208745 Product 208745/001	TABLET · ORAL 3MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	10
PLOZASIRAN SODIUM REDEMPLO	219947 Product 219947/001	SOLUTION · SUBCUTANEOUS EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) FDA marketing: Prescription	2038 CANDIDATE FINAL	5
polatuzumab vedotin-piiq Polivy	761121 Product 761121/001	For Injection · Intravenous 140MG Single-Dose Vial FDA marketing: Prescription	2033 CANDIDATE FINAL	0
polatuzumab vedotin-piiq Polivy	761121 Product 761121/002	For Injection · Intravenous 30MG Single-Dose Vial FDA marketing: Prescription	2033 CANDIDATE FINAL	0
POLIDOCANOL ASCLERA	021201 Product 021201/001	SOLUTION · INTRAVENOUS 10MG/2ML (5MG/ML) FDA marketing: Prescription	2015 CANDIDATE FINAL	0
POLIDOCANOL ASCLERA	021201 Product 021201/002	SOLUTION · INTRAVENOUS 20MG/2ML (10MG/ML) FDA marketing: Prescription	2015 CANDIDATE FINAL	0
POLIDOCANOL VARITHENA	205098 Product 205098/001	SOLUTION · INTRAVENOUS 180MG/18ML (10MG/ML) FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	2
POLIDOCANOL VARITHENA	205098 Product 205098/002	SOLUTION · INTRAVENOUS 77.5MG/7.75ML (10MG/ML) FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
POMALIDOMIDE POMALYST	204026 Product 204026/001	CAPSULE · ORAL 1MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	3
POMALIDOMIDE POMALYST	204026 Product 204026/002	CAPSULE · ORAL 2MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	3
POMALIDOMIDE POMALYST	204026 Product 204026/003	CAPSULE · ORAL 3MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	3
POMALIDOMIDE POMALYST	204026 Product 204026/004	CAPSULE · ORAL 4MG FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	3
PONATINIB HYDROCHLORIDE ICLUSIG	203469 Product 203469/001	TABLET · ORAL EQ 15MG BASE FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	6
PONATINIB HYDROCHLORIDE ICLUSIG	203469 Product 203469/002	TABLET · ORAL EQ 45MG BASE FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	6
PONATINIB HYDROCHLORIDE ICLUSIG	203469 Product 203469/003	TABLET · ORAL EQ 30MG BASE FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	6
PONATINIB HYDROCHLORIDE ICLUSIG	203469 Product 203469/004	TABLET · ORAL EQ 10MG BASE FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	6
PONESIMOD PONVORY	213498 Product 213498/001	TABLET · ORAL 2MG FDA marketing: Prescription	2042 DEEP_REVIEW FINAL	6
PONESIMOD PONVORY	213498 Product 213498/002	TABLET · ORAL 3MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	8
PONESIMOD PONVORY	213498 Product 213498/003	TABLET · ORAL 4MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	8
PONESIMOD PONVORY	213498 Product 213498/004	TABLET · ORAL 5MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	8
PONESIMOD PONVORY	213498 Product 213498/005	TABLET · ORAL 6MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	8
PONESIMOD PONVORY	213498 Product 213498/006	TABLET · ORAL 7MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	8
PONESIMOD PONVORY	213498 Product 213498/007	TABLET · ORAL 8MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	8
PONESIMOD PONVORY	213498 Product 213498/008	TABLET · ORAL 9MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	8
PONESIMOD PONVORY	213498 Product 213498/009	TABLET · ORAL 10MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	8
PONESIMOD PONVORY	213498 Product 213498/010	TABLET · ORAL 20MG FDA marketing: Prescription	2042 DEEP_REVIEW FINAL	6
POSACONAZOLE NOXAFIL	205053 Product 205053/001	TABLET, DELAYED RELEASE · ORAL 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2019 DISQUALIFIED FINAL	0
POSACONAZOLE NOXAFIL	205596 Product 205596/001	SOLUTION · INTRAVENOUS 300MG/16.7ML (18MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	6
POSACONAZOLE NOXAFIL POWDERMIX KIT	214770 Product 214770/001	FOR SUSPENSION, DELAYED RELEASE · ORAL 300MG FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
POTASSIUM CHLORIDE K-TAB	018279 Product 018279/003	TABLET, EXTENDED RELEASE · ORAL 20MEQ FDA marketing: Discontinued	2023 DISCONTINUED FINAL	0
POTASSIUM CHLORIDE POKONZA	206814 Product 206814/003	SOLUTION · ORAL 10MEQ/15ML FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	2
POTASSIUM CHLORIDE POKONZA	208019 Product 208019/002	FOR SOLUTION · ORAL 10MEQ FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
POTASSIUM CHLORIDE POKONZA	208019 Product 208019/004	FOR SOLUTION · ORAL 15MEQ FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	1
POTASSIUM CHLORIDE POTASSIUM CHLORIDE	206814 Product 206814/001	SOLUTION · ORAL 20MEQ/15ML FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	2
POTASSIUM CHLORIDE POTASSIUM CHLORIDE	206814 Product 206814/002	SOLUTION · ORAL 40MEQ/15ML FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	2
POTASSIUM CHLORIDE POTASSIUM CHLORIDE	208019 Product 208019/001	FOR SOLUTION · ORAL 20MEQ FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
POTASSIUM CHLORIDE POTASSIUM CHLORIDE	208019 Product 208019/003	FOR SOLUTION · ORAL 40MEQ FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	0
POTASSIUM IODIDE IOSAT	018664 Product 018664/002	TABLET · ORAL 65MG FDA marketing: Over-the-counter	2011 EXCLUDED FINAL	0
POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATES	212121 Product 212121/001	SOLUTION · INTRAVENOUS 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) FDA marketing: Discontinued	2025 WITHDRAWN FINAL	1
POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATES	212832 Product 212832/001	SOLUTION · INTRAVENOUS 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATES	212832 Product 212832/002	SOLUTION · INTRAVENOUS 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATES	212832 Product 212832/003	SOLUTION · INTRAVENOUS 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	212832 Product 212832/004	SOLUTION · INTRAVENOUS 1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	2
POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	212832 Product 212832/005	SOLUTION · INTRAVENOUS 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	2
POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	218343 Product 218343/001	SOLUTION · INTRAVENOUS 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL_CHECKING	1
pozelimab-bbfg Veopoz	761339 Product 761339/001	Injection · Intravenous, Subcutaneous 400MG/2ML (200MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 DEEP_REVIEW FINAL_CHECKING	1
prabotulinumtoxinA-xvfs Jeuveau	761085 Product 761085/001	For Injection · Intramuscular 100UNITS Single-Dose Vial FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	0
PRALSETINIB GAVRETO	213721 Product 213721/001	CAPSULE · ORAL 100MG FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	8
PRAMIPEXOLE DIHYDROCHLORIDE MIRAPEX ER	022421 Product 022421/001	TABLET, EXTENDED RELEASE · ORAL 0.375MG FDA marketing: Discontinued	DISCONTINUED FINAL	2
PRAMIPEXOLE DIHYDROCHLORIDE MIRAPEX ER	022421 Product 022421/002	TABLET, EXTENDED RELEASE · ORAL 0.75MG FDA marketing: Discontinued	DISCONTINUED FINAL	2
PRAMIPEXOLE DIHYDROCHLORIDE MIRAPEX ER	022421 Product 022421/003	TABLET, EXTENDED RELEASE · ORAL 1.5MG FDA marketing: Discontinued	DISCONTINUED FINAL	2
PRAMIPEXOLE DIHYDROCHLORIDE MIRAPEX ER	022421 Product 022421/004	TABLET, EXTENDED RELEASE · ORAL 3MG FDA marketing: Discontinued	DISCONTINUED FINAL	2
PRAMIPEXOLE DIHYDROCHLORIDE MIRAPEX ER	022421 Product 022421/005	TABLET, EXTENDED RELEASE · ORAL 4.5MG FDA marketing: Discontinued	DISCONTINUED FINAL	2
PRAMIPEXOLE DIHYDROCHLORIDE MIRAPEX ER	022421 Product 022421/006	TABLET, EXTENDED RELEASE · ORAL 2.25MG FDA marketing: Discontinued	DISCONTINUED FINAL	2
PRAMIPEXOLE DIHYDROCHLORIDE MIRAPEX ER	022421 Product 022421/007	TABLET, EXTENDED RELEASE · ORAL 3.75MG FDA marketing: Discontinued	DISCONTINUED FINAL	2
PRASTERONE INTRAROSA	208470 Product 208470/001	INSERT · VAGINAL 6.5MG FDA marketing: Prescription	2030 DEEP_REVIEW FINAL_CHECKING	3
PREDNISOLONE ACETATE PREDNISOLONE ACETATE	212778 Product 212778/001	SUSPENSION/DROPS · OPHTHALMIC 1% FDA marketing: Prescription	Master only	0
PREDNISONE RAYOS	202020 Product 202020/001	TABLET, DELAYED RELEASE · ORAL 1MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	1
PREDNISONE RAYOS	202020 Product 202020/002	TABLET, DELAYED RELEASE · ORAL 2MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	1
PREDNISONE RAYOS	202020 Product 202020/003	TABLET, DELAYED RELEASE · ORAL 5MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	2
PREGABALIN LYRICA	022488 Product 022488/001	SOLUTION · ORAL 20MG/ML FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	0
PREGABALIN LYRICA CR	209501 Product 209501/001	TABLET, EXTENDED RELEASE · ORAL 82.5MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	3
PREGABALIN LYRICA CR	209501 Product 209501/002	TABLET, EXTENDED RELEASE · ORAL 165MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	3
PREGABALIN LYRICA CR	209501 Product 209501/003	TABLET, EXTENDED RELEASE · ORAL 330MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	3
PRETOMANID PRETOMANID	212862 Product 212862/001	TABLET · ORAL 200MG FDA marketing: Prescription	2031 CANDIDATE FINAL	0
PRITELIVIR HOVILPR	221154 Product 221154/001	TABLET · ORAL 100MG FDA marketing: Prescription	Master only	0
PROBENECID; SULOPENEM ETZADROXIL ORLYNVAH	213972 Product 213972/001	TABLET · ORAL 500MG;500MG FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	5
PROGESTERONE MILPROSA	201110 Product 201110/001	SYSTEM · VAGINAL 1.78GM FDA marketing: Discontinued	DISCONTINUED FINAL	3
PROGESTERONE PROGESTERONE	219588 Product 219588/001	INSERT · VAGINAL 100MG FDA marketing: Prescription	Master only	0
PROPRANOLOL HYDROCHLORIDE HEMANGEOL	205410 Product 205410/001	SOLUTION · ORAL 4.28MG/ML FDA marketing: Prescription	2028 CANDIDATE FINAL	2
PRUCALOPRIDE SUCCINATE MOTEGRITY	210166 Product 210166/001	TABLET · ORAL EQ 1MG BASE FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
PRUCALOPRIDE SUCCINATE MOTEGRITY	210166 Product 210166/002	TABLET · ORAL EQ 2MG BASE FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
PURIFIED WATER PUR-WASH	022305 Product 022305/001	SOLUTION · OPHTHALMIC 98.3% FDA marketing: Over-the-counter	2011 EXCLUDED FINAL	0
PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE	217604 Product 217604/001	TABLET, EXTENDED RELEASE · ORAL 105MG FDA marketing: Discontinued	2024 DISCONTINUED FINAL	9
QUIZARTINIB DIHYDROCHLORIDE VANFLYTA	216993 Product 216993/001	TABLET · ORAL EQ 17.7MG BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	11
QUIZARTINIB DIHYDROCHLORIDE VANFLYTA	216993 Product 216993/002	TABLET · ORAL EQ 26.5MG BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL	11
RABEPRAZOLE SODIUM ACIPHEX SPRINKLE	204736 Product 204736/001	CAPSULE, DELAYED RELEASE · ORAL 5MG FDA marketing: Discontinued	2021 WITHDRAWN FINAL	1
RABEPRAZOLE SODIUM ACIPHEX SPRINKLE	204736 Product 204736/002	CAPSULE, DELAYED RELEASE · ORAL 10MG FDA marketing: Discontinued	2021 WITHDRAWN FINAL	1
RADIUM RA-223 DICHLORIDE XOFIGO	203971 Product 203971/001	SOLUTION · INTRAVENOUS 162mCi/6ML (27mCi/ML) FDA marketing: Prescription	2022 CANDIDATE FINAL	1
RALTEGRAVIR POTASSIUM ISENTRESS	203045 Product 203045/001	TABLET, CHEWABLE · ORAL EQ 25MG BASE FDA marketing: Prescription	2011 DEEP_REVIEW FINAL	1
RALTEGRAVIR POTASSIUM ISENTRESS	203045 Product 203045/002	TABLET, CHEWABLE · ORAL EQ 100MG BASE FDA marketing: Prescription	2011 DEEP_REVIEW FINAL	2
RALTEGRAVIR POTASSIUM ISENTRESS	205786 Product 205786/001	POWDER · ORAL EQ 100MG BASE/PACKET FDA marketing: Prescription	2013 DEEP_REVIEW FINAL	1
RALTEGRAVIR POTASSIUM ISENTRESS HD	022145 Product 022145/002	TABLET · ORAL EQ 600MG BASE FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	4
RAMIPRIL VOSTALLY	219757 Product 219757/001	SOLUTION · ORAL 1MG/ML FDA marketing: Discontinued	2026 DISCONTINUED FINAL	1
ramucirumab Cyramza	125477 Product 125477/001	Injection · Intravenous 100MG/10ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
ramucirumab Cyramza	125477 Product 125477/002	Injection · Intravenous 500MG/50ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
ranibizumab Lucentis	125156 Product 125156/001	Injection · Intravitreal 10MG/ML (0.5MG/0.05ML) Single-Dose Vial FDA marketing: Disc*	2023 DISCONTINUED FINAL	11
ranibizumab Lucentis	125156 Product 125156/002	Injection · Intravitreal 6MG/ML (0.3MG/0.05ML) Single-Dose Vial FDA marketing: Disc*	2023 DISCONTINUED FINAL	11
ranibizumab Lucentis	125156 Product 125156/003	Injection · Intravitreal 10MG/ML (0.5MG/0.05ML) Pre-Filled Syringe FDA marketing: Rx	2020 DEEP_REVIEW FINAL	11
ranibizumab Lucentis	125156 Product 125156/004	Injection · Intravitreal 6MG/ML (0.3MG/0.05ML) Pre-Filled Syringe FDA marketing: Rx	2020 DEEP_REVIEW FINAL	11
ranibizumab Susvimo	761197 Product 761197/001	Injection · Intravitreal 100MG/ML Single-Dose Vial FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	0
ranibizumab-eqrn Cimerli	761165 Product 761165/001	Injection · Intravitreal 10MG/ML (0.5MG/0.05ML) Single-Dose Vial FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	0
ranibizumab-eqrn Cimerli	761165 Product 761165/002	Injection · Intravitreal 6MG/ML (0.3MG/0.05ML) Single-Dose Vial FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	0
RANIBIZUMAB-HKDZ RANLUSPEC	761480 Product 761480/001	INJECTION 10MG/ML FDA marketing: Prescription	Master only	0
RANIBIZUMAB-HKDZ RANLUSPEC	761480 Product 761480/002	INJECTION 6MG/ML FDA marketing: Prescription	Master only	0
ranibizumab-leyk Nufymco	761473 Product 761473/001	Injection · Intravitreal 10MG/ML (0.5MG/0.05ML) Single-Dose Vial FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	0
ranibizumab-leyk Nufymco	761473 Product 761473/002	Injection · Intravitreal 6MG/ML (0.3MG/0.05ML) Single-Dose Vial FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	0
ranibizumab-nuna Byooviz	761202 Product 761202/001	Injection · Intravitreal 10MG/ML (0.5MG/0.05ML) Single-Dose Vial FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	0
RANOLAZINE ASPRUZYO SPRINKLE	216018 Product 216018/001	GRANULE, EXTENDED RELEASE · ORAL 500MG FDA marketing: Discontinued	2024 DISCONTINUED FINAL	1
RANOLAZINE ASPRUZYO SPRINKLE	216018 Product 216018/002	GRANULE, EXTENDED RELEASE · ORAL 1GM FDA marketing: Discontinued	2024 DISCONTINUED FINAL	3
ravulizumab-cwvz Ultomiris	761108 Product 761108/001	Injection · Intravenous 300MG/30ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 CANDIDATE FINAL	0
raxibacumab N/A	125349 Product 125349/001	Injection · Intravenous 1,700MG/34ML (50MG/ML) Single-Dose Vial FDA marketing: Prescription	2025 CANDIDATE FINAL	0
REGORAFENIB STIVARGA	203085 Product 203085/001	TABLET · ORAL 40MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	4
RELACORILANT LIFYORLI (COPACKAGED)	220641 Product 220641/001	CAPSULE · ORAL 100MG;25MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	10
RELUGOLIX ORGOVYX	214621 Product 214621/001	TABLET · ORAL 120MG FDA marketing: RX	2037 CANDIDATE FINAL	12
REMDESIVIR VEKLURY	214787 Product 214787/001	POWDER · INTRAVENOUS 100MG/VIAL FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	16
REMDESIVIR VEKLURY	214787 Product 214787/002	SOLUTION · INTRAVENOUS 100MG/20ML (5MG/ML) FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	13
REMIBRUTINIB RHAPSIDO	218436 Product 218436/001	TABLET · ORAL 25MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	3
REMIMAZOLAM BESYLATE BYFAVO	212295 Product 212295/001	POWDER · INTRAVENOUS EQ 20MG BASE/VIAL FDA marketing: Prescription	2034 CANDIDATE FINAL	11
REPOSITORY CORTICOTROPIN H.P. ACTHAR GEL	022432 Product 022432/001	INJECTABLE · INJECTION 80 UNITS/ML FDA marketing: Prescription	Master only	0
REPOTRECTINIB AUGTYRO	218213 Product 218213/001	CAPSULE · ORAL 40MG FDA marketing: Prescription	2036 CANDIDATE FINAL	5
REPOTRECTINIB AUGTYRO	218213 Product 218213/002	CAPSULE · ORAL 160MG FDA marketing: Prescription	2036 CANDIDATE FINAL	5
reslizumab Cinqair	761033 Product 761033/001	Injection · Intravenous 100MG/10ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2028 CANDIDATE FINAL	0
RESMETIROM REZDIFFRA	217785 Product 217785/001	TABLET · ORAL 60MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	7
RESMETIROM REZDIFFRA	217785 Product 217785/002	TABLET · ORAL 80MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	8
RESMETIROM REZDIFFRA	217785 Product 217785/003	TABLET · ORAL 100MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	7
RETAPAMULIN ALTABAX	022055 Product 022055/001	OINTMENT · TOPICAL 1% 15 g / 30 g tube (historical FDA labeling; one exact product) FDA marketing: Discontinued	2024 DISCONTINUED FINAL	3
retifanlimab-dlwr Zynyz	761334 Product 761334/001	Injection · Intravenous 500MG/20ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2037 CANDIDATE FINAL_CHECKING	1
REVEFENACIN YUPELRI	210598 Product 210598/001	SOLUTION · INHALATION 175MCG/3ML FDA marketing: RX	2028 DEEP_REVIEW FINAL	10
REVUMENIB CITRATE REVUFORJ	218944 Product 218944/001	TABLET · ORAL EQ 25MG BASE FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	3
REVUMENIB CITRATE REVUFORJ	218944 Product 218944/002	TABLET · ORAL EQ 110MG BASE FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	3
REVUMENIB CITRATE REVUFORJ	218944 Product 218944/003	TABLET · ORAL EQ 160MG BASE FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	3
REZAFUNGIN ACETATE REZZAYO	217417 Product 217417/001	POWDER · INTRAVENOUS EQ 200MG BASE/VIAL FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	7
RIBOCICLIB SUCCINATE KISQALI	209092 Product 209092/001	TABLET · ORAL EQ 200MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	12
RIBOFLAVIN 5'-PHOSPHATE SODIUM EPIOXA HD/EPIOXA KIT	219910 Product 219910/001	SOLUTION/DROPS · OPHTHALMIC EQ 0.239% BASE/ML;EQ 0.177% BASE/ML FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	2
RIBOFLAVIN 5'-PHOSPHATE SODIUM PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA	203324 Product 203324/001	SOLUTION/DROPS · OPHTHALMIC EQ 0.146% BASE/ML;EQ 0.146% BASE/ML FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
RIFAMYCIN SODIUM AEMCOLO	210910 Product 210910/001	TABLET, DELAYED RELEASE · ORAL EQ 194MG BASE FDA marketing: Discontinued	2024 EXCLUDED FINAL	0
RIFAXIMIN XIFAXAN	021361 Product 021361/002	TABLET · ORAL 550MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	19
RILPIVIRINE HYDROCHLORIDE EDURANT	202022 Product 202022/001	TABLET · ORAL EQ 25MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	0
RILPIVIRINE HYDROCHLORIDE EDURANT PED	219016 Product 219016/001	TABLET, FOR SUSPENSION · ORAL EQ 2.5MG BASE FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	1
RILUZOLE EXSERVAN	212640 Product 212640/001	FILM · ORAL 50MG FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	2
RILUZOLE TIGLUTIK KIT	209080 Product 209080/001	SUSPENSION · ORAL 50MG/10ML FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	1
RILZABRUTINIB WAYRILZ	219685 Product 219685/001	TABLET · ORAL 400MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	6
RIMEGEPANT SULFATE NURTEC ODT	212728 Product 212728/001	TABLET, ORALLY DISINTEGRATING · ORAL EQ 75MG BASE FDA marketing: Prescription	Master only	3
RIOCIGUAT ADEMPAS	204819 Product 204819/001	TABLET · ORAL 0.5MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	4
RIOCIGUAT ADEMPAS	204819 Product 204819/002	TABLET · ORAL 1MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	4
RIOCIGUAT ADEMPAS	204819 Product 204819/003	TABLET · ORAL 1.5MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	4
RIOCIGUAT ADEMPAS	204819 Product 204819/004	TABLET · ORAL 2MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	4
RIOCIGUAT ADEMPAS	204819 Product 204819/005	TABLET · ORAL 2.5MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	4
RIPRETINIB QINLOCK	213973 Product 213973/001	TABLET · ORAL 50MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	42
risankizumab-rzaa Skyrizi	761105 Product 761105/001	Injection · Subcutaneous 75MG/0.83ML Pre-Filled Syringe FDA marketing: Prescription	2023 DISCONTINUED FINAL	0
risankizumab-rzaa Skyrizi	761105 Product 761105/002	Injection · Subcutaneous 150MG/ML Pre-Filled Syringe FDA marketing: Prescription	2031 DEEP_REVIEW FINAL_CHECKING	1
risankizumab-rzaa Skyrizi	761262 Product 761262/001	Injection · Intravenous 600MG/10ML (60MG/ML) Single-Dose Vial FDA marketing: Prescription	2031 DEEP_REVIEW FINAL_CHECKING	1
RISDIPLAM EVRYSDI	213535 Product 213535/001	FOR SOLUTION · ORAL 0.75MG/ML FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	7
RISDIPLAM EVRYSDI	219285 Product 219285/001	TABLET · ORAL 5MG FDA marketing: Prescription	2038 DEEP_REVIEW FINAL	6
RISEDRONATE SODIUM ATELVIA	022560 Product 022560/001	TABLET, DELAYED RELEASE · ORAL 35MG FDA marketing: Prescription	2015 EXISTING_GENERIC DISQUALIFIED	3
RISPERIDONE PERSERIS KIT	210655 Product 210655/001	FOR SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS 90MG FDA marketing: Discontinued	2026 DISCONTINUED FINAL	10
RISPERIDONE PERSERIS KIT	210655 Product 210655/002	FOR SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS 120MG FDA marketing: Discontinued	2026 DISCONTINUED FINAL	10
RISPERIDONE RISPERIDONE	077328 Product 077328/006	TABLET, ORALLY DISINTEGRATING · ORAL 0.25MG FDA marketing: Prescription	Master only	0
RISPERIDONE RISVAN	214835 Product 214835/001	FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 75MG FDA marketing: Discontinued	2024 DISCONTINUED FINAL	14
RISPERIDONE RISVAN	214835 Product 214835/002	FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 100MG FDA marketing: Discontinued	2024 DISCONTINUED FINAL	14
RISPERIDONE RYKINDO	212849 Product 212849/001	FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 12.5MG FDA marketing: Discontinued	2025 DISCONTINUED FINAL	5
RISPERIDONE RYKINDO	212849 Product 212849/002	FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 25MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	5
RISPERIDONE RYKINDO	212849 Product 212849/003	FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 37.5MG FDA marketing: Discontinued	2026 DISCONTINUED FINAL	5
RISPERIDONE RYKINDO	212849 Product 212849/004	FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR 50MG FDA marketing: Discontinued	2026 DISCONTINUED FINAL	5
RISPERIDONE UZEDY	213586 Product 213586/001	SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS 50MG/0.14ML (50MG/0.14ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	6
RISPERIDONE UZEDY	213586 Product 213586/002	SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS 75MG/0.21ML (75MG/0.21ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	6
RISPERIDONE UZEDY	213586 Product 213586/003	SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS 100MG/0.28ML (100MG/0.28ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL_CHECKING	6
RISPERIDONE UZEDY	213586 Product 213586/004	SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS 125MG/0.35ML (125MG/0.35ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	6
RISPERIDONE UZEDY	213586 Product 213586/005	SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS 150MG/0.42ML (150MG/0.42ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	6
RISPERIDONE UZEDY	213586 Product 213586/006	SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS 200MG/0.56ML (200MG/0.56ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	6
RISPERIDONE UZEDY	213586 Product 213586/007	SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS 250MG/0.7ML (250MG/0.7ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	6
RITLECITINIB TOSYLATE LITFULO	215830 Product 215830/001	CAPSULE · ORAL EQ 50MG BASE FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	3
RITONAVIR NORVIR	022417 Product 022417/001	TABLET · ORAL 100MG FDA marketing: Prescription	2015 EXISTING_GENERIC DISQUALIFIED	0
RITONAVIR NORVIR	209512 Product 209512/001	POWDER · ORAL 100MG/PACKET FDA marketing: Prescription	2017 DEEP_REVIEW PROVISIONAL	0
rituximab Rituxan	103705 Product 103705/001	Injection · Intravenous 100MG/10ML (10MG/ML) Single-Dose Vial FDA marketing: Rx	2009 DEEP_REVIEW FINAL	15
rituximab Rituxan	103705 Product 103705/002	Injection · Intravenous 500MG/50ML (10MG/ML) Single-Dose Vial FDA marketing: Rx	2009 DEEP_REVIEW FINAL	15
rituximab and hyaluronidase human Rituxan Hycela	761064 Product 761064/001	Injection · Subcutaneous 1,400MG/11.7ML; 23,400UNITS/11.7ML (120MG/2,000UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2030 CANDIDATE FINAL	0
rituximab and hyaluronidase human Rituxan Hycela	761064 Product 761064/002	Injection · Subcutaneous 1,600MG/13.4ML; 26,800UNITS/13.4ML (120MG/2,000UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2030 CANDIDATE FINAL	0
rituximab-abbs Truxima	761088 Product 761088/001	Injection · Intravenous 100MG/10ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	0
rituximab-abbs Truxima	761088 Product 761088/002	Injection · Intravenous 500MG/50ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	0
rituximab-arrx Riabni	761140 Product 761140/001	Injection · Intravenous 100MG/10ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2009 DEEP_REVIEW FINAL	0
rituximab-cdxx Zimrixby	761376 Product 761376/001	Injection · Intravenous 100MG/10ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2009 DEEP_REVIEW FINAL	0
rituximab-cdxx Zimrixby	761376 Product 761376/002	Injection · Intravenous 500MG/50ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2009 DEEP_REVIEW FINAL	0
rituximab-pvvr Ruxience	761103 Product 761103/001	Injection · Intravenous 100MG/10ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2009 DEEP_REVIEW FINAL	0
rituximab-pvvr Ruxience	761103 Product 761103/002	Injection · Intravenous 500MG/50ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2009 DEEP_REVIEW FINAL	0
RIVAROXABAN XARELTO	022406 Product 022406/001	TABLET · ORAL 10MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
RIVAROXABAN XARELTO	022406 Product 022406/002	TABLET · ORAL 15MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
RIVAROXABAN XARELTO	022406 Product 022406/003	TABLET · ORAL 20MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	1
RIVAROXABAN XARELTO	022406 Product 022406/004	TABLET · ORAL 2.5MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
RIVAROXABAN XARELTO	215859 Product 215859/001	FOR SUSPENSION · ORAL 1MG/ML FDA marketing: Discontinued	2025 EXISTING_GENERIC DISQUALIFIED	0
RIVAROXABAN YULZETY	221033 Product 221033/001	SUSPENSION · ORAL 2MG/ML FDA marketing: Prescription	2026 NEW_APPROVAL PROVISIONAL	0
RIVAROXABAN YULZETY	221033 Product 221033/002	SUSPENSION · ORAL 4MG/ML FDA marketing: Prescription	2026 NEW_APPROVAL PROVISIONAL	0
RIVASTIGMINE EXELON	022083 Product 022083/005	FILM, EXTENDED RELEASE · TRANSDERMAL 13.3MG/24HR FDA marketing: Prescription	2015 EXISTING_GENERIC DISQUALIFIED	0
RIZATRIPTAN BENZOATE RIZAFILM	205394 Product 205394/001	FILM · ORAL EQ 10MG BASE FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
RIZATRIPTAN BENZOATE RIZAFILM	205394 Product 205394/002	FILM · ORAL EQ 5MG BASE FDA marketing: Prescription	2026 DISQUALIFIED FINAL	2
ROCURONIUM BROMIDE ROCURONIUM BROMIDE	217472 Product 217472/001	SOLUTION · INTRAVENOUS 50MG/5ML (10MG/ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	1
ROCURONIUM BROMIDE ROCURONIUM BROMIDE	217472 Product 217472/002	SOLUTION · INTRAVENOUS 100MG/10ML (10MG/ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	1
ROCURONIUM BROMIDE ROCURONIUM BROMIDE	219108 Product 219108/001	SOLUTION · INTRAVENOUS 50MG/5ML (10MG/ML) FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	1
ROCURONIUM BROMIDE ROCURONIUM BROMIDE	219260 Product 219260/001	INJECTABLE · INJECTION 50MG/5ML (10MG/ML) FDA marketing: Prescription	Master only	0
ROCURONIUM BROMIDE ROCURONIUM BROMIDE	219260 Product 219260/002	INJECTABLE · INJECTION 100MG/10ML (10MG/ML) FDA marketing: Prescription	Master only	0
ROFLUMILAST DALIRESP	022522 Product 022522/001	TABLET · ORAL 500MCG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
ROFLUMILAST DALIRESP	022522 Product 022522/002	TABLET · ORAL 250MCG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
ROFLUMILAST ZORYVE	215985 Product 215985/001	CREAM · TOPICAL 0.3% FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	17
ROFLUMILAST ZORYVE	215985 Product 215985/002	CREAM · TOPICAL 0.15% FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	17
ROFLUMILAST ZORYVE	215985 Product 215985/003	CREAM · TOPICAL 0.05% FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	18
ROFLUMILAST ZORYVE	217242 Product 217242/001	FOAM · TOPICAL 0.3% FDA marketing: Prescription	2026 DEEP_REVIEW FINAL_CHECKING	21
ROLAPITANT HYDROCHLORIDE VARUBI	206500 Product 206500/001	TABLET · ORAL EQ 90MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	7
ROLAPITANT HYDROCHLORIDE VARUBI	208399 Product 208399/001	EMULSION · INTRAVENOUS EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML) FDA marketing: DISCONTINUED	2018 DISQUALIFIED FINAL	6
ROMIDEPSIN ROMIDEPSIN	208574 Product 208574/001	SOLUTION · INTRAVENOUS 10MG/2ML (5MG/ML) FDA marketing: Discontinued	2020 DISQUALIFIED FINAL	0
ROMIDEPSIN ROMIDEPSIN	208574 Product 208574/002	SOLUTION · INTRAVENOUS 27.5MG/5.5ML (5MG/ML) FDA marketing: Discontinued	2022 DISQUALIFIED FINAL	0
ROMIDEPSIN ROMIDEPSIN	220783 Product 220783/001	POWDER · INTRAVENOUS 10MG/VIAL FDA marketing: Prescription	Master only	0
romosozumab-aqqg Evenity	761062 Product 761062/001	Injection · Subcutaneous 105MG/1.17ML Pre-Filled Syringe FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	0
ropeginterferon alfa-2b-njft Besremi	761166 Product 761166/001	Injection · Subcutaneous 500MCG/ML Pre-Filled Syringe FDA marketing: Prescription	2033 CANDIDATE FINAL_CHECKING	1
ROPIVACAINE HYDROCHLORIDE NAROPIN	020533 Product 020533/009	SOLUTION · INJECTION 500MG/100ML (5MG/ML) FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
ROPIVACAINE HYDROCHLORIDE NAROPIN	020533 Product 020533/010	SOLUTION · INJECTION 1GM/200ML (5MG/ML) FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
ROSUVASTATIN CALCIUM EZALLOR SPRINKLE	208647 Product 208647/001	CAPSULE · ORAL EQ 5MG BASE FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
ROSUVASTATIN CALCIUM EZALLOR SPRINKLE	208647 Product 208647/002	CAPSULE · ORAL EQ 10MG BASE FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
ROSUVASTATIN CALCIUM EZALLOR SPRINKLE	208647 Product 208647/003	CAPSULE · ORAL EQ 20MG BASE FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
ROSUVASTATIN CALCIUM EZALLOR SPRINKLE	208647 Product 208647/004	CAPSULE · ORAL EQ 40MG BASE FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
ROTIGOTINE NEUPRO	021829 Product 021829/004	FILM, EXTENDED RELEASE · TRANSDERMAL 1MG/24HR FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	4
ROTIGOTINE NEUPRO	021829 Product 021829/005	FILM, EXTENDED RELEASE · TRANSDERMAL 3MG/24HR FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	4
ROTIGOTINE NEUPRO	021829 Product 021829/006	FILM, EXTENDED RELEASE · TRANSDERMAL 8MG/24HR FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	4
rozanolixizumab-noli Rystiggo	761286 Product 761286/001	Injection · Subcutaneous 280MG/2ML (140MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	1
RUBIDIUM CHLORIDE RB-82 RUBY-FILL	202153 Product 202153/001	SOLUTION · INTRAVENOUS N/A FDA marketing: Prescription	2016 EXCLUDED FINAL	0
RUCAPARIB CAMSYLATE RUBRACA	209115 Product 209115/001	TABLET · ORAL EQ 200MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	9
RUCAPARIB CAMSYLATE RUBRACA	209115 Product 209115/002	TABLET · ORAL EQ 300MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	9
RUCAPARIB CAMSYLATE RUBRACA	209115 Product 209115/003	TABLET · ORAL EQ 250MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	9
RUFINAMIDE BANZEL	201367 Product 201367/001	SUSPENSION · ORAL 40MG/ML FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	0
RUSFERTIDE ACETATE MIMRYLO	220605 Product 220605/001	POWDER · SUBCUTANEOUS EQ 9.5MG BASE/VIAL FDA marketing: Prescription	2034 CANDIDATE FINAL	6
RUSFERTIDE ACETATE MIMRYLO	220605 Product 220605/002	POWDER · SUBCUTANEOUS EQ 19MG BASE/VIAL FDA marketing: Prescription	2034 CANDIDATE FINAL	6
RUSFERTIDE ACETATE MIMRYLO	220605 Product 220605/003	POWDER · SUBCUTANEOUS EQ 28MG BASE/VIAL FDA marketing: Prescription	2034 CANDIDATE FINAL	6
RUSFERTIDE ACETATE MIMRYLO	220605 Product 220605/004	POWDER · SUBCUTANEOUS EQ 41MG BASE/VIAL FDA marketing: Prescription	2034 CANDIDATE FINAL	6
RUSFERTIDE ACETATE MIMRYLO	220605 Product 220605/005	POWDER · SUBCUTANEOUS EQ 54MG BASE/VIAL FDA marketing: Prescription	2034 CANDIDATE FINAL	6
RUXOLITINIB PHOSPHATE JAKAFI	202192 Product 202192/001	TABLET · ORAL EQ 5MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	8
RUXOLITINIB PHOSPHATE JAKAFI	202192 Product 202192/002	TABLET · ORAL EQ 10MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	8
RUXOLITINIB PHOSPHATE JAKAFI	202192 Product 202192/003	TABLET · ORAL EQ 15MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	8
RUXOLITINIB PHOSPHATE JAKAFI	202192 Product 202192/004	TABLET · ORAL EQ 20MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	8
RUXOLITINIB PHOSPHATE JAKAFI	202192 Product 202192/005	TABLET · ORAL EQ 25MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	8
RUXOLITINIB PHOSPHATE JAKAFI XR	217180 Product 217180/001	TABLET, EXTENDED RELEASE · ORAL EQ 11MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	17
RUXOLITINIB PHOSPHATE JAKAFI XR	217180 Product 217180/002	TABLET, EXTENDED RELEASE · ORAL EQ 22MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	17
RUXOLITINIB PHOSPHATE JAKAFI XR	217180 Product 217180/003	TABLET, EXTENDED RELEASE · ORAL EQ 33MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	17
RUXOLITINIB PHOSPHATE JAKAFI XR	217180 Product 217180/004	TABLET, EXTENDED RELEASE · ORAL EQ 44MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	17
RUXOLITINIB PHOSPHATE JAKAFI XR	217180 Product 217180/005	TABLET, EXTENDED RELEASE · ORAL EQ 55MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	17
RUXOLITINIB PHOSPHATE OPZELURA	215309 Product 215309/001	CREAM · TOPICAL EQ 1.5% BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	22
sacituzumab govitecan-hziy Trodelvy	761115 Product 761115/001	For Injection · Intravenous 180MG Single-Dose Vial FDA marketing: Prescription	2032 CANDIDATE FINAL	0
SACUBITRIL; VALSARTAN ENTRESTO	207620 Product 207620/001	TABLET · ORAL 24MG;26MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	6
SACUBITRIL; VALSARTAN ENTRESTO	207620 Product 207620/002	TABLET · ORAL 49MG;51MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	6
SACUBITRIL; VALSARTAN ENTRESTO	207620 Product 207620/003	TABLET · ORAL 97MG;103MG FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	6
SACUBITRIL; VALSARTAN ENTRESTO SPRINKLE	218591 Product 218591/001	CAPSULE, PELLETS · ORAL 6MG;6MG FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	3
SACUBITRIL; VALSARTAN ENTRESTO SPRINKLE	218591 Product 218591/002	CAPSULE, PELLETS · ORAL 15MG;16MG FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	3
SAFINAMIDE MESYLATE XADAGO	207145 Product 207145/001	TABLET · ORAL EQ 50MG BASE FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	3
SAFINAMIDE MESYLATE XADAGO	207145 Product 207145/002	TABLET · ORAL EQ 100MG BASE FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	3
SAPROPTERIN DIHYDROCHLORIDE KUVAN	205065 Product 205065/001	FOR SOLUTION · ORAL 100MG/PACKET FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	1
SAPROPTERIN DIHYDROCHLORIDE KUVAN	205065 Product 205065/002	FOR SOLUTION · ORAL 500MG/PACKET FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	1
SARECYCLINE HYDROCHLORIDE SEYSARA	209521 Product 209521/001	TABLET · ORAL EQ 60MG BASE FDA marketing: Prescription	Master only	4
SARECYCLINE HYDROCHLORIDE SEYSARA	209521 Product 209521/002	TABLET · ORAL EQ 100MG BASE FDA marketing: Prescription	Master only	4
SARECYCLINE HYDROCHLORIDE SEYSARA	209521 Product 209521/003	TABLET · ORAL EQ 150MG BASE FDA marketing: Prescription	Master only	4
sarilumab Kevzara	761037 Product 761037/001	Injection · Subcutaneous 150MG/1.14ML Pre-Filled Syringe FDA marketing: Prescription	2031 CANDIDATE FINAL	0
sarilumab Kevzara	761037 Product 761037/002	Injection · Subcutaneous 200MG/1.14ML Pre-Filled Syringe FDA marketing: Prescription	2031 CANDIDATE FINAL	0
satralizumab-mwge Enspryng	761149 Product 761149/001	Injection · Subcutaneous 120MG/ML Pre-Filled Syringe FDA marketing: Prescription	2033 CANDIDATE FINAL	0
sebelipase alfa Kanuma	125561 Product 125561/001	Injection · Intravenous 20MG/10ML (2MG/ML) Single-Dose Vial FDA marketing: Prescription	2027 CANDIDATE FINAL	0
SEBETRALSTAT EKTERLY	219301 Product 219301/001	TABLET · ORAL 300MG FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	8
SECNIDAZOLE SOLOSEC	209363 Product 209363/001	GRANULE · ORAL 2GM/PACKET FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	11
secukinumab Cosentyx	125504 Product 125504/001	Injection · Subcutaneous 150MG/ML Autoinjector FDA marketing: Prescription	2030 CANDIDATE FINAL	0
secukinumab Cosentyx	125504 Product 125504/003	For Injection · Subcutaneous 150MG Single-Dose Vial FDA marketing: Prescription	2023 WITHDRAWN FINAL	0
SELADELPAR LYSINE LIVDELZI	217899 Product 217899/001	CAPSULE · ORAL EQ 10MG BASE FDA marketing: Prescription	2038 CANDIDATE FINAL	6
SELENIOUS ACID SELENIOUS ACID	209379 Product 209379/001	SOLUTION · INTRAVENOUS EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	2
SELENIOUS ACID SELENIOUS ACID	209379 Product 209379/002	SOLUTION · INTRAVENOUS EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	2
SELENIOUS ACID SELENIOUS ACID	209379 Product 209379/003	SOLUTION · INTRAVENOUS EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	2
SELEXIPAG UPTRAVI	207947 Product 207947/001	TABLET · ORAL 0.2MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	6
SELEXIPAG UPTRAVI	207947 Product 207947/002	TABLET · ORAL 0.4MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	6
SELEXIPAG UPTRAVI	207947 Product 207947/003	TABLET · ORAL 0.6MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	6
SELEXIPAG UPTRAVI	207947 Product 207947/004	TABLET · ORAL 0.8MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	6
SELEXIPAG UPTRAVI	207947 Product 207947/005	TABLET · ORAL 1MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	6
SELEXIPAG UPTRAVI	207947 Product 207947/006	TABLET · ORAL 1.2MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	6
SELEXIPAG UPTRAVI	207947 Product 207947/007	TABLET · ORAL 1.4MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	6
SELEXIPAG UPTRAVI	207947 Product 207947/008	TABLET · ORAL 1.6MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	6
SELEXIPAG UPTRAVI	207947 Product 207947/010	TABLET · ORAL 0.1MG FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	6
SELEXIPAG UPTRAVI	207947 Product 207947/011	TABLET · ORAL 0.15MG FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	6
SELEXIPAG UPTRAVI	214275 Product 214275/001	POWDER · INTRAVENOUS 1.8MG/VIAL FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	4
SELINEXOR XPOVIO	212306 Product 212306/001	TABLET · ORAL 20MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	11
SELINEXOR XPOVIO	212306 Product 212306/002	TABLET · ORAL 40MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	11
SELINEXOR XPOVIO	212306 Product 212306/003	TABLET · ORAL 50MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	11
SELINEXOR XPOVIO	212306 Product 212306/004	TABLET · ORAL 60MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	11
SELINEXOR XPOVIO	212306 Product 212306/005	TABLET · ORAL 10MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	11
SELINEXOR XPOVIO	212306 Product 212306/006	TABLET · ORAL 80MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	11
SELPERCATINIB RETEVMO	213246 Product 213246/001	CAPSULE · ORAL 40MG FDA marketing: Prescription	2039 CANDIDATE FINAL	6
SELPERCATINIB RETEVMO	213246 Product 213246/002	CAPSULE · ORAL 80MG FDA marketing: Prescription	2039 CANDIDATE FINAL	6
SELPERCATINIB RETEVMO	218160 Product 218160/001	TABLET · ORAL 40MG FDA marketing: Prescription	2039 CANDIDATE FINAL	4
SELPERCATINIB RETEVMO	218160 Product 218160/002	TABLET · ORAL 80MG FDA marketing: Prescription	2039 CANDIDATE FINAL	4
SELPERCATINIB RETEVMO	218160 Product 218160/003	TABLET · ORAL 120MG FDA marketing: Prescription	2039 CANDIDATE FINAL	4
SELPERCATINIB RETEVMO	218160 Product 218160/004	TABLET · ORAL 160MG FDA marketing: Prescription	2039 CANDIDATE FINAL	4
SELUMETINIB SULFATE KOSELUGO	213756 Product 213756/001	CAPSULE · ORAL EQ 10MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	8
SELUMETINIB SULFATE KOSELUGO	213756 Product 213756/002	CAPSULE · ORAL EQ 25MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	8
SELUMETINIB SULFATE KOSELUGO	219943 Product 219943/001	GRANULE · ORAL EQ 5MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	4
SELUMETINIB SULFATE KOSELUGO	219943 Product 219943/002	GRANULE · ORAL EQ 7.5MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	4
SEMAGLUTIDE OZEMPIC	209637 Product 209637/001	SOLUTION · SUBCUTANEOUS 2MG/1.5ML (1.34MG/ML) FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	16
SEMAGLUTIDE OZEMPIC	209637 Product 209637/002	SOLUTION · SUBCUTANEOUS 4MG/3ML (1.34MG/ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	18
SEMAGLUTIDE OZEMPIC	209637 Product 209637/003	SOLUTION · SUBCUTANEOUS 8MG/3ML (2.68MG/ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	17
SEMAGLUTIDE OZEMPIC	209637 Product 209637/004	SOLUTION · SUBCUTANEOUS 2MG/3ML (0.68MG/ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	18
SEMAGLUTIDE OZEMPIC	209637 Product 209637/005	SOLUTION · SUBCUTANEOUS 0.25MG/0.5ML (0.25MG/0.5ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	6
SEMAGLUTIDE OZEMPIC	209637 Product 209637/006	SOLUTION · SUBCUTANEOUS 0.5MG/0.5ML (0.5MG/0.5ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	6
SEMAGLUTIDE OZEMPIC	209637 Product 209637/007	SOLUTION · SUBCUTANEOUS 1MG/0.5ML (1MG/0.5ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	8
SEMAGLUTIDE OZEMPIC	213051 Product 213051/004	TABLET · ORAL 1.5MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	9
SEMAGLUTIDE OZEMPIC	213051 Product 213051/005	TABLET · ORAL 4MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	9
SEMAGLUTIDE OZEMPIC	213051 Product 213051/006	TABLET · ORAL 9MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
SEMAGLUTIDE RYBELSUS	213051 Product 213051/001	TABLET · ORAL 3MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	15
SEMAGLUTIDE RYBELSUS	213051 Product 213051/002	TABLET · ORAL 7MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	15
SEMAGLUTIDE RYBELSUS	213051 Product 213051/003	TABLET · ORAL 14MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	15
SEMAGLUTIDE WEGOVY	215256 Product 215256/001	SOLUTION · SUBCUTANEOUS 0.25MG/0.5ML (0.25MG/0.5ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	8
SEMAGLUTIDE WEGOVY	215256 Product 215256/002	SOLUTION · SUBCUTANEOUS 0.5MG/0.5ML (0.5MG/0.5ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	8
SEMAGLUTIDE WEGOVY	215256 Product 215256/003	SOLUTION · SUBCUTANEOUS 1MG/0.5ML (1MG/0.5ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	8
SEMAGLUTIDE WEGOVY	215256 Product 215256/004	SOLUTION · SUBCUTANEOUS 1.7MG/0.75ML (1.7MG/0.75ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	8
SEMAGLUTIDE WEGOVY	215256 Product 215256/005	SOLUTION · SUBCUTANEOUS 2.4MG/0.75ML (2.4MG/0.75ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
SEMAGLUTIDE WEGOVY	215256 Product 215256/007	SOLUTION · SUBCUTANEOUS 0.25MG/0.5ML (0.25MG/0.5ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
SEMAGLUTIDE WEGOVY	215256 Product 215256/008	SOLUTION · SUBCUTANEOUS 0.5MG/0.5ML (0.5MG/0.5ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
SEMAGLUTIDE WEGOVY	215256 Product 215256/009	SOLUTION · SUBCUTANEOUS 1MG/0.5ML (1MG/0.5ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
SEMAGLUTIDE WEGOVY	215256 Product 215256/010	SOLUTION · SUBCUTANEOUS 1.7MG/0.75ML (1.7MG/0.75ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
SEMAGLUTIDE WEGOVY	215256 Product 215256/011	SOLUTION · SUBCUTANEOUS 2.4MG/0.75ML (2.4MG/0.75ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	10
SEMAGLUTIDE WEGOVY	218316 Product 218316/001	TABLET · ORAL 1.5MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	8
SEMAGLUTIDE WEGOVY	218316 Product 218316/002	TABLET · ORAL 4MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	8
SEMAGLUTIDE WEGOVY	218316 Product 218316/003	TABLET · ORAL 9MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	9
SEMAGLUTIDE WEGOVY	218316 Product 218316/004	TABLET · ORAL 25MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	9
SEMAGLUTIDE WEGOVY FLEXTOUCH	215256 Product 215256/012	SOLUTION · SUBCUTANEOUS 9.6MG/3ML (3.2MG/ML) FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	5
SEMAGLUTIDE WEGOVY HD	215256 Product 215256/006	SOLUTION · SUBCUTANEOUS 7.2MG/0.75ML (7.2MG/0.75ML) FDA marketing: Prescription	2038 DEEP_REVIEW FINAL	8
SEPIAPTERIN SEPHIENCE	219666 Product 219666/001	POWDER · ORAL 250MG/PACKET FDA marketing: Prescription	2042 CANDIDATE FINAL	4
SEPIAPTERIN SEPHIENCE	219666 Product 219666/002	POWDER · ORAL 1GM/PACKET FDA marketing: Prescription	2042 CANDIDATE FINAL	4
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE	077713 Product 077713/004	TABLET · ORAL EQ 150MG BASE FDA marketing: Prescription	Master only	0
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE	077713 Product 077713/005	TABLET · ORAL EQ 200MG BASE FDA marketing: Prescription	Master only	0
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE	215133 Product 215133/001	CAPSULE · ORAL EQ 150MG BASE FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE	215133 Product 215133/002	CAPSULE · ORAL EQ 200MG BASE FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
SETMELANOTIDE ACETATE IMCIVREE	213793 Product 213793/001	SOLUTION · SUBCUTANEOUS EQ 10MG BASE/ML (EQ 10MG BASE/ML) FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	3
SEVABERTINIB HYRNUO	219972 Product 219972/001	TABLET · ORAL 10MG FDA marketing: Prescription	2043 CANDIDATE FINAL	2
sibeprenlimab-szsi Voyxact	761434 Product 761434/001	Injection · Subcutaneous 400MG/2ML (200MG/ML) Pre-Filled Syringe FDA marketing: Prescription	2037 CANDIDATE FINAL_CHECKING	1
SILDENAFIL CITRATE LIQREV	214952 Product 214952/001	SUSPENSION · ORAL EQ 10MG BASE/ML FDA marketing: Discontinued	2024 DISCONTINUED FINAL	5
SILDENAFIL CITRATE REVATIO	203109 Product 203109/001	FOR SUSPENSION · ORAL EQ 10MG BASE/ML FDA marketing: Discontinued	DISCONTINUED FINAL	0
SILDENAFIL CITRATE VYBRIQUE	210858 Product 210858/001	FILM · ORAL EQ 25MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	1
SILDENAFIL CITRATE VYBRIQUE	210858 Product 210858/002	FILM · ORAL EQ 50MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	1
SILDENAFIL CITRATE VYBRIQUE	210858 Product 210858/003	FILM · ORAL EQ 75MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	1
SILDENAFIL CITRATE VYBRIQUE	210858 Product 210858/004	FILM · ORAL EQ 100MG BASE FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	1
siltuximab Sylvant	125496 Product 125496/001	For Injection · Intravenous 100MG Single-Dose Vial FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
siltuximab Sylvant	125496 Product 125496/002	For Injection · Intravenous 400MG Single-Dose Vial FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
SIMEPREVIR SODIUM OLYSIO	205123 Product 205123/001	CAPSULE · ORAL EQ 150MG BASE FDA marketing: DISCONTINUED	2018 DISQUALIFIED FINAL	8
SIMVASTATIN FLOLIPID	206679 Product 206679/001	SUSPENSION · ORAL 20MG/5ML FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	2
SIMVASTATIN FLOLIPID	206679 Product 206679/002	SUSPENSION · ORAL 40MG/5ML FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	2
SIMVASTATIN; SITAGLIPTIN PHOSPHATE JUVISYNC	202343 Product 202343/001	TABLET · ORAL 10MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2013 DISQUALIFIED FINAL	1
SIMVASTATIN; SITAGLIPTIN PHOSPHATE JUVISYNC	202343 Product 202343/002	TABLET · ORAL 20MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2013 DISQUALIFIED FINAL	1
SIMVASTATIN; SITAGLIPTIN PHOSPHATE JUVISYNC	202343 Product 202343/003	TABLET · ORAL 40MG;EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2013 DISQUALIFIED FINAL	1
SIMVASTATIN; SITAGLIPTIN PHOSPHATE JUVISYNC	202343 Product 202343/004	TABLET · ORAL 10MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2013 DISQUALIFIED FINAL	1
SIMVASTATIN; SITAGLIPTIN PHOSPHATE JUVISYNC	202343 Product 202343/005	TABLET · ORAL 20MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2013 DISQUALIFIED FINAL	1
SIMVASTATIN; SITAGLIPTIN PHOSPHATE JUVISYNC	202343 Product 202343/006	TABLET · ORAL 40MG;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2013 DISQUALIFIED FINAL	1
SINCALIDE SINCALIDE	210850 Product 210850/001	POWDER · INTRAVENOUS 0.005MG/VIAL FDA marketing: Prescription	2022 EXCLUDED FINAL	3
SIPONIMOD MAYZENT	209884 Product 209884/001	TABLET · ORAL EQ 0.25MG BASE FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	5
SIPONIMOD MAYZENT	209884 Product 209884/002	TABLET · ORAL EQ 2MG BASE FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	5
SIPONIMOD MAYZENT	209884 Product 209884/003	TABLET · ORAL EQ 1MG BASE FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	5
SIROLIMUS FYARRO	213312 Product 213312/001	POWDER · INTRAVENOUS 100MG/VIAL FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	7
SIROLIMUS HYFTOR	213478 Product 213478/001	GEL · TOPICAL 0.2% FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	1
SIROLIMUS RAPAMUNE	021110 Product 021110/004	TABLET · ORAL 0.5MG FDA marketing: Prescription	2014 EXISTING_GENERIC DISQUALIFIED	0
SITAGLIPTIN ZITUVIO	211566 Product 211566/001	TABLET · ORAL 25MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
SITAGLIPTIN ZITUVIO	211566 Product 211566/002	TABLET · ORAL 50MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
SITAGLIPTIN ZITUVIO	211566 Product 211566/003	TABLET · ORAL 100MG FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
SITAGLIPTIN HYDROCHLORIDE BRYNOVIN	219122 Product 219122/001	SOLUTION · ORAL EQ 25MG BASE/ML FDA marketing: Discontinued	2026 DISCONTINUED FINAL	2
SODIUM ACETATE SODIUM ACETATE	018893 Product 018893/002	SOLUTION · INTRAVENOUS 100MEQ/50ML (2MEQ/ML) FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
SODIUM ACETATE SODIUM ACETATE	018893 Product 018893/003	SOLUTION · INTRAVENOUS 200MEQ/100ML (2MEQ/ML) FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
SODIUM BENZOATE; SODIUM PHENYLACETATE SODIUM PHENYLACETATE AND SODIUM BENZOATE	215025 Product 215025/001	SOLUTION · INTRAVENOUS 10%;10% (2GM/20ML;2GM/20ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
SODIUM BICARBONATE SODIUM BICARBONATE	218524 Product 218524/001	SOLUTION · INTRAVENOUS 150MEQ/1000ML (0.15MEQ/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
SODIUM BICARBONATE SODIUM BICARBONATE	220790 Product 220790/001	SOLUTION · INTRAVENOUS 150MEQ/1000ML (0.15MEQ/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
SODIUM CHLORIDE SODIUM CHLORIDE 0.9%	019635 Product 019635/005	SOLUTION · INJECTION 90MG/10ML (9MG/ML) FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
SODIUM CHLORIDE SODIUM CHLORIDE 0.9%	202832 Product 202832/001	INJECTABLE · INJECTION 9MG/ML (9MG/ML) FDA marketing: Discontinued	2014 DISCONTINUED FINAL	0
SODIUM CHLORIDE SODIUM CHLORIDE 0.9%	202832 Product 202832/002	INJECTABLE · INJECTION 18MG/2ML (9MG/ML) FDA marketing: Discontinued	2014 DISCONTINUED FINAL	0
SODIUM CHLORIDE SODIUM CHLORIDE 0.9%	202832 Product 202832/003	INJECTABLE · INJECTION 22.5MG/2.5ML (9MG/ML) FDA marketing: Discontinued	2014 DISCONTINUED FINAL	0
SODIUM CHLORIDE SODIUM CHLORIDE 0.9%	202832 Product 202832/004	INJECTABLE · INJECTION 27MG/3ML (9MG/ML) FDA marketing: Discontinued	2014 DISCONTINUED FINAL	0
SODIUM CHLORIDE SODIUM CHLORIDE 0.9%	202832 Product 202832/005	INJECTABLE · INJECTION 45MG/5ML (9MG/ML) FDA marketing: Discontinued	2014 DISCONTINUED FINAL	0
SODIUM CHLORIDE SODIUM CHLORIDE 0.9%	202832 Product 202832/006	INJECTABLE · INJECTION 90MG/10ML (9MG/ML) FDA marketing: Prescription	2012 DEEP_REVIEW FINAL	0
SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	018803 Product 018803/004	SOLUTION · INJECTION 18MG/2ML (9MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	018803 Product 018803/005	SOLUTION · INJECTION 27MG/3ML (9MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	018803 Product 018803/006	SOLUTION · INJECTION 45MG/5ML (9MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
SODIUM CHLORIDE SODIUM CHLORIDE 23.4%	018897 Product 018897/003	SOLUTION · INTRAVENOUS 400MEQ/100ML (4MEQ/ML) FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
SODIUM CITRATE CIENBY	219455 Product 219455/001	SOLUTION · EXTRACORPOREAL 40G/L trisodium citrate dihydrate (136MMOL/L citrate) FDA marketing: Prescription	2026 NEW_APPROVAL PROVISIONAL	0
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F 18	022494 Product 022494/001	INJECTABLE · INTRAVENOUS 10-200mCi/ML FDA marketing: Discontinued	2011 EXCLUDED FINAL	0
SODIUM GLYCEROPHOSPHATE GLYCOPHOS	220381 Product 220381/001	SOLUTION · INTRAVENOUS 4.32GM/20ML (216MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
SODIUM GLYCEROPHOSPHATE GLYCOPHOS	220381 Product 220381/002	SOLUTION · INTRAVENOUS 21.6GM/100ML (216MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
SODIUM IODIDE I-131 HICON	021305 Product 021305/007	SOLUTION · ORAL 250-1000mCi FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	0
SODIUM NITRITE SODIUM NITRITE	203922 Product 203922/001	SOLUTION · INTRAVENOUS 300MG/10ML (30MG/ML) FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	2
SODIUM NITRITE; SODIUM THIOSULFATE NITHIODOTE	201444 Product 201444/001	SOLUTION, SOLUTION · INTRAVENOUS, INTRAVENOUS 300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML) FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	8
SODIUM NITROPRUSSIDE NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	209387 Product 209387/001	SOLUTION · INTRAVENOUS 50MG/100ML (0.5MG/ML) FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
SODIUM NITROPRUSSIDE NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	209387 Product 209387/002	SOLUTION · INTRAVENOUS 10MG/50ML (0.2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2017 DEEP_REVIEW PROVISIONAL	0
SODIUM NITROPRUSSIDE NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	209387 Product 209387/003	SOLUTION · INTRAVENOUS 20MG/100ML (0.2MG/ML) FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
SODIUM OXYBATE LUMRYZ	214755 Product 214755/001	FOR SUSPENSION, EXTENDED RELEASE · ORAL 4.5GM/PACKET FDA marketing: Prescription	2030 DEEP_REVIEW FINAL_CHECKING	29
SODIUM OXYBATE LUMRYZ	214755 Product 214755/002	FOR SUSPENSION, EXTENDED RELEASE · ORAL 6GM/PACKET FDA marketing: Prescription	2030 DEEP_REVIEW FINAL_CHECKING	30
SODIUM OXYBATE LUMRYZ	214755 Product 214755/003	FOR SUSPENSION, EXTENDED RELEASE · ORAL 7.5GM/PACKET FDA marketing: Prescription	2030 DEEP_REVIEW FINAL_CHECKING	29
SODIUM OXYBATE LUMRYZ	214755 Product 214755/004	FOR SUSPENSION, EXTENDED RELEASE · ORAL 9GM/PACKET FDA marketing: Prescription	2030 DEEP_REVIEW FINAL_CHECKING	29
SODIUM PHENYLBUTYRATE OLPRUVA	214860 Product 214860/001	FOR SUSPENSION · ORAL 2GM/PACKET FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	3
SODIUM PHENYLBUTYRATE OLPRUVA	214860 Product 214860/002	FOR SUSPENSION · ORAL 3GM/PACKET FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	3
SODIUM PHENYLBUTYRATE OLPRUVA	214860 Product 214860/003	FOR SUSPENSION · ORAL 4GM/PACKET FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	3
SODIUM PHENYLBUTYRATE OLPRUVA	214860 Product 214860/004	FOR SUSPENSION · ORAL 5GM/PACKET FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	3
SODIUM PHENYLBUTYRATE OLPRUVA	214860 Product 214860/005	FOR SUSPENSION · ORAL 6GM/PACKET FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	3
SODIUM PHENYLBUTYRATE OLPRUVA	214860 Product 214860/006	FOR SUSPENSION · ORAL 6.67GM/PACKET FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	3
SODIUM PHENYLBUTYRATE OLPRUVA	214860 Product 214860/007	FOR SUSPENSION · ORAL 0.5GM/PACKET FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	3
SODIUM PHENYLBUTYRATE OLPRUVA	214860 Product 214860/008	FOR SUSPENSION · ORAL 1GM/PACKET FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	3
SODIUM PHENYLBUTYRATE PHEBURANE	216513 Product 216513/001	PELLETS · ORAL 84GM/BOT FDA marketing: Prescription	2003 CANDIDATE FINAL	0
SODIUM PHENYLBUTYRATE; TAURURSODIOL RELYVRIO	216660 Product 216660/001	FOR SUSPENSION · ORAL 3GM/PACKET; 1GM/PACKET FDA marketing: Discontinued	2025 WITHDRAWN FINAL	5
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE SODIUM PHOSPHATES	218274 Product 218274/001	SOLUTION · INTRAVENOUS 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) FDA marketing: Prescription	Master only	0
SODIUM THIOSULFATE PEDMARK	212937 Product 212937/001	SOLUTION · INTRAVENOUS 12.5GM/100ML (125MG/ML) FDA marketing: Prescription	2029 DEEP_REVIEW FINAL_CHECKING	7
SODIUM THIOSULFATE SODIUM THIOSULFATE	203923 Product 203923/001	SOLUTION · INTRAVENOUS 12.5GM/50ML (250MG/ML) FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	6
SODIUM ZIRCONIUM CYCLOSILICATE LOKELMA	207078 Product 207078/001	FOR SUSPENSION · ORAL 5GM/PACKET FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	14
SODIUM ZIRCONIUM CYCLOSILICATE LOKELMA	207078 Product 207078/002	FOR SUSPENSION · ORAL 10GM/PACKET FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	13
SOFOSBUVIR SOVALDI	204671 Product 204671/001	TABLET · ORAL 400MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	9
SOFOSBUVIR SOVALDI	204671 Product 204671/002	TABLET · ORAL 200MG FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	8
SOFOSBUVIR SOVALDI	212480 Product 212480/001	PELLETS · ORAL 150MG/PACKET FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	8
SOFOSBUVIR SOVALDI	212480 Product 212480/002	PELLETS · ORAL 200MG/PACKET FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	8
SOFOSBUVIR; VELPATASVIR EPCLUSA	208341 Product 208341/001	TABLET · ORAL 400MG;100MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	15
SOFOSBUVIR; VELPATASVIR EPCLUSA	208341 Product 208341/002	TABLET · ORAL 200MG;50MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	15
SOFOSBUVIR; VELPATASVIR EPCLUSA	214187 Product 214187/001	PELLETS · ORAL 150MG/PACKET;37.5MG/PACKET FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	14
SOFOSBUVIR; VELPATASVIR EPCLUSA	214187 Product 214187/002	PELLETS · ORAL 200MG/PACKET;50MG/PACKET FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	14
SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR VOSEVI	209195 Product 209195/001	TABLET · ORAL 400MG;100MG;100MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	18
SOFPIRONIUM BROMIDE SOFDRA	217347 Product 217347/001	GEL, METERED · TOPICAL EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	21
SOLIFENACIN SUCCINATE VESICARE LS	209529 Product 209529/001	SUSPENSION · ORAL 1MG/ML FDA marketing: Discontinued	2025 DISCONTINUED FINAL	1
SOLRIAMFETOL HYDROCHLORIDE SOLRIAMFETOL HYDROCHLORIDE	218725 Product 218725/001	TABLET · ORAL EQ 75MG BASE FDA marketing: Prescription	Master only	0
SOLRIAMFETOL HYDROCHLORIDE SOLRIAMFETOL HYDROCHLORIDE	218725 Product 218725/002	TABLET · ORAL EQ 150MG BASE FDA marketing: Prescription	Master only	0
SOLRIAMFETOL HYDROCHLORIDE SUNOSI	211230 Product 211230/001	TABLET · ORAL EQ 75MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	42
SOLRIAMFETOL HYDROCHLORIDE SUNOSI	211230 Product 211230/002	TABLET · ORAL EQ 150MG BASE FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	39
somapacitan-beco Sogroya	761156 Product 761156/001	Injection · Subcutaneous 10MG/1.5ML (6.7MG/ML) Autoinjector FDA marketing: Prescription	2034 CANDIDATE FINAL	0
somatrogon-ghla Ngenla	761184 Product 761184/001	Injection · Subcutaneous 24MG/1.2ML (20MG/ML) Autoinjector FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	1
somatrogon-ghla Ngenla	761184 Product 761184/002	Injection · Subcutaneous 60MG/1.2ML (50MG/ML) Autoinjector FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	1
SONIDEGIB PHOSPHATE ODOMZO	205266 Product 205266/001	CAPSULE · ORAL EQ 200MG BASE FDA marketing: Prescription	Master only	3
SONROTOCLAX BEQALZI	220711 Product 220711/001	TABLET · ORAL 1MG FDA marketing: Prescription	2039 CANDIDATE FINAL	1
SONROTOCLAX BEQALZI	220711 Product 220711/002	TABLET · ORAL 5MG FDA marketing: Prescription	2039 CANDIDATE FINAL	1
SONROTOCLAX BEQALZI	220711 Product 220711/003	TABLET · ORAL 20MG FDA marketing: Prescription	2039 CANDIDATE FINAL	1
SONROTOCLAX BEQALZI	220711 Product 220711/004	TABLET · ORAL 80MG FDA marketing: Prescription	2039 CANDIDATE FINAL	1
SOTAGLIFLOZIN INPEFA	216203 Product 216203/001	TABLET · ORAL 200MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	3
SOTAGLIFLOZIN INPEFA	216203 Product 216203/002	TABLET · ORAL 400MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	3
SOTALOL HYDROCHLORIDE SOTYLIZE	205108 Product 205108/001	SOLUTION · ORAL 5MG/ML (5MG/ML) FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	5
sotatercept-csrk Winrevair	761363 Product 761363/001	For Injection · Subcutaneous 45MG Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	2
sotatercept-csrk Winrevair	761363 Product 761363/002	For Injection · Subcutaneous 60MG Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	2
SOTORASIB LUMAKRAS	214665 Product 214665/001	TABLET · ORAL 120MG FDA marketing: Prescription	2038 DEEP_REVIEW FINAL	6
SOTORASIB LUMAKRAS	214665 Product 214665/002	TABLET · ORAL 320MG FDA marketing: Prescription	2038 DEEP_REVIEW FINAL	6
SOTORASIB LUMAKRAS	214665 Product 214665/003	TABLET · ORAL 240MG FDA marketing: Prescription	2038 DEEP_REVIEW FINAL	6
SPARSENTAN FILSPARI	216403 Product 216403/001	TABLET · ORAL 200MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	3
SPARSENTAN FILSPARI	216403 Product 216403/002	TABLET · ORAL 400MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	3
spesolimab-sbzo Spevigo	761244 Product 761244/001	Injection · Intravenous 450MG/7.5ML (60MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	1
SPINOSAD NATROBA	022408 Product 022408/001	SUSPENSION · TOPICAL 0.9% FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	5
SPIRONOLACTONE CAROSPIR	209478 Product 209478/001	SUSPENSION · ORAL 25MG/5ML FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	8
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION	018801 Product 018801/006	LIQUID · N/A 100% (5.2ML) FDA marketing: Prescription	2023 EXCLUDED FINAL	0
STIRIPENTOL DIACOMIT	206709 Product 206709/001	CAPSULE · ORAL 250MG FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
STIRIPENTOL DIACOMIT	206709 Product 206709/002	CAPSULE · ORAL 500MG FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
STIRIPENTOL DIACOMIT	207223 Product 207223/001	FOR SUSPENSION · ORAL 250MG/PACKET FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
STIRIPENTOL DIACOMIT	207223 Product 207223/002	FOR SUSPENSION · ORAL 500MG/PACKET FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE	215143 Product 215143/001	SOLUTION · INTRAMUSCULAR, INTRAVENOUS 100MG/5ML (20MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	1
SUCRALFATE SUCRALFATE	216758 Product 216758/001	SUSPENSION · ORAL 1GM/10ML FDA marketing: Prescription	Master only	0
SUFENTANIL CITRATE DSUVIA	209128 Product 209128/001	TABLET · SUBLINGUAL EQ 0.03MG BASE FDA marketing: Discontinued	2026 WITHDRAWN FINAL	21
SUGAMMADEX SODIUM BRIDION	022225 Product 022225/001	SOLUTION · INTRAVENOUS EQ 500MG BASE/5ML (EQ 100MG BASE/ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	1
SUGAMMADEX SODIUM BRIDION	022225 Product 022225/002	SOLUTION · INTRAVENOUS EQ 200MG BASE/2ML (EQ 100MG BASE/ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	1
SUGAMMADEX SODIUM SUGAMMADEX SODIUM	215701 Product 215701/001	SOLUTION · INTRAVENOUS EQ 200MG BASE/2ML (EQ 100MG BASE/ML) FDA marketing: Prescription	Master only	0
SUGAMMADEX SODIUM SUGAMMADEX SODIUM	215701 Product 215701/002	SOLUTION · INTRAVENOUS EQ 500MG BASE/5ML (EQ 100MG BASE/ML) FDA marketing: Prescription	Master only	0
SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES LUMASON	203684 Product 203684/001	FOR SUSPENSION · INTRAVENOUS 60.7MG/25MG FDA marketing: Prescription	2014 EXCLUDED FINAL	3
SUMATRIPTAN TOSYMRA	210884 Product 210884/001	SPRAY · NASAL 10MG/SPRAY FDA marketing: Prescription	2031 CANDIDATE FINAL_CHECKING	9
SUMATRIPTAN SUCCINATE ALSUMA (AUTOINJECTOR)	022377 Product 022377/001	SOLUTION · SUBCUTANEOUS EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) FDA marketing: WITHDRAWN	2017 WITHDRAWN FINAL	1
SUMATRIPTAN SUCCINATE ONZETRA XSAIL	206099 Product 206099/001	POWDER · NASAL EQ 11MG BASE FDA marketing: Discontinued	2026 DISCONTINUED FINAL	12
SUMATRIPTAN SUCCINATE SUMAVEL DOSEPRO	022239 Product 022239/002	SOLUTION · SUBCUTANEOUS EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) FDA marketing: DISCONTINUED	2016 DISCONTINUED FINAL	0
SUMATRIPTAN SUCCINATE ZECUITY	202278 Product 202278/001	SYSTEM · IONTOPHORESIS EQ 6.5MG BASE/4HR FDA marketing: Discontinued	2017 DISCONTINUED FINAL	9
SUMATRIPTAN SUCCINATE ZEMBRACE SYMTOUCH (AUTOINJECTOR)	208223 Product 208223/001	SOLUTION · SUBCUTANEOUS EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) FDA marketing: Prescription	2016 DEEP_REVIEW FINAL_CHECKING	3
SUNVOZERTINIB ZEGFROVY	219839 Product 219839/001	TABLET · ORAL 150MG FDA marketing: Prescription	2039 CANDIDATE FINAL	3
SUNVOZERTINIB ZEGFROVY	219839 Product 219839/002	TABLET · ORAL 200MG FDA marketing: Prescription	2039 CANDIDATE FINAL	3
sutimlimab-jome Enjaymo	761164 Product 761164/001	Injection · Intravenous 1,100MG/22ML (50MG/ML) Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	2
SUVOREXANT BELSOMRA	204569 Product 204569/001	TABLET · ORAL 5MG FDA marketing: Prescription	Master only	4
SUVOREXANT BELSOMRA	204569 Product 204569/002	TABLET · ORAL 10MG FDA marketing: Prescription	Master only	4
SUVOREXANT BELSOMRA	204569 Product 204569/003	TABLET · ORAL 15MG FDA marketing: Prescription	Master only	4
SUVOREXANT BELSOMRA	204569 Product 204569/004	TABLET · ORAL 20MG FDA marketing: Prescription	Master only	4
SUZETRIGINE JOURNAVX	219209 Product 219209/001	TABLET · ORAL 50MG FDA marketing: Prescription	2040 CANDIDATE FINAL	1
TACROLIMUS ASTAGRAF XL	204096 Product 204096/001	CAPSULE, EXTENDED RELEASE · ORAL EQ 0.5MG BASE FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
TACROLIMUS ASTAGRAF XL	204096 Product 204096/002	CAPSULE, EXTENDED RELEASE · ORAL EQ 1MG BASE FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
TACROLIMUS ASTAGRAF XL	204096 Product 204096/003	CAPSULE, EXTENDED RELEASE · ORAL EQ 5MG BASE FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
TACROLIMUS ENVARSUS XR	206406 Product 206406/001	TABLET, EXTENDED RELEASE · ORAL EQ 0.75MG BASE FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	10
TACROLIMUS ENVARSUS XR	206406 Product 206406/002	TABLET, EXTENDED RELEASE · ORAL EQ 1MG BASE FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	10
TACROLIMUS ENVARSUS XR	206406 Product 206406/003	TABLET, EXTENDED RELEASE · ORAL EQ 4MG BASE FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	10
TACROLIMUS PROGRAF	210115 Product 210115/001	FOR SUSPENSION · ORAL EQ 0.2MG BASE/PACKET FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
TACROLIMUS PROGRAF	210115 Product 210115/002	FOR SUSPENSION · ORAL EQ 1MG BASE/PACKET FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
TADALAFIL CHEWTADZY	218527 Product 218527/001	TABLET, CHEWABLE · ORAL 5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	1
TADALAFIL CHEWTADZY	218527 Product 218527/002	TABLET, CHEWABLE · ORAL 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	1
TADALAFIL CHEWTADZY	218527 Product 218527/003	TABLET, CHEWABLE · ORAL 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2024 DISQUALIFIED FINAL	1
TADALAFIL TADLIQ	214522 Product 214522/001	SUSPENSION · ORAL 20MG/5ML FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	9
TAFAMIDIS VYNDAMAX	212161 Product 212161/001	CAPSULE · ORAL 61MG FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	3
TAFAMIDIS MEGLUMINE VYNDAQEL	211996 Product 211996/001	CAPSULE · ORAL 20MG FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	2
tafasitamab-cxix Monjuvi	761163 Product 761163/001	For Injection · Intravenous 200MG Single-Dose Vial FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	0
TAFENOQUINE SUCCINATE ARAKODA	210607 Product 210607/001	TABLET · ORAL EQ 100MG BASE FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	4
TAFENOQUINE SUCCINATE KRINTAFEL	210795 Product 210795/001	TABLET · ORAL EQ 150MG BASE FDA marketing: Prescription	2025 DEEP_REVIEW PROVISIONAL	0
TAFLUPROST ZIOPTAN	202514 Product 202514/001	SOLUTION/DROPS · OPHTHALMIC 0.0015% FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	2
tagraxofusp-erzs Elzonris	761116 Product 761116/001	Injection · Intravenous 1,000MCG/1ML Single-Dose Vial FDA marketing: Prescription	2030 CANDIDATE FINAL	0
TALAZOPARIB TOSYLATE TALZENNA	211651 Product 211651/001	CAPSULE · ORAL EQ 0.25MG BASE FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	6
TALAZOPARIB TOSYLATE TALZENNA	211651 Product 211651/002	CAPSULE · ORAL EQ 1MG BASE FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	5
TALAZOPARIB TOSYLATE TALZENNA	211651 Product 211651/003	CAPSULE · ORAL EQ 0.5MG BASE FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	6
TALAZOPARIB TOSYLATE TALZENNA	211651 Product 211651/004	CAPSULE · ORAL EQ 0.75MG BASE FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	5
TALAZOPARIB TOSYLATE TALZENNA	211651 Product 211651/005	CAPSULE · ORAL EQ 0.1MG BASE FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	6
TALAZOPARIB TOSYLATE TALZENNA	211651 Product 211651/006	CAPSULE · ORAL EQ 0.35MG BASE FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	6
TALAZOPARIB TOSYLATE TALZENNA	217439 Product 217439/001	CAPSULE · ORAL EQ 0.1MG BASE FDA marketing: Prescription	2032 CANDIDATE FINAL	6
TALAZOPARIB TOSYLATE TALZENNA	217439 Product 217439/002	CAPSULE · ORAL EQ 0.25MG BASE FDA marketing: Prescription	2032 CANDIDATE FINAL	6
TALAZOPARIB TOSYLATE TALZENNA	217439 Product 217439/003	CAPSULE · ORAL EQ 0.35MG BASE FDA marketing: Prescription	2032 CANDIDATE FINAL	6
TALAZOPARIB TOSYLATE TALZENNA	217439 Product 217439/004	CAPSULE · ORAL EQ 0.5MG BASE FDA marketing: Prescription	2032 CANDIDATE FINAL	6
TALAZOPARIB TOSYLATE TALZENNA	217439 Product 217439/005	CAPSULE · ORAL EQ 0.75MG BASE FDA marketing: Prescription	2032 CANDIDATE FINAL	6
TALAZOPARIB TOSYLATE TALZENNA	217439 Product 217439/006	CAPSULE · ORAL EQ 1MG BASE FDA marketing: Prescription	2032 CANDIDATE FINAL	6
TALC STERITALC	205555 Product 205555/001	POWDER · INTRAPLEURAL 2GM/VIAL FDA marketing: Prescription	2017 DEEP_REVIEW PROVISIONAL	0
TALC STERITALC	205555 Product 205555/002	POWDER · INTRAPLEURAL 3GM/VIAL FDA marketing: Prescription	2017 DEEP_REVIEW PROVISIONAL	0
TALC STERITALC	205555 Product 205555/003	POWDER · INTRAPLEURAL 4GM/VIAL FDA marketing: Prescription	2017 DEEP_REVIEW PROVISIONAL	0
TALETRECTINIB ADIPATE IBTROZI	219713 Product 219713/001	CAPSULE · ORAL EQ 200MG BASE FDA marketing: Prescription	2033 CANDIDATE FINAL	2
taliglucerase alfa Elelyso	022458 Product 022458/001	For Injection · Intravenous 200UNITS Single-Dose Vial FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
talquetamab-tgvs Talvey	761342 Product 761342/001	Injection · Subcutaneous 3MG/1.5ML (2MG/ML) Single-Dose Vial FDA marketing: Prescription	2037 CANDIDATE FINAL_CHECKING	1
talquetamab-tgvs Talvey	761342 Product 761342/002	Injection · Subcutaneous 40MG/ML Single-Dose Vial FDA marketing: Prescription	2037 CANDIDATE FINAL_CHECKING	1
TAPENTADOL HYDROCHLORIDE NUCYNTA	203794 Product 203794/001	SOLUTION · ORAL EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2026 DISQUALIFIED FINAL	0
TAPENTADOL HYDROCHLORIDE NUCYNTA ER	200533 Product 200533/001	TABLET, EXTENDED RELEASE · ORAL EQ 50MG BASE FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	2
TAPENTADOL HYDROCHLORIDE NUCYNTA ER	200533 Product 200533/002	TABLET, EXTENDED RELEASE · ORAL EQ 100MG BASE FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	2
TAPENTADOL HYDROCHLORIDE NUCYNTA ER	200533 Product 200533/003	TABLET, EXTENDED RELEASE · ORAL EQ 150MG BASE FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	2
TAPENTADOL HYDROCHLORIDE NUCYNTA ER	200533 Product 200533/004	TABLET, EXTENDED RELEASE · ORAL EQ 200MG BASE FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	2
TAPENTADOL HYDROCHLORIDE NUCYNTA ER	200533 Product 200533/005	TABLET, EXTENDED RELEASE · ORAL EQ 250MG BASE FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	2
TAPINAROF VTAMA	215272 Product 215272/001	CREAM · TOPICAL 1% FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	12
tarlatamab-dlle Imdelltra	761344 Product 761344/001	Injection · Intravenous 1MG Single-Dose Vial FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	1
tarlatamab-dlle Imdelltra	761344 Product 761344/002	Injection · Intravenous 10MG Single-Dose Vial FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	1
TASIMELTEON HETLIOZ	205677 Product 205677/001	CAPSULE · ORAL 20MG FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	31
TASIMELTEON HETLIOZ LQ	214517 Product 214517/001	SUSPENSION · ORAL 4MG/ML FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	27
TAVABOROLE KERYDIN	204427 Product 204427/001	SOLUTION · TOPICAL 5% FDA marketing: Discontinued	2024 WITHDRAWN FINAL	6
TAVAPADON JUVMO	220415 Product 220415/001	TABLET · ORAL 0.25MG FDA marketing: Prescription	2034 CANDIDATE FINAL	1
TAVAPADON JUVMO	220415 Product 220415/002	TABLET · ORAL 1MG FDA marketing: Prescription	2034 CANDIDATE FINAL	1
TAVAPADON JUVMO	220415 Product 220415/003	TABLET · ORAL 5MG FDA marketing: Prescription	2034 CANDIDATE FINAL	1
TAVAPADON JUVMO	220415 Product 220415/004	TABLET · ORAL 10MG FDA marketing: Prescription	2034 CANDIDATE FINAL	1
TAVAPADON JUVMO	220415 Product 220415/005	TABLET · ORAL 15MG FDA marketing: Prescription	2034 CANDIDATE FINAL	1
TAZAROTENE ARAZLO	211882 Product 211882/001	LOTION · TOPICAL 0.045% FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	3
TAZAROTENE FABIOR	202428 Product 202428/001	AEROSOL, FOAM · TOPICAL 0.1% FDA marketing: Prescription	2015 DEEP_REVIEW FINAL	3
TAZEMETOSTAT HYDROBROMIDE TAZVERIK	211723 Product 211723/001	TABLET · ORAL EQ 200MG BASE FDA marketing: DISCONTINUED	2026 DISQUALIFIED FINAL	27
tbo-filgrastim Granix	125294 Product 125294/001	Injection · Subcutaneous 300MCG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2024 CANDIDATE FINAL	0
tbo-filgrastim Granix	125294 Product 125294/002	Injection · Subcutaneous 480MCG/0.8ML Pre-Filled Syringe FDA marketing: Prescription	2024 CANDIDATE FINAL	0
tebentafusp-tebn Kimmtrak	761228 Product 761228/001	Injection · Intravenous 100MCG/0.5ML Single-Dose Vial FDA marketing: Prescription	2034 CANDIDATE FINAL_CHECKING	1
TEBIPENEM PIVOXIL HYDROBROMIDE UTEBZI	215960 Product 215960/001	TABLET · ORAL EQ 300MG BASE FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	2
TECHNETIUM TC-99M EXAMETAZIME KIT DRAX EXAMETAZIME	208870 Product 208870/001	POWDER · INTRAVENOUS N/A FDA marketing: Prescription	2017 EXCLUDED PROVISIONAL	0
TECHNETIUM TC-99M LABELED CARBON TECHNEGAS KIT	022335 Product 022335/001	AEROSOL · INHALATION N/A FDA marketing: Prescription	2023 EXCLUDED FINAL	1
TECHNETIUM TC-99M MERTIATIDE KIT TECHNETIUM TC 99M MERTIATIDE KIT	216820 Product 216820/001	POWDER · INTRAVENOUS N/A FDA marketing: Prescription	2023 EXCLUDED FINAL	0
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR DRYTEC	017693 Product 017693/002	SOLUTION · INTRAVENOUS, ORAL 68-2703mCi/GENERATOR FDA marketing: Discontinued	2013 EXCLUDED FINAL	0
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR RADIOGENIX SYSTEM	202158 Product 202158/001	SOLUTION · INTRAVENOUS, INTRAVESICULAR, OPHTHALMIC 30-1153mCi/GENERATOR FDA marketing: Discontinued	2018 EXCLUDED PROVISIONAL	0
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR TECHNELITE	017771 Product 017771/002	SOLUTION · INTRAVENOUS 1-20 CI/GENERATOR FDA marketing: Prescription	2014 EXCLUDED FINAL	0
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR ULTRA-TECHNEKOW V4	017243 Product 017243/003	SOLUTION · INTRAVENOUS 1-19 CI/GENERATOR FDA marketing: Prescription	2014 EXCLUDED FINAL	0
TECHNETIUM TC-99M SUCCIMER NEPHROSCAN	214993 Product 214993/001	POWDER · INTRAVENOUS N/A FDA marketing: Prescription	2022 EXCLUDED FINAL	0
TECHNETIUM TC-99M TILMANOCEPT LYMPHOSEEK KIT	202207 Product 202207/001	INJECTABLE · INJECTION N/A FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	1
teclistamab-cqyv Tecvayli	761291 Product 761291/001	Injection · Subcutaneous 30MG/3ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	1
teclistamab-cqyv Tecvayli	761291 Product 761291/002	Injection · Subcutaneous 153MG/1.7ML (90MG/ML) Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	1
TECOVIRIMAT TPOXX	208627 Product 208627/001	CAPSULE · ORAL 200MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	5
TECOVIRIMAT TPOXX	214518 Product 214518/001	SOLUTION · INTRAVENOUS 200MG/20ML (10MG/ML) FDA marketing: Prescription	2031 CANDIDATE FINAL_CHECKING	5
TEDIZOLID PHOSPHATE SIVEXTRO	205435 Product 205435/001	TABLET · ORAL 200MG FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	7
TEDIZOLID PHOSPHATE SIVEXTRO	205436 Product 205436/001	POWDER · INTRAVENOUS 200MG/VIAL FDA marketing: Prescription	2028 DEEP_REVIEW FINAL	7
TEDUGLUTIDE GATTEX KIT	203441 Product 203441/001	POWDER · SUBCUTANEOUS 5MG/VIAL FDA marketing: Prescription	2026 CANDIDATE FINAL	2
TELAPREVIR INCIVEK	201917 Product 201917/001	TABLET · ORAL 375MG FDA marketing: Discontinued	2015 DISCONTINUED FINAL	1
TELAVANCIN VIBATIV	022110 Product 022110/001	POWDER · INTRAVENOUS EQ 250MG BASE/VIAL FDA marketing: DISCONTINUED	2017 DISQUALIFIED FINAL	1
TELAVANCIN VIBATIV	022110 Product 022110/002	POWDER · INTRAVENOUS EQ 750MG BASE/VIAL FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
telisotuzumab vedotin-tllv Emrelis	761384 Product 761384/001	For Injection · Intravenous 20MG Single-Dose Vial FDA marketing: Prescription	2037 CANDIDATE FINAL_CHECKING	1
telisotuzumab vedotin-tllv Emrelis	761384 Product 761384/002	For Injection · Intravenous 100MG Single-Dose Vial FDA marketing: Prescription	2037 CANDIDATE FINAL_CHECKING	1
TELOTRISTAT ETIPRATE XERMELO	208794 Product 208794/001	TABLET · ORAL EQ 250MG BASE FDA marketing: Prescription	2031 CANDIDATE FINAL	5
TENAPANOR HYDROCHLORIDE IBSRELA	211801 Product 211801/001	TABLET · ORAL EQ 50MG BASE FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	6
TENAPANOR HYDROCHLORIDE XPHOZAH	213931 Product 213931/001	TABLET · ORAL EQ 10MG BASE FDA marketing: DISCONTINUED	2024 DISQUALIFIED FINAL	6
TENAPANOR HYDROCHLORIDE XPHOZAH	213931 Product 213931/002	TABLET · ORAL EQ 20MG BASE FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	6
TENAPANOR HYDROCHLORIDE XPHOZAH	213931 Product 213931/003	TABLET · ORAL EQ 30MG BASE FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	6
TENOFOVIR ALAFENAMIDE FUMARATE VEMLIDY	208464 Product 208464/001	TABLET · ORAL EQ 25MG BASE FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	2
TENOFOVIR DISOPROXIL FUMARATE VIREAD	021356 Product 021356/002	TABLET · ORAL 150MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
TENOFOVIR DISOPROXIL FUMARATE VIREAD	021356 Product 021356/003	TABLET · ORAL 200MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
TENOFOVIR DISOPROXIL FUMARATE VIREAD	021356 Product 021356/004	TABLET · ORAL 250MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	0
TENOFOVIR DISOPROXIL FUMARATE VIREAD	022577 Product 022577/001	POWDER · ORAL 40MG/SCOOPFUL FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	4
teplizumab-mzwv Tzield	761183 Product 761183/001	Injection · Intravenous 2MG/2ML (1MG/ML) Single-Dose Vial FDA marketing: Prescription	2034 DEEP_REVIEW FINAL_CHECKING	2
TEPOTINIB HYDROCHLORIDE TEPMETKO	214096 Product 214096/001	TABLET · ORAL EQ 225MG BASE FDA marketing: Prescription	2030 CANDIDATE FINAL	8
teprotumumab-trbw Tepezza	761143 Product 761143/001	For Injection · Intravenous 500MG Single-Dose Vial FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	0
TERAZOSIN HYDROCHLORIDE TEZRULY	218139 Product 218139/001	SOLUTION · ORAL EQ 1MG BASE/ML FDA marketing: Discontinued	2025 DISCONTINUED FINAL	2
TERIFLUNOMIDE AUBAGIO	202992 Product 202992/001	TABLET · ORAL 7MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	3
TERIFLUNOMIDE AUBAGIO	202992 Product 202992/002	TABLET · ORAL 14MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	3
TERIPARATIDE BONSITY	211939 Product 211939/001	SOLUTION · SUBCUTANEOUS 0.56MG/2.24ML (0.25MG/ML) FDA marketing: Prescription	2019 EXCLUDED FINAL	0
TERIPARATIDE TERIPARATIDE	218771 Product 218771/001	SOLUTION · SUBCUTANEOUS 0.56MG/2.24ML (0.25MG/ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
TERLIPRESSIN ACETATE TERLIVAZ	022231 Product 022231/001	POWDER · INTRAVENOUS EQ 0.85MG BASE/VIAL FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	1
tesamorelin Egrifta	022505 Product 022505/001	For Injection · Subcutaneous 1MG Single-Dose Vial FDA marketing: Prescription	2020 DISCONTINUED FINAL	0
tesamorelin Egrifta SV	022505 Product 022505/002	For Injection · Subcutaneous 2MG Single-Dose Vial FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	0
TESTOSTERONE ANDRODERM	020489 Product 020489/003	FILM, EXTENDED RELEASE · TRANSDERMAL 2MG/24HR FDA marketing: Discontinued	2025 WITHDRAWN FINAL	0
TESTOSTERONE ANDRODERM	020489 Product 020489/004	FILM, EXTENDED RELEASE · TRANSDERMAL 4MG/24HR FDA marketing: Discontinued	2025 WITHDRAWN FINAL	0
TESTOSTERONE ANDROGEL	022309 Product 022309/001	GEL, METERED · TRANSDERMAL 1.62% (20.25MG/1.25GM ACTUATION) FDA marketing: Prescription	2015 EXISTING_GENERIC DISQUALIFIED	8
TESTOSTERONE ANDROGEL	022309 Product 022309/002	GEL · TRANSDERMAL 1.62% (20.25MG/1.25GM PACKET) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	8
TESTOSTERONE ANDROGEL	022309 Product 022309/003	GEL · TRANSDERMAL 1.62% (40.5MG/2.5GM PACKET) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	8
TESTOSTERONE AXIRON	022504 Product 022504/001	SOLUTION, METERED · TRANSDERMAL 30MG/1.5ML ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2017 DISCONTINUED FINAL	6
TESTOSTERONE FORTESTA	021463 Product 021463/001	GEL, METERED · TRANSDERMAL 10MG/0.5GM ACTUATION FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	2
TESTOSTERONE NATESTO	205488 Product 205488/001	GEL, METERED · NASAL 5.5MG/0.122GM ACTUATION FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	2
TESTOSTERONE TESTOSTERONE	202763 Product 202763/001	GEL · TRANSDERMAL 25MG/2.5GM PACKET FDA marketing: Withdrawn	2018 WITHDRAWN FINAL	0
TESTOSTERONE TESTOSTERONE	202763 Product 202763/002	GEL · TRANSDERMAL 50MG/5GM PACKET FDA marketing: Withdrawn	2018 WITHDRAWN FINAL	0
TESTOSTERONE TESTOSTERONE	203098 Product 203098/001	GEL, METERED · TRANSDERMAL 12.5MG/1.25GM ACTUATION FDA marketing: Withdrawn	2018 WITHDRAWN FINAL	0
TESTOSTERONE TESTOSTERONE	203098 Product 203098/002	GEL · TRANSDERMAL 25MG/2.5GM PACKET FDA marketing: Withdrawn	2018 WITHDRAWN FINAL	0
TESTOSTERONE TESTOSTERONE	203098 Product 203098/003	GEL · TRANSDERMAL 50MG/5GM PACKET FDA marketing: Withdrawn	2018 WITHDRAWN FINAL	0
TESTOSTERONE VOGELXO	204399 Product 204399/002	GEL · TRANSDERMAL 50MG/5GM PACKET FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	3
TESTOSTERONE VOGELXO	204399 Product 204399/003	GEL, METERED · TRANSDERMAL 12.5MG/1.25GM ACTUATION FDA marketing: Prescription	2014 DEEP_REVIEW FINAL	3
TESTOSTERONE CYPIONATE AZMIRO	216318 Product 216318/001	SOLUTION · INTRAMUSCULAR 200MG/ML (200MG/ML) FDA marketing: Discontinued	2026 DISCONTINUED FINAL	3
TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR)	209863 Product 209863/001	SOLUTION · SUBCUTANEOUS 50MG/0.5ML (50MG/0.5ML) FDA marketing: Prescription	2035 DEEP_REVIEW FINAL_CHECKING	23
TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR)	209863 Product 209863/002	SOLUTION · SUBCUTANEOUS 75MG/0.5ML (75MG/0.5ML) FDA marketing: Prescription	2035 DEEP_REVIEW FINAL_CHECKING	23
TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR)	209863 Product 209863/003	SOLUTION · SUBCUTANEOUS 100MG/0.5ML (100MG/0.5ML) FDA marketing: Prescription	2035 DEEP_REVIEW FINAL_CHECKING	23
TESTOSTERONE UNDECANOATE AVEED	022219 Product 022219/001	INJECTABLE · INTRAMUSCULAR 750MG/3ML (250MG/ML) FDA marketing: RX	2017 DEEP_REVIEW FINAL	2
TESTOSTERONE UNDECANOATE JATENZO	206089 Product 206089/001	CAPSULE · ORAL 158MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	11
TESTOSTERONE UNDECANOATE JATENZO	206089 Product 206089/002	CAPSULE · ORAL 198MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	11
TESTOSTERONE UNDECANOATE JATENZO	206089 Product 206089/003	CAPSULE · ORAL 237MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	11
TESTOSTERONE UNDECANOATE KYZATREX	213953 Product 213953/001	CAPSULE · ORAL 100MG FDA marketing: Discontinued	2025 DISCONTINUED FINAL	6
TESTOSTERONE UNDECANOATE KYZATREX	213953 Product 213953/002	CAPSULE · ORAL 150MG FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	6
TESTOSTERONE UNDECANOATE KYZATREX	213953 Product 213953/003	CAPSULE · ORAL 200MG FDA marketing: Prescription	2025 DEEP_REVIEW FINAL_CHECKING	6
TESTOSTERONE UNDECANOATE KYZATREX	213953 Product 213953/004	CAPSULE · ORAL 50MG FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
TESTOSTERONE UNDECANOATE TLANDO	208088 Product 208088/001	CAPSULE · ORAL 112.5MG FDA marketing: Prescription	2041 CANDIDATE FINAL_CHECKING	15
TETRACAINE HYDROCHLORIDE TETRACAINE HYDROCHLORIDE	208135 Product 208135/001	SOLUTION · OPHTHALMIC 0.5% FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	0
TETRACAINE HYDROCHLORIDE TETRACAINE HYDROCHLORIDE	210821 Product 210821/001	SOLUTION · OPHTHALMIC 0.5% FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	0
tezepelumab-ekko Tezspire	761224 Product 761224/001	Injection · Subcutaneous 210MG/1.91ML (110MG/ML) Single-Dose Vial FDA marketing: Prescription	2034 CANDIDATE FINAL_CHECKING	2
THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE	213131 Product 213131/001	INJECTABLE · INJECTION 100MG/ML FDA marketing: Prescription	Master only	0
THIOTEPA TEPADINA	208264 Product 208264/001	POWDER · INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 15MG/VIAL FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	0
THIOTEPA TEPADINA	208264 Product 208264/002	POWDER · INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 100MG/VIAL FDA marketing: Prescription	2020 EXISTING_GENERIC DISQUALIFIED	0
THIOTEPA TEPADINA AND SODIUM CHLORIDE	208264 Product 208264/003	POWDER · INTRAVENOUS 200MG FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	1
THIOTEPA TEPADINA AND SODIUM CHLORIDE	208264 Product 208264/004	POWDER · INTRAVENOUS 400MG FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	1
THIOTEPA TEPYLUTE	216984 Product 216984/001	SOLUTION · INTRAVENOUS 15MG/1.5ML (10MG/ML) FDA marketing: Discontinued	2026 DISCONTINUED FINAL	2
THIOTEPA TEPYLUTE	216984 Product 216984/002	SOLUTION · INTRAVENOUS 100MG/10ML (10MG/ML) FDA marketing: Discontinued	2026 DISCONTINUED FINAL	2
TICAGRELOR BRILINTA	022433 Product 022433/001	TABLET · ORAL 90MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	2
TICAGRELOR BRILINTA	022433 Product 022433/002	TABLET · ORAL 60MG FDA marketing: Prescription	2018 EXISTING_GENERIC DISQUALIFIED	2
TIGECYCLINE TIGECYCLINE	205645 Product 205645/001	POWDER · INTRAVENOUS 50MG/VIAL FDA marketing: Discontinued	DISCONTINUED FINAL	0
TIGECYCLINE TIGECYCLINE	208744 Product 208744/001	POWDER · INTRAVENOUS 50MG/VIAL FDA marketing: Discontinued	DISCONTINUED FINAL	0
TIGECYCLINE TIGECYCLINE	211158 Product 211158/001	POWDER · INTRAVENOUS 50MG/VIAL FDA marketing: Prescription	2015 EXISTING_GENERIC DISQUALIFIED	1
tildrakizumab-asmn Ilumya	761067 Product 761067/001	Injection · Subcutaneous 100MG/ML Pre-Filled Syringe FDA marketing: Prescription	2031 CANDIDATE FINAL	0
TIOPRONIN THIOLA EC	211843 Product 211843/001	TABLET, DELAYED RELEASE · ORAL 100MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	1
TIOPRONIN THIOLA EC	211843 Product 211843/002	TABLET, DELAYED RELEASE · ORAL 300MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	1
TIOPRONIN TIOCYSTIN	212927 Product 212927/001	TABLET · ORAL 100MG FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
TIOPRONIN TIOCYSTIN	212927 Product 212927/002	TABLET · ORAL 200MG FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	0
TIOTROPIUM BROMIDE SPIRIVA RESPIMAT	021936 Product 021936/001	SPRAY, METERED · INHALATION EQ 0.0025MG BASE/INH FDA marketing: Prescription	2018 DEEP_REVIEW FINAL	4
TIOTROPIUM BROMIDE SPIRIVA RESPIMAT	021936 Product 021936/002	SPRAY, METERED · INHALATION EQ 0.00125MG BASE/INH FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	18
TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE LONSURF	207981 Product 207981/001	TABLET · ORAL EQ 6.14MG BASE;15MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	7
TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE LONSURF	207981 Product 207981/002	TABLET · ORAL EQ 8.19MG BASE;20MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	7
TIRATRICOL EMCITATE	220963 Product 220963/001	TABLET · ORAL 350MCG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	1
TIRBANIBULIN KLISYRI	213189 Product 213189/001	OINTMENT · TOPICAL 1% FDA marketing: Prescription	2038 DEEP_REVIEW FINAL	7
TIROFIBAN HYDROCHLORIDE AGGRASTAT	020912 Product 020912/002	SOLUTION · INJECTION EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	6
TIRZEPATIDE MOUNJARO	215866 Product 215866/007	SOLUTION · SUBCUTANEOUS 2.5MG/0.5ML (2.5MG/0.5ML) FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	8
TIRZEPATIDE MOUNJARO	215866 Product 215866/008	SOLUTION · SUBCUTANEOUS 5MG/0.5ML (5MG/0.5ML) FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	8
TIRZEPATIDE MOUNJARO	215866 Product 215866/009	SOLUTION · SUBCUTANEOUS 7.5MG/0.5ML (7.5MG/0.5ML) FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	8
TIRZEPATIDE MOUNJARO	215866 Product 215866/010	SOLUTION · SUBCUTANEOUS 10MG/0.5ML (10MG/0.5ML) FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	8
TIRZEPATIDE MOUNJARO	215866 Product 215866/011	SOLUTION · SUBCUTANEOUS 12.5MG/0.5ML (12.5MG/0.5ML) FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	8
TIRZEPATIDE MOUNJARO	215866 Product 215866/012	SOLUTION · SUBCUTANEOUS 15MG/0.5ML (15MG/0.5ML) FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	8
TIRZEPATIDE MOUNJARO	215866 Product 215866/013	SOLUTION · SUBCUTANEOUS 10MG/2.4ML (4.17MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE MOUNJARO	215866 Product 215866/014	SOLUTION · SUBCUTANEOUS 20MG/2.4ML (8.33MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE MOUNJARO	215866 Product 215866/015	SOLUTION · SUBCUTANEOUS 30MG/2.4ML (12.5MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE MOUNJARO	215866 Product 215866/016	SOLUTION · SUBCUTANEOUS 40MG/2.4ML (16.7MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE MOUNJARO	215866 Product 215866/017	SOLUTION · SUBCUTANEOUS 50MG/2.4ML (20.8MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE MOUNJARO	215866 Product 215866/018	SOLUTION · SUBCUTANEOUS 60MG/2.4ML (25MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE MOUNJARO (AUTOINJECTOR)	215866 Product 215866/001	SOLUTION · SUBCUTANEOUS 2.5MG/0.5ML (2.5MG/0.5ML) FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	8
TIRZEPATIDE MOUNJARO (AUTOINJECTOR)	215866 Product 215866/002	SOLUTION · SUBCUTANEOUS 5MG/0.5ML (5MG/0.5ML) FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	8
TIRZEPATIDE MOUNJARO (AUTOINJECTOR)	215866 Product 215866/003	SOLUTION · SUBCUTANEOUS 7.5MG/0.5ML (7.5MG/0.5ML) FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	8
TIRZEPATIDE MOUNJARO (AUTOINJECTOR)	215866 Product 215866/004	SOLUTION · SUBCUTANEOUS 10MG/0.5ML (10MG/0.5ML) FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	8
TIRZEPATIDE MOUNJARO (AUTOINJECTOR)	215866 Product 215866/005	SOLUTION · SUBCUTANEOUS 12.5MG/0.5ML (12.5MG/0.5ML) FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	8
TIRZEPATIDE MOUNJARO (AUTOINJECTOR)	215866 Product 215866/006	SOLUTION · SUBCUTANEOUS 15MG/0.5ML (15MG/0.5ML) FDA marketing: Prescription	2039 DEEP_REVIEW FINAL	8
TIRZEPATIDE MOUNJARO KWIKPEN	215866 Product 215866/019	SOLUTION · SUBCUTANEOUS 10MG/2.4ML (4.17MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE MOUNJARO KWIKPEN	215866 Product 215866/020	SOLUTION · SUBCUTANEOUS 20MG/2.4ML (8.33MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE MOUNJARO KWIKPEN	215866 Product 215866/021	SOLUTION · SUBCUTANEOUS 30MG/2.4ML (12.5MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE MOUNJARO KWIKPEN	215866 Product 215866/022	SOLUTION · SUBCUTANEOUS 40MG/2.4ML (16.7MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE MOUNJARO KWIKPEN	215866 Product 215866/023	SOLUTION · SUBCUTANEOUS 50MG/2.4ML (20.8MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE MOUNJARO KWIKPEN	215866 Product 215866/024	SOLUTION · SUBCUTANEOUS 60MG/2.4ML (25MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE ZEPBOUND	217806 Product 217806/007	SOLUTION · SUBCUTANEOUS 2.5MG/0.5ML (2.5MG/0.5ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	8
TIRZEPATIDE ZEPBOUND	217806 Product 217806/008	SOLUTION · SUBCUTANEOUS 5MG/0.5ML (5MG/0.5ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	8
TIRZEPATIDE ZEPBOUND	217806 Product 217806/009	SOLUTION · SUBCUTANEOUS 7.5MG/0.5ML (7.5MG/0.5ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	8
TIRZEPATIDE ZEPBOUND	217806 Product 217806/010	SOLUTION · SUBCUTANEOUS 10MG/0.5ML (10MG/0.5ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	8
TIRZEPATIDE ZEPBOUND	217806 Product 217806/011	SOLUTION · SUBCUTANEOUS 12.5MG/0.5ML (12.5MG/0.5ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	8
TIRZEPATIDE ZEPBOUND	217806 Product 217806/012	SOLUTION · SUBCUTANEOUS 15MG/0.5ML (15MG/0.5ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	8
TIRZEPATIDE ZEPBOUND	217806 Product 217806/013	SOLUTION · SUBCUTANEOUS 10MG/2.4ML (4.17MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE ZEPBOUND	217806 Product 217806/014	SOLUTION · SUBCUTANEOUS 20MG/2.4ML (8.33MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE ZEPBOUND	217806 Product 217806/015	SOLUTION · SUBCUTANEOUS 30MG/2.4ML (12.5MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE ZEPBOUND	217806 Product 217806/016	SOLUTION · SUBCUTANEOUS 40MG/2.4ML (16.7MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE ZEPBOUND	217806 Product 217806/017	SOLUTION · SUBCUTANEOUS 50MG/2.4ML (20.8MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE ZEPBOUND	217806 Product 217806/018	SOLUTION · SUBCUTANEOUS 60MG/2.4ML (25MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE ZEPBOUND (AUTOINJECTOR)	217806 Product 217806/001	SOLUTION · SUBCUTANEOUS 2.5MG/0.5ML (2.5MG/0.5ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	8
TIRZEPATIDE ZEPBOUND (AUTOINJECTOR)	217806 Product 217806/002	SOLUTION · SUBCUTANEOUS 5MG/0.5ML (5MG/0.5ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	8
TIRZEPATIDE ZEPBOUND (AUTOINJECTOR)	217806 Product 217806/003	SOLUTION · SUBCUTANEOUS 7.5MG/0.5ML (7.5MG/0.5ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	8
TIRZEPATIDE ZEPBOUND (AUTOINJECTOR)	217806 Product 217806/004	SOLUTION · SUBCUTANEOUS 10MG/0.5ML (10MG/0.5ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	8
TIRZEPATIDE ZEPBOUND (AUTOINJECTOR)	217806 Product 217806/005	SOLUTION · SUBCUTANEOUS 12.5MG/0.5ML (12.5MG/0.5ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	8
TIRZEPATIDE ZEPBOUND (AUTOINJECTOR)	217806 Product 217806/006	SOLUTION · SUBCUTANEOUS 15MG/0.5ML (15MG/0.5ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	8
TIRZEPATIDE ZEPBOUND KWIKPEN	217806 Product 217806/019	SOLUTION · SUBCUTANEOUS 10MG/2.4ML (4.17MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE ZEPBOUND KWIKPEN	217806 Product 217806/020	SOLUTION · SUBCUTANEOUS 20MG/2.4ML (8.33MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE ZEPBOUND KWIKPEN	217806 Product 217806/021	SOLUTION · SUBCUTANEOUS 30MG/2.4ML (12.5MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE ZEPBOUND KWIKPEN	217806 Product 217806/022	SOLUTION · SUBCUTANEOUS 40MG/2.4ML (16.7MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE ZEPBOUND KWIKPEN	217806 Product 217806/023	SOLUTION · SUBCUTANEOUS 50MG/2.4ML (20.8MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
TIRZEPATIDE ZEPBOUND KWIKPEN	217806 Product 217806/024	SOLUTION · SUBCUTANEOUS 60MG/2.4ML (25MG/ML) FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
tislelizumab-jsgr Tevimbra	761232 Product 761232/001	Injection · Intravenous 100MG/10ML (10MG/ML) Single-Dose Vial FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	1
tisotumab vedotin-tftv Tivdak	761208 Product 761208/001	For Injection · Intravenous 40MG Single-Dose Vial FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	3
tividenofusp alfa-eknm Avlayah	761485 Product 761485/001	For Injection · Intravenous 150MG Single-Dose Vial FDA marketing: Prescription	2038 CANDIDATE FINAL_CHECKING	1
TIVOZANIB HYDROCHLORIDE FOTIVDA	212904 Product 212904/001	CAPSULE · ORAL EQ 0.89MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	2
TIVOZANIB HYDROCHLORIDE FOTIVDA	212904 Product 212904/002	CAPSULE · ORAL EQ 1.34MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	2
TIZANIDINE HYDROCHLORIDE ONTRALFY	216190 Product 216190/001	SOLUTION · ORAL EQ 2MG BASE/5ML FDA marketing: Prescription	2024 DEEP_REVIEW FINAL_CHECKING	2
TOBRAMYCIN BETHKIS	201820 Product 201820/001	SOLUTION · INHALATION 300MG/4ML FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	0
TOBRAMYCIN KITABIS PAK	205433 Product 205433/001	SOLUTION · INHALATION 300MG/5ML FDA marketing: Prescription	2013 EXISTING_GENERIC DISQUALIFIED	0
TOBRAMYCIN TOBI PODHALER	201688 Product 201688/001	POWDER · INHALATION 28MG FDA marketing: Prescription	2016 DEEP_REVIEW FINAL	2
tocilizumab Actemra	125276 Product 125276/001	Injection · Intravenous 80MG/4ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	35
tocilizumab Actemra	125276 Product 125276/002	Injection · Intravenous 200MG/10ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	35
tocilizumab Actemra	125276 Product 125276/003	Injection · Intravenous 400MG/20ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	35
tocilizumab Actemra	125472 Product 125472/001	Injection · Subcutaneous 162MG/0.9ML Pre-Filled Syringe FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
tocilizumab-aazg Tyenne	761275 Product 761275/001	Injection · Intravenous 80MG/4ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
tocilizumab-aazg Tyenne	761275 Product 761275/002	Injection · Intravenous 200MG/10ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
tocilizumab-aazg Tyenne	761275 Product 761275/003	Injection · Intravenous 400MG/20ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
TOCILIZUMAB-AAZG TYENNE	761449 Product 761449/004	INJECTABLE · SUBCUTANEOUS 162MG/0.9ML FDA marketing: Prescription	Master only	0
tocilizumab-anoh Avtozma	761420 Product 761420/001	Injection · Intravenous 80MG/4ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
tocilizumab-anoh Avtozma	761420 Product 761420/002	Injection · Intravenous 200MG/10ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
tocilizumab-anoh Avtozma	761420 Product 761420/003	Injection · Intravenous 400MG/20ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
TOCILIZUMAB-ANOH AVTOZMA	761420 Product 761420/004	INJECTABLE · SUBCUTANEOUS 162MG/0.9ML FDA marketing: Prescription	Master only	0
TOCILIZUMAB-ANOH AVTOZMA	761498 Product 761498/004	INJECTABLE · SUBCUTANEOUS 162MG/20ML(20MG/ML) FDA marketing: Prescription	Master only	0
tocilizumab-bavi Tofidence	761354 Product 761354/001	Injection · Intravenous 80MG/4ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
tocilizumab-bavi Tofidence	761354 Product 761354/002	Injection · Intravenous 200MG/10ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
tocilizumab-bavi Tofidence	761354 Product 761354/003	Injection · Intravenous 400MG/20ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
TOFACITINIB CITRATE TOFACITINIB CITRATE	219542 Product 219542/002	TABLET, EXTENDED RELEASE · ORAL EQ 22MG BASE FDA marketing: Prescription	Master only	0
TOFACITINIB CITRATE XELJANZ	203214 Product 203214/001	TABLET · ORAL EQ 5MG BASE FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	1
TOFACITINIB CITRATE XELJANZ	203214 Product 203214/002	TABLET · ORAL EQ 10MG BASE FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	1
TOFACITINIB CITRATE XELJANZ	213082 Product 213082/001	SOLUTION · ORAL EQ 1MG BASE/ML FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	1
TOFACITINIB CITRATE XELJANZ XR	208246 Product 208246/001	TABLET, EXTENDED RELEASE · ORAL EQ 11MG BASE FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	3
TOFACITINIB CITRATE XELJANZ XR	208246 Product 208246/002	TABLET, EXTENDED RELEASE · ORAL EQ 22MG BASE FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	3
TOFERSEN QALSODY	215887 Product 215887/001	SOLUTION · INTRATHECAL 100MG/15ML (6.7MG/ML) FDA marketing: Prescription	2035 CANDIDATE FINAL	3
TOLVAPTAN JYNARQUE	204441 Product 204441/001	TABLET · ORAL 15MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	2
TOLVAPTAN JYNARQUE	204441 Product 204441/002	TABLET · ORAL 30MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	2
TOLVAPTAN JYNARQUE	204441 Product 204441/003	TABLET · ORAL 45MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	2
TOLVAPTAN JYNARQUE	204441 Product 204441/004	TABLET · ORAL 60MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	2
TOLVAPTAN JYNARQUE	204441 Product 204441/005	TABLET · ORAL 90MG FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	2
TOPIRAMATE EPRONTIA	214679 Product 214679/001	SOLUTION · ORAL 25MG/ML FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	5
TOPIRAMATE QUDEXY XR	205122 Product 205122/001	CAPSULE, EXTENDED RELEASE · ORAL 25MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	5
TOPIRAMATE QUDEXY XR	205122 Product 205122/002	CAPSULE, EXTENDED RELEASE · ORAL 50MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	5
TOPIRAMATE QUDEXY XR	205122 Product 205122/003	CAPSULE, EXTENDED RELEASE · ORAL 100MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	5
TOPIRAMATE QUDEXY XR	205122 Product 205122/004	CAPSULE, EXTENDED RELEASE · ORAL 150MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	5
TOPIRAMATE QUDEXY XR	205122 Product 205122/005	CAPSULE, EXTENDED RELEASE · ORAL 200MG FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	5
TOPIRAMATE TROKENDI XR	201635 Product 201635/001	CAPSULE, EXTENDED RELEASE · ORAL 25MG FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	10
TOPIRAMATE TROKENDI XR	201635 Product 201635/002	CAPSULE, EXTENDED RELEASE · ORAL 50MG FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	10
TOPIRAMATE TROKENDI XR	201635 Product 201635/003	CAPSULE, EXTENDED RELEASE · ORAL 100MG FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	10
TOPIRAMATE TROKENDI XR	201635 Product 201635/004	CAPSULE, EXTENDED RELEASE · ORAL 200MG FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	10
TOPOTECAN HYDROCHLORIDE TOPOTECAN	200199 Product 200199/001	SOLUTION · INTRAVENOUS EQ 1MG BASE/ML (EQ 1MG BASE/ML) FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	0
TOPOTECAN HYDROCHLORIDE TOPOTECAN	200199 Product 200199/002	SOLUTION · INTRAVENOUS EQ 3MG BASE/3ML (EQ 1MG BASE/ML) FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	0
TOPOTECAN HYDROCHLORIDE TOPOTECAN	200199 Product 200199/003	SOLUTION · INTRAVENOUS EQ 4MG BASE/4ML (EQ 1MG BASE/ML) FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	0
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE	022453 Product 022453/001	SOLUTION · INTRAVENOUS EQ 4MG BASE/4ML (EQ 1MG BASE/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE	200582 Product 200582/001	SOLUTION · INTRAVENOUS EQ 4MG BASE/4ML (EQ 1MG BASE/ML) FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
toripalimab-tpzi Loqtorzi	761240 Product 761240/001	Injection · Intravenous 240MG/6ML (40MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	2
TORSEMIDE SOAANZ	213218 Product 213218/001	TABLET · ORAL 20MG FDA marketing: Discontinued	DISCONTINUED FINAL	1
TORSEMIDE SOAANZ	213218 Product 213218/002	TABLET · ORAL 60MG FDA marketing: Discontinued	2023 DISCONTINUED FINAL	1
TORSEMIDE SOAANZ	213218 Product 213218/003	TABLET · ORAL 40MG FDA marketing: Prescription	1998 DEEP_REVIEW FINAL	1
TOVORAFENIB OJEMDA	217700 Product 217700/001	TABLET · ORAL 100MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	2
TOVORAFENIB OJEMDA	218033 Product 218033/001	FOR SUSPENSION · ORAL 25MG/ML FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	2
TRABECTEDIN EVDI	220837 Product 220837/001	SOLUTION · INTRAVENOUS 1MG/20ML (0.05MG/ML) FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	1
TRABECTEDIN TRABECTEDIN	219617 Product 219617/001	POWDER · INTRAVENOUS 1MG/VIAL FDA marketing: Prescription	Master only	0
TRABECTEDIN YONDELIS	207953 Product 207953/001	POWDER · INTRAVENOUS 1MG/VIAL FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
TRADIPITANT NEREUS	220152 Product 220152/001	CAPSULE · ORAL 85MG FDA marketing: Prescription	2036 DEEP_REVIEW FINAL	4
tralokinumab-ldrm Adbry	761180 Product 761180/001	Injection · Subcutaneous 150MG/ML Pre-Filled Syringe FDA marketing: Prescription	2033 CANDIDATE FINAL_CHECKING	1
TRAMADOL HYDROCHLORIDE CONZIP	022370 Product 022370/001	CAPSULE, EXTENDED RELEASE · ORAL 100MG FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	1
TRAMADOL HYDROCHLORIDE CONZIP	022370 Product 022370/002	CAPSULE, EXTENDED RELEASE · ORAL 200MG FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	1
TRAMADOL HYDROCHLORIDE CONZIP	022370 Product 022370/003	CAPSULE, EXTENDED RELEASE · ORAL 300MG FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	1
TRAMADOL HYDROCHLORIDE CONZIP	022370 Product 022370/004	CAPSULE, EXTENDED RELEASE · ORAL 150MG FDA marketing: Discontinued	2020 DISCONTINUED FINAL	0
TRAMADOL HYDROCHLORIDE QDOLO	214044 Product 214044/001	SOLUTION · ORAL 5MG/ML FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	2
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST	204114 Product 204114/001	TABLET · ORAL EQ 0.5MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	8
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST	204114 Product 204114/002	TABLET · ORAL EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2017 DISQUALIFIED FINAL	8
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST	204114 Product 204114/003	TABLET · ORAL EQ 2MG FDA marketing: Prescription	EXISTING_GENERIC COMPLETED	8
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST	217513 Product 217513/001	SOLUTION · ORAL EQ 0.05MG BASE/ML FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	2
TRANEXAMIC ACID TRANEXAMIC ACID	212020 Product 212020/001	SOLUTION · INTRAVENOUS 1GM/100ML (10MG/ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
trastuzumab Herceptin	103792 Product 103792/001	For Injection · Intravenous 420MG Multi-Dose Vial FDA marketing: Disc*	2021 DISCONTINUED FINAL	4
trastuzumab Herceptin	103792 Product 103792/002	For Injection · Intravenous 150MG Single-Dose Vial FDA marketing: Rx	2010 DEEP_REVIEW FINAL	4
trastuzumab and hyaluronidase-oysk Herceptin Hylecta	761106 Product 761106/001	Injection · Subcutaneous 600MG/5ML;10,000 UNITS/5ML (120MG/2,000UNITS/ML) Single-Dose Vial FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	0
trastuzumab-anns Kanjinti	761073 Product 761073/001	For Injection · Intravenous 420MG Multi-Dose Vial FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
trastuzumab-anns Kanjinti	761073 Product 761073/002	For Injection · Intravenous 150MG Single-Dose Vial FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
trastuzumab-dkst Ogivri	761074 Product 761074/001	For Injection · Intravenous 420MG Multi-Dose Vial FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
trastuzumab-dttb Ontruzant	761100 Product 761100/001	For Injection · Intravenous 150MG Single-Dose Vial FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
trastuzumab-dttb Ontruzant	761100 Product 761100/002	For Injection · Intravenous 420MG Multi-Dose Vial FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
trastuzumab-pkrb Herzuma	761091 Product 761091/001	For Injection · Intravenous 420MG Multi-Dose Vial FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
trastuzumab-qyyp Trazimera	761081 Product 761081/001	For Injection · Intravenous 420MG Multi-Dose Vial FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
trastuzumab-strf Hercessi	761346 Product 761346/001	For Injection · Intravenous 150MG Single-Dose Vial FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
TRAVOPROST IDOSE TR	218010 Product 218010/001	IMPLANT · INTRACAMERAL 75MCG FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	4
TRAVOPROST IZBA	204822 Product 204822/001	SOLUTION/DROPS · OPHTHALMIC 0.003% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2017 DEEP_REVIEW FINAL_CHECKING	4
TRAZODONE HYDROCHLORIDE OLEPTRO	022411 Product 022411/001	TABLET, EXTENDED RELEASE · ORAL 150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2015 DISQUALIFIED FINAL	2
TRAZODONE HYDROCHLORIDE OLEPTRO	022411 Product 022411/002	TABLET, EXTENDED RELEASE · ORAL 300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2015 DISQUALIFIED FINAL	2
TRAZODONE HYDROCHLORIDE RALDESY	218637 Product 218637/001	SOLUTION · ORAL 10MG/ML FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	1
tremelimumab-actl Imjudo	761289 Product 761289/001	Injection · Intravenous 25MG/1.25ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2034 DEEP_REVIEW FINAL_CHECKING	3
tremelimumab-actl Imjudo	761289 Product 761289/002	Injection · Intravenous 300MG/15ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2034 DEEP_REVIEW FINAL_CHECKING	3
TREOSULFAN GRAFAPEX	214759 Product 214759/001	POWDER · INTRAVENOUS 1GM/VIAL FDA marketing: Prescription	2032 CANDIDATE FINAL	1
TREOSULFAN GRAFAPEX	214759 Product 214759/002	POWDER · INTRAVENOUS 5GM/VIAL FDA marketing: Prescription	2032 CANDIDATE FINAL	1
TREPROSTINIL REMODULIN	021272 Product 021272/005	INJECTABLE · INTRAVENOUS, SUBCUTANEOUS 20MG/ML FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	5
TREPROSTINIL REMODULIN	021272 Product 021272/006	INJECTABLE · INTRAVENOUS, SUBCUTANEOUS 0.1MG/ML FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	5
TREPROSTINIL REMODULIN	021272 Product 021272/007	INJECTABLE · INTRAVENOUS, SUBCUTANEOUS 0.2MG/ML FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	5
TREPROSTINIL REMODULIN	021272 Product 021272/008	INJECTABLE · INTRAVENOUS, SUBCUTANEOUS 0.4MG/ML FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	5
TREPROSTINIL REMODULIN	208276 Product 208276/001	SOLUTION · INTRAVENOUS, SUBCUTANEOUS 20MG/20ML (1MG/ML) FDA marketing: DISCONTINUED	2021 DISQUALIFIED FINAL	1
TREPROSTINIL REMODULIN	208276 Product 208276/002	SOLUTION · INTRAVENOUS, SUBCUTANEOUS 50MG/20ML (2.5MG/ML) FDA marketing: DISCONTINUED	2021 DISQUALIFIED FINAL	1
TREPROSTINIL REMODULIN	208276 Product 208276/003	SOLUTION · INTRAVENOUS, SUBCUTANEOUS 100MG/20ML (5MG/ML) FDA marketing: DISCONTINUED	2021 DISQUALIFIED FINAL	1
TREPROSTINIL REMODULIN	208276 Product 208276/004	SOLUTION · INTRAVENOUS, SUBCUTANEOUS 200MG/20ML (10MG/ML) FDA marketing: DISCONTINUED	2021 DISQUALIFIED FINAL	1
TREPROSTINIL TYVASO DPI	214324 Product 214324/001	POWDER · INHALATION 0.016MG/INH FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	7
TREPROSTINIL TYVASO DPI	214324 Product 214324/002	POWDER · INHALATION 0.032MG/INH FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	7
TREPROSTINIL TYVASO DPI	214324 Product 214324/003	POWDER · INHALATION 0.048MG/INH FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	7
TREPROSTINIL TYVASO DPI	214324 Product 214324/004	POWDER · INHALATION 0.064MG/INH FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	7
TREPROSTINIL TYVASO DPI	214324 Product 214324/005	POWDER · INHALATION 0.08MG/INH FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	7
TREPROSTINIL DIOLAMINE ORENITRAM	203496 Product 203496/001	TABLET, EXTENDED RELEASE · ORAL EQ 0.125MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	8
TREPROSTINIL DIOLAMINE ORENITRAM	203496 Product 203496/002	TABLET, EXTENDED RELEASE · ORAL EQ 0.25MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	8
TREPROSTINIL DIOLAMINE ORENITRAM	203496 Product 203496/003	TABLET, EXTENDED RELEASE · ORAL EQ 1MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	8
TREPROSTINIL DIOLAMINE ORENITRAM	203496 Product 203496/004	TABLET, EXTENDED RELEASE · ORAL EQ 2.5MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	8
TREPROSTINIL DIOLAMINE ORENITRAM	203496 Product 203496/005	TABLET, EXTENDED RELEASE · ORAL EQ 5MG BASE FDA marketing: Prescription	2026 DEEP_REVIEW FINAL	8
TREPROSTINIL SODIUM YUTREPIA	213005 Product 213005/001	POWDER · INHALATION EQ 0.0265MG BASE/INH FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	6
TREPROSTINIL SODIUM YUTREPIA	213005 Product 213005/002	POWDER · INHALATION EQ 0.053MG BASE/INH FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	6
TREPROSTINIL SODIUM YUTREPIA	213005 Product 213005/003	POWDER · INHALATION EQ 0.0795MG BASE/INH FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	6
TREPROSTINIL SODIUM YUTREPIA	213005 Product 213005/004	POWDER · INHALATION EQ 0.106MG BASE/INH FDA marketing: Prescription	2028 DEEP_REVIEW FINAL_CHECKING	6
TRETINOIN ALTRENO	209353 Product 209353/001	LOTION · TOPICAL 0.05% FDA marketing: Prescription	2021 DEEP_REVIEW FINAL_CHECKING	2
TRETINOIN RETIN-A-MICRO	020475 Product 020475/003	GEL · TOPICAL 0.08% FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
TRETINOIN RETIN-A-MICRO	020475 Product 020475/004	GEL · TOPICAL 0.06% FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	0
TRETINOIN TRETINOIN	218560 Product 218560/001	CREAM · TOPICAL 0.025% FDA marketing: Prescription	Master only	0
TRIAMCINOLONE ACETONIDE KENALOG-80	014901 Product 014901/002	INJECTABLE · INJECTION 80MG/ML FDA marketing: Prescription	2019 DEEP_REVIEW FINAL	0
TRIAMCINOLONE ACETONIDE NASACORT ALLERGY 24 HOUR	020468 Product 020468/002	SPRAY, METERED · NASAL 0.055MG/SPRAY FDA marketing: Over-the-counter	2013 EXCLUDED FINAL	0
TRIAMCINOLONE ACETONIDE XIPERE	211950 Product 211950/001	SUSPENSION · INJECTION 40MG/ML FDA marketing: Prescription	2027 DEEP_REVIEW FINAL_CHECKING	4
TRIAMCINOLONE ACETONIDE ZILRETTA	208845 Product 208845/001	FOR SUSPENSION, EXTENDED RELEASE · INTRA-ARTICULAR 32MG/VIAL FDA marketing: Prescription	2020 DEEP_REVIEW FINAL_CHECKING	2
TRICLABENDAZOLE EGATEN	208711 Product 208711/001	TABLET · ORAL 250MG FDA marketing: Prescription	2026 CANDIDATE FINAL	0
TRIENTINE TETRAHYDROCHLORIDE CUVRIOR	215760 Product 215760/001	TABLET · ORAL 300MG FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	5
TRIFAROTENE AKLIEF	211527 Product 211527/001	CREAM · TOPICAL 0.005% FDA marketing: Prescription	Master only	3
TRIHEPTANOIN DOJOLVI	213687 Product 213687/001	LIQUID · ORAL 100% w/w FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	2
TRILACICLIB DIHYDROCHLORIDE COSELA	214200 Product 214200/001	POWDER · INTRAVENOUS EQ 300MG BASE/VIAL FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	14
TRIPTORELIN PAMOATE TRELSTAR	022437 Product 022437/001	INJECTABLE · INTRAMUSCULAR EQ 22.5MG BASE/VIAL FDA marketing: Prescription	2013 DEEP_REVIEW FINAL_CHECKING	1
TRIPTORELIN PAMOATE TRIPTODUR KIT	208956 Product 208956/001	FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR EQ 22.5MG BASE/VIAL FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	1
TROFINETIDE DAYBUE	217026 Product 217026/001	SOLUTION · ORAL 200MG/ML FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	4
TROFINETIDE DAYBUE STIX	219884 Product 219884/001	FOR SOLUTION · ORAL 5000MG/PACKET FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	4
TROFINETIDE DAYBUE STIX	219884 Product 219884/002	FOR SOLUTION · ORAL 6000MG/PACKET FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	4
TROFINETIDE DAYBUE STIX	219884 Product 219884/003	FOR SOLUTION · ORAL 8000MG/PACKET FDA marketing: Prescription	2032 DEEP_REVIEW FINAL	4
TROFINETIDE DAYBUE STIX	219884 Product 219884/004	SOLUTION · ORAL 10,000MG FDA marketing: Prescription	Master only	0
TROFINETIDE DAYBUE STIX	219884 Product 219884/005	SOLUTION · ORAL 12,000MG FDA marketing: Prescription	Master only	0
TROSPIUM CHLORIDE; XANOMELINE TARTRATE COBENFY	216158 Product 216158/001	CAPSULE · ORAL 20MG;EQ 50MG BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL_CHECKING	11
TROSPIUM CHLORIDE; XANOMELINE TARTRATE COBENFY	216158 Product 216158/002	CAPSULE · ORAL 20MG;EQ 100MG BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL_CHECKING	11
TROSPIUM CHLORIDE; XANOMELINE TARTRATE COBENFY	216158 Product 216158/003	CAPSULE · ORAL 30MG;EQ 125MG BASE FDA marketing: Prescription	2030 DEEP_REVIEW FINAL_CHECKING	11
TUCATINIB TUKYSA	213411 Product 213411/001	TABLET · ORAL 50MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	7
TUCATINIB TUKYSA	213411 Product 213411/002	TABLET · ORAL 150MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	7
ublituximab-xiiy Briumvi	761238 Product 761238/001	Injection · Intravenous 150MG/6ML (25MG/ML) Single-Dose Vial FDA marketing: Prescription	2034 CANDIDATE FINAL_CHECKING	2
UBROGEPANT UBRELVY	211765 Product 211765/001	TABLET · ORAL 50MG FDA marketing: RX	2033 DEEP_REVIEW FINAL	15
UBROGEPANT UBRELVY	211765 Product 211765/002	TABLET · ORAL 100MG FDA marketing: RX	2033 DEEP_REVIEW FINAL	12
ULIPRISTAL ACETATE ELLA	022474 Product 022474/001	TABLET · ORAL 30MG FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	8
UMBRALISIB TOSYLATE UKONIQ	213176 Product 213176/001	TABLET · ORAL EQ 200MG BASE FDA marketing: WITHDRAWN	2022 DISQUALIFIED FINAL	8
UMECLIDINIUM BROMIDE INCRUSE ELLIPTA	205382 Product 205382/001	POWDER · INHALATION EQ 0.0625MG BASE/INH FDA marketing: Prescription	2027 CANDIDATE FINAL	1
UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE ANORO ELLIPTA	203975 Product 203975/001	POWDER · INHALATION EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH FDA marketing: Prescription	2030 CANDIDATE FINAL	5
UPADACITINIB RINVOQ	211675 Product 211675/001	TABLET, EXTENDED RELEASE · ORAL 15MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	37
UPADACITINIB RINVOQ	211675 Product 211675/002	TABLET, EXTENDED RELEASE · ORAL 30MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	22
UPADACITINIB RINVOQ	211675 Product 211675/003	TABLET, EXTENDED RELEASE · ORAL 45MG FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	16
UPADACITINIB RINVOQ LQ	218347 Product 218347/001	SOLUTION · ORAL 1MG/ML FDA marketing: Prescription	2033 DEEP_REVIEW FINAL	11
URIDINE TRIACETATE VISTOGARD	208159 Product 208159/001	GRANULE · ORAL 10GM/PACKET FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	1
URIDINE TRIACETATE XURIDEN	208169 Product 208169/001	GRANULE · ORAL 2GM/PACKET FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	1
ustekinumab Stelara	125261 Product 125261/001	Injection · Subcutaneous 45MG/0.5ML Single-Dose Vial FDA marketing: Rx	2023 DEEP_REVIEW FINAL	6
ustekinumab Stelara	125261 Product 125261/002	Injection · Subcutaneous 90MG/ML Single-Dose Vial FDA marketing: Disc	DISCONTINUED FINAL	6
ustekinumab Stelara	125261 Product 125261/003	Injection · Subcutaneous 45MG/0.5ML Pre-Filled Syringe FDA marketing: Rx	2023 DEEP_REVIEW FINAL	6
ustekinumab Stelara	125261 Product 125261/004	Injection · Subcutaneous 90MG/ML Pre-Filled Syringe FDA marketing: Rx	2023 DEEP_REVIEW FINAL	6
ustekinumab Stelara	761044 Product 761044/001	Injection · Intravenous 130MG/26ML (5MG/ML) Single-Dose Vial FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	6
ustekinumab-aauz Otulfi	761379 Product 761379/001	Injection · Subcutaneous 45MG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-aauz Otulfi	761379 Product 761379/002	Injection · Subcutaneous 90MG/ML Pre-Filled Syringe FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-aauz Otulfi	761379 Product 761379/003	Injection · Intravenous 130MG/26ML (5MG/ML) Single-Dose Vial FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-aekn Selarsdi	761343 Product 761343/001	Injection · Subcutaneous 45MG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-aekn Selarsdi	761343 Product 761343/002	Injection · Subcutaneous 90MG/ML Pre-Filled Syringe FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-auub Wezlana	761285 Product 761285/001	Injection · Subcutaneous 45MG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-auub Wezlana	761285 Product 761285/002	Injection · Subcutaneous 90MG/ML Pre-Filled Syringe FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-auub Wezlana	761331 Product 761331/001	Injection · Intravenous 130MG/26ML (5MG/ML) Single-Dose Vial FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-hmny Starjemza	761419 Product 761419/001	Injection · Subcutaneous 45MG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-hmny Starjemza	761419 Product 761419/003	Injection · Subcutaneous 45MG/0.5ML Single-Dose Vial FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-hmny Starjemza	761419 Product 761419/004	Injection · Intravenous 130MG/26ML (5MG/ML) Single-Dose Vial FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-kfce Yesintek	761406 Product 761406/001	Injection · Subcutaneous 45MG/0.5ML Single-Dose Vial FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-kfce Yesintek	761406 Product 761406/002	Injection · Subcutaneous 45MG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-srlf Imuldosa	761364 Product 761364/001	Injection · Subcutaneous 45MG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-srlf Imuldosa	761364 Product 761364/002	Injection · Subcutaneous 90MG/ML Pre-Filled Syringe FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-srlf Imuldosa	761364 Product 761364/003	Injection · Intravenous 130MG/26ML (5MG/ML) Single-Dose Vial FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-stba Steqeyma	761338 Product 761338/001	Injection · Subcutaneous 45MG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-stba Steqeyma	761338 Product 761338/002	Injection · Subcutaneous 90MG/ML Pre-Filled Syringe FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-stba Steqeyma	761338 Product 761338/003	Injection · Intravenous 130MG/26ML (5MG/ML) Single-Dose Vial FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-ttwe Pyzchiva	761373 Product 761373/001	Injection · Subcutaneous 45MG/0.5ML Pre-Filled Syringe FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-ttwe Pyzchiva	761373 Product 761373/002	Injection · Subcutaneous 90MG/ML Pre-Filled Syringe FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
ustekinumab-ttwe Pyzchiva	761425 Product 761425/001	Injection · Intravenous 130MG/26ML (5MG/ML) Single-Dose Vial FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
VADADUSTAT VAFSEO	215192 Product 215192/001	TABLET · ORAL 150MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	14
VADADUSTAT VAFSEO	215192 Product 215192/002	TABLET · ORAL 300MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	14
VADADUSTAT VAFSEO	215192 Product 215192/003	TABLET · ORAL 450MG FDA marketing: DISCONTINUED	2026 DISQUALIFIED FINAL	14
VALBENAZINE TOSYLATE INGREZZA	209241 Product 209241/001	CAPSULE · ORAL EQ 40MG BASE FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	22
VALBENAZINE TOSYLATE INGREZZA	209241 Product 209241/002	CAPSULE · ORAL EQ 80MG BASE FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	22
VALBENAZINE TOSYLATE INGREZZA	209241 Product 209241/003	CAPSULE · ORAL EQ 60MG BASE FDA marketing: Prescription	2024 EXISTING_GENERIC DISQUALIFIED	22
VALBENAZINE TOSYLATE INGREZZA SPRINKLE	218390 Product 218390/001	CAPSULE · ORAL EQ 40MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	22
VALBENAZINE TOSYLATE INGREZZA SPRINKLE	218390 Product 218390/002	CAPSULE · ORAL EQ 60MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	22
VALBENAZINE TOSYLATE INGREZZA SPRINKLE	218390 Product 218390/003	CAPSULE · ORAL EQ 80MG BASE FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	22
VALSARTAN PREXXARTAN	209139 Product 209139/001	SOLUTION · ORAL 4MG/ML FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
VAMOROLONE AGAMREE	215239 Product 215239/001	SUSPENSION · ORAL 40MG/ML FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	7
VANCOMYCIN VANCOMYCIN	213895 Product 213895/001	SOLUTION · INTRAVENOUS, ORAL 5GM/100ML (50MG/ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	5
VANCOMYCIN HYDROCHLORIDE FIRVANQ KIT	208910 Product 208910/001	FOR SOLUTION · ORAL EQ 25MG BASE/ML FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	7
VANCOMYCIN HYDROCHLORIDE FIRVANQ KIT	208910 Product 208910/002	FOR SOLUTION · ORAL EQ 50MG BASE/ML FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	7
VANCOMYCIN HYDROCHLORIDE TYZAVAN	211962 Product 211962/001	SOLUTION · INTRAVENOUS EQ 500MG BASE/100ML (EQ 5MG BASE/ML) FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	6
VANCOMYCIN HYDROCHLORIDE TYZAVAN	211962 Product 211962/002	SOLUTION · INTRAVENOUS EQ 1GM BASE/200ML (EQ 5MG BASE/ML) FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	6
VANCOMYCIN HYDROCHLORIDE TYZAVAN	211962 Product 211962/003	SOLUTION · INTRAVENOUS EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	6
VANCOMYCIN HYDROCHLORIDE TYZAVAN	211962 Product 211962/004	SOLUTION · INTRAVENOUS EQ 2GM BASE/400ML (EQ 5MG BASE/ML) FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	6
VANCOMYCIN HYDROCHLORIDE TYZAVAN	211962 Product 211962/005	SOLUTION · INTRAVENOUS EQ 750MG BASE/150ML (EQ 5MG BASE/ML) FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	6
VANCOMYCIN HYDROCHLORIDE TYZAVAN	211962 Product 211962/006	SOLUTION · INTRAVENOUS EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	6
VANCOMYCIN HYDROCHLORIDE TYZAVAN	211962 Product 211962/007	SOLUTION · INTRAVENOUS EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	6
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE	209481 Product 209481/001	POWDER · INTRAVENOUS EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2018 DEEP_REVIEW PROVISIONAL	0
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE	209481 Product 209481/002	POWDER · INTRAVENOUS EQ 750MG BASE/VIAL FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	0
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE	209481 Product 209481/003	POWDER · INTRAVENOUS EQ 1.25GM BASE/VIAL FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE	209481 Product 209481/004	POWDER · INTRAVENOUS EQ 1.5GM BASE/VIAL FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	0
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE	209481 Product 209481/005	POWDER · INTRAVENOUS EQ 1.75GM BASE/VIAL FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE	209481 Product 209481/006	POWDER · INTRAVENOUS EQ 2GM BASE/VIAL FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE	210274 Product 210274/001	POWDER · INTRAVENOUS, ORAL EQ 500MG BASE/VIAL FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE	210274 Product 210274/002	POWDER · INTRAVENOUS, ORAL EQ 1GM BASE/VIAL FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE	210274 Product 210274/003	POWDER · INTRAVENOUS, ORAL EQ 5GM BASE/VIAL FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE	210274 Product 210274/004	POWDER · INTRAVENOUS, ORAL EQ 10GM BASE/VIAL FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE	210274 Product 210274/005	POWDER · INTRAVENOUS, ORAL EQ 750MG BASE/VIAL FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE	210274 Product 210274/006	POWDER · INTRAVENOUS, ORAL EQ 1.25GM BASE/VIAL FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE	210274 Product 210274/007	POWDER · INTRAVENOUS, ORAL EQ 1.5MG BASE/VIAL FDA marketing: Prescription	2025 DEEP_REVIEW FINAL	0
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	050671 Product 050671/002	SOLUTION · INTRAVENOUS EQ 750MG BASE/150ML (EQ 5MG BASE/ML) FDA marketing: Prescription	2010 DEEP_REVIEW FINAL	0
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	050671 Product 050671/004	SOLUTION · INTRAVENOUS EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	050671 Product 050671/005	SOLUTION · INTRAVENOUS EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
VANDETANIB CAPRELSA	022405 Product 022405/001	TABLET · ORAL 100MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	1
VANDETANIB CAPRELSA	022405 Product 022405/002	TABLET · ORAL 300MG FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	1
VARDENAFIL HYDROCHLORIDE STAXYN	200179 Product 200179/001	TABLET, ORALLY DISINTEGRATING · ORAL 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2018 DEEP_REVIEW FINAL_CHECKING	1
VARENICLINE TARTRATE TYRVAYA	213978 Product 213978/001	SPRAY · NASAL EQ 0.03MG BASE/SPRAY FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	12
VASOPRESSIN VASOPRESSIN	212593 Product 212593/001	SOLUTION · INTRAVENOUS 20UNITS/ML (20UNITS/ML) FDA marketing: Prescription	2020 DEEP_REVIEW FINAL	0
VASOPRESSIN VASOPRESSIN	212593 Product 212593/002	SOLUTION · INTRAVENOUS 200UNITS/10ML (20UNITS/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	0
VASOPRESSIN VASOPRESSIN IN SODIUM CHLORIDE 0.9%	217569 Product 217569/001	SOLUTION · INTRAVENOUS 20UNITS/100ML (0.2UNITS/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
VASOPRESSIN VASOPRESSIN IN SODIUM CHLORIDE 0.9%	217569 Product 217569/002	SOLUTION · INTRAVENOUS 40UNITS/100ML (0.4UNITS/ML) FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
VASOPRESSIN VASOPRESSIN IN SODIUM CHLORIDE 0.9%	217766 Product 217766/001	SOLUTION · INTRAVENOUS 20UNITS/100ML (0.2UNITS/ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
VASOPRESSIN VASOPRESSIN IN SODIUM CHLORIDE 0.9%	217766 Product 217766/002	SOLUTION · INTRAVENOUS 40UNITS/100ML (0.4UNITS/ML) FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	0
VASOPRESSIN VASOPRESSIN IN SODIUM CHLORIDE 0.9%	217766 Product 217766/003	SOLUTION · INTRAVENOUS 50UNITS/50ML (1UNIT/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2025 DISQUALIFIED FINAL	0
VASOPRESSIN VASOSTRICT	204485 Product 204485/001	SOLUTION · INTRAVENOUS 20UNITS/ML (20UNITS/ML) FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	5
VASOPRESSIN VASOSTRICT	204485 Product 204485/002	SOLUTION · INTRAVENOUS 200UNITS/10ML (20UNITS/ML) FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	6
VASOPRESSIN VASOSTRICT	204485 Product 204485/003	SOLUTION · INTRAVENOUS 40UNITS/100ML (0.4UNITS/ML) FDA marketing: Prescription	2025 EXISTING_GENERIC DISQUALIFIED	9
VASOPRESSIN VASOSTRICT	204485 Product 204485/004	SOLUTION · INTRAVENOUS 60UNITS/100ML (0.6UNITS/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	9
VASOPRESSIN VASOSTRICT	204485 Product 204485/005	SOLUTION · INTRAVENOUS 20UNITS/100ML (0.2UNITS/ML) FDA marketing: Prescription	2023 EXISTING_GENERIC DISQUALIFIED	9
VASOPRESSIN VASOSTRICT	204485 Product 204485/006	SOLUTION · INTRAVENOUS 50UNITS/50ML (1UNITS/ML) FDA marketing: Discontinued	2023 DISCONTINUED FINAL	9
vedolizumab Entyvio	125476 Product 125476/001	For Injection · Intravenous 300MG Single-Dose Vial FDA marketing: Prescription	2026 CANDIDATE FINAL	0
vedolizumab Entyvio	761133 Product 761133/001	Injection · Subcutaneous 108MG/0.68ML Pre-Filled Syringe FDA marketing: Prescription	2026 CANDIDATE FINAL_CHECKING	1
vedolizumab Entyvio Pen	761133 Product 761133/002	Injection · Subcutaneous 108MG/0.68ML Autoinjector FDA marketing: Prescription	2026 CANDIDATE FINAL_CHECKING	1
velaglucerase alfa VPRIV	022575 Product 022575/001	For Injection · Intravenous 400UNITS Single-Dose Vial FDA marketing: Prescription	2022 DEEP_REVIEW FINAL	0
velaglucerase alfa VPRIV	022575 Product 022575/002	For Injection · Intravenous 200UNITS Single-Dose Vial FDA marketing: Discontinued	2013 DISCONTINUED FINAL	0
veligrotug-vvze Lumvoa	761530 Product 761530/001	Injection · Intravenous 500MG/10ML (50MG/ML) Single-Dose Vial FDA marketing: Prescription	2038 DEEP_REVIEW FINAL_CHECKING	3
velmanase alfa-tycv Lamzede	761278 Product 761278/001	For Injection · Intravenous 10MG Single-Dose Vial FDA marketing: Prescription	2035 CANDIDATE FINAL_CHECKING	1
VEMURAFENIB ZELBORAF	202429 Product 202429/001	TABLET · ORAL 240MG FDA marketing: Prescription	2029 DEEP_REVIEW FINAL	6
VENETOCLAX VENCLEXTA	208573 Product 208573/001	TABLET · ORAL 10MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	10
VENETOCLAX VENCLEXTA	208573 Product 208573/002	TABLET · ORAL 50MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	10
VENETOCLAX VENCLEXTA	208573 Product 208573/003	TABLET · ORAL 100MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	10
VENLAFAXINE BESYLATE VENLAFAXINE BESYLATE	215429 Product 215429/001	TABLET, EXTENDED RELEASE · ORAL EQ 112.5MG BASE FDA marketing: Prescription	2023 DEEP_REVIEW FINAL	1
VEPDEGESTRANT VEPPANU	219835 Product 219835/001	TABLET · ORAL 100MG FDA marketing: Prescription	2038 CANDIDATE FINAL	3
VEPDEGESTRANT VEPPANU	219835 Product 219835/002	TABLET · ORAL 200MG FDA marketing: Prescription	2038 CANDIDATE FINAL	3
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE	018925 Product 018925/002	SOLUTION · INTRAVENOUS 10MG/4ML (2.5MG/ML) FDA marketing: Discontinued	DISCONTINUED FINAL	0
VERICIGUAT VERQUVO	214377 Product 214377/001	TABLET · ORAL 2.5MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	6
VERICIGUAT VERQUVO	214377 Product 214377/002	TABLET · ORAL 5MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	6
VERICIGUAT VERQUVO	214377 Product 214377/003	TABLET · ORAL 10MG FDA marketing: Prescription	2031 DEEP_REVIEW FINAL	6
vestronidase alfa-vjbk Mepsevii	761047 Product 761047/001	Injection · Intravenous 10MG/5ML (2MG/ML) Single-Dose Vial FDA marketing: Prescription	2035 CANDIDATE FINAL	0
VIBEGRON GEMTESA	213006 Product 213006/001	TABLET · ORAL 75MG FDA marketing: Prescription	2040 DEEP_REVIEW FINAL	5
VIGABATRIN VIGAFYDE	217684 Product 217684/001	SOLUTION · ORAL 100MG/ML FDA marketing: Prescription	2024 DEEP_REVIEW FINAL	3
VILAZODONE HYDROCHLORIDE VIIBRYD	022567 Product 022567/001	TABLET · ORAL 10MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	0
VILAZODONE HYDROCHLORIDE VIIBRYD	022567 Product 022567/002	TABLET · ORAL 20MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	0
VILAZODONE HYDROCHLORIDE VIIBRYD	022567 Product 022567/003	TABLET · ORAL 40MG FDA marketing: Prescription	2019 EXISTING_GENERIC DISQUALIFIED	0
VILOXAZINE HYDROCHLORIDE QELBREE	211964 Product 211964/001	CAPSULE, EXTENDED RELEASE · ORAL EQ 100MG BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL_CHECKING	6
VILOXAZINE HYDROCHLORIDE QELBREE	211964 Product 211964/002	CAPSULE, EXTENDED RELEASE · ORAL EQ 150MG BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL_CHECKING	6
VILOXAZINE HYDROCHLORIDE QELBREE	211964 Product 211964/003	CAPSULE, EXTENDED RELEASE · ORAL EQ 200MG BASE FDA marketing: Prescription	2029 DEEP_REVIEW FINAL_CHECKING	6
VILTOLARSEN VILTEPSO	212154 Product 212154/001	SOLUTION · INTRAVENOUS 250MG/5ML (50MG/ML) FDA marketing: Prescription	2034 CANDIDATE FINAL	2
VIMSELTINIB ROMVIMZA	219304 Product 219304/001	CAPSULE · ORAL 14MG FDA marketing: Prescription	2040 DEEP_REVIEW FINAL	13
VIMSELTINIB ROMVIMZA	219304 Product 219304/002	CAPSULE · ORAL 20MG FDA marketing: Prescription	2040 DEEP_REVIEW FINAL	13
VIMSELTINIB ROMVIMZA	219304 Product 219304/003	CAPSULE · ORAL 30MG FDA marketing: Prescription	2040 DEEP_REVIEW FINAL	13
VINCRISTINE SULFATE MARQIBO KIT	202497 Product 202497/001	INJECTABLE, LIPOSOMAL · INTRAVENOUS 5MG/5ML (1MG/ML) FDA marketing: Discontinued	2022 WITHDRAWN FINAL	6
VISMODEGIB ERIVEDGE	203388 Product 203388/001	CAPSULE · ORAL 150MG FDA marketing: Prescription	2028 CANDIDATE FINAL	2
VOCLOSPORIN LUPKYNIS	213716 Product 213716/001	CAPSULE · ORAL 7.9MG FDA marketing: Prescription	2027 DEEP_REVIEW FINAL	3
VONOPRAZAN FUMARATE VOQUEZNA	215151 Product 215151/001	TABLET · ORAL EQ 10MG BASE FDA marketing: Prescription	2032 CANDIDATE FINAL	2
VONOPRAZAN FUMARATE VOQUEZNA	215151 Product 215151/002	TABLET · ORAL EQ 20MG BASE FDA marketing: Prescription	2032 CANDIDATE FINAL	2
VORAPAXAR SULFATE ZONTIVITY	204886 Product 204886/001	TABLET · ORAL EQ 2.08MG BASE FDA marketing: Discontinued	Master only	1
VORASIDENIB VORANIGO	218784 Product 218784/001	TABLET · ORAL 10MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	5
VORASIDENIB VORANIGO	218784 Product 218784/002	TABLET · ORAL 40MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	5
VORICONAZOLE VORICONAZOLE	208562 Product 208562/001	POWDER · INTRAVENOUS 200MG/VIAL FDA marketing: Prescription	2012 EXISTING_GENERIC DISQUALIFIED	0
VORTIOXETINE HYDROBROMIDE TRINTELLIX	204447 Product 204447/001	TABLET · ORAL EQ 5MG BASE FDA marketing: RX	2026 DEEP_REVIEW FINAL	10
VORTIOXETINE HYDROBROMIDE TRINTELLIX	204447 Product 204447/002	TABLET · ORAL EQ 10MG BASE FDA marketing: RX	2026 DEEP_REVIEW FINAL	10
VORTIOXETINE HYDROBROMIDE TRINTELLIX	204447 Product 204447/003	TABLET · ORAL EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: DISCONTINUED	2017 DISQUALIFIED FINAL	10
VORTIOXETINE HYDROBROMIDE TRINTELLIX	204447 Product 204447/004	TABLET · ORAL EQ 20MG BASE FDA marketing: RX	2026 DEEP_REVIEW FINAL	10
VOSORITIDE VOXZOGO	214938 Product 214938/001	POWDER · SUBCUTANEOUS 0.4MG/VIAL FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	8
VOSORITIDE VOXZOGO	214938 Product 214938/002	POWDER · SUBCUTANEOUS 0.56MG/VIAL FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	8
VOSORITIDE VOXZOGO	214938 Product 214938/003	POWDER · SUBCUTANEOUS 1.2MG/VIAL FDA marketing: Prescription	2035 DEEP_REVIEW FINAL	8
VOXELOTOR OXBRYTA	213137 Product 213137/001	TABLET · ORAL 500MG FDA marketing: DISCONTINUED	2024 DISQUALIFIED FINAL	11
VOXELOTOR OXBRYTA	213137 Product 213137/002	TABLET · ORAL 300MG FDA marketing: DISCONTINUED	2024 DISQUALIFIED FINAL	11
VOXELOTOR OXBRYTA	216157 Product 216157/001	TABLET, FOR SUSPENSION · ORAL 300MG FDA marketing: DISCONTINUED	2024 DISQUALIFIED FINAL	10
VUTRISIRAN SODIUM AMVUTTRA	215515 Product 215515/001	SOLUTION · SUBCUTANEOUS EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) FDA marketing: Prescription	2036 CANDIDATE FINAL	13
XENON XE-129 HYPERPOLARIZED XENOVIEW	214375 Product 214375/001	GAS · INHALATION N/A FDA marketing: Prescription	2022 EXCLUDED FINAL	2
XYZAL XYZAL	022064 Product 022064/001	— 5MG	2010 EXISTING_GENERIC VERIFIED	0
XYZAL XYZAL	022157 Product 022157/001	— 2.5MG/5ML	2011 EXISTING_GENERIC VERIFIED	0
zanidatamab-hrii Ziihera	761416 Product 761416/001	For Injection · Intravenous 300MG Single-Dose Vial FDA marketing: Prescription	2036 DEEP_REVIEW FINAL_CHECKING	1
ZANUBRUTINIB BRUKINSA	213217 Product 213217/001	CAPSULE · ORAL 80MG FDA marketing: DISCONTINUED	2025 DISQUALIFIED FINAL	12
ZANUBRUTINIB BRUKINSA	218785 Product 218785/001	TABLET · ORAL 160MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	13
ZAVEGEPANT HYDROCHLORIDE ZAVZPRET	216386 Product 216386/001	SPRAY, METERED · NASAL EQ 10MG BASE/SPRAY FDA marketing: Prescription	2034 CANDIDATE FINAL	1
zenocutuzumab-zbco Bizengri	761352 Product 761352/001	Injection · Intravenous 375MG/18.75ML (20MG/ML) Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	1
ZIDESAMTINIB JIDEYTRO	220185 Product 220185/001	TABLET · ORAL 25MG FDA marketing: Prescription	2041 DEEP_REVIEW FINAL	4
ZIDESAMTINIB JIDEYTRO	220185 Product 220185/002	TABLET · ORAL 100MG FDA marketing: Prescription	2041 DEEP_REVIEW FINAL	4
ZIDOVUDINE ZIDOVUDINE	200732 Product 200732/001	TABLET · ORAL 100MG FDA marketing: Discontinued	DISCONTINUED FINAL_CHECKING	0
ZIFTOMENIB KOMZIFTI	220305 Product 220305/001	CAPSULE · ORAL 200MG FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	8
ZILGANERSEN SODIUM ZANVASTRO	220210 Product 220210/001	SOLUTION · INTRATHECAL EQ 56MG BASE/2.8ML (EQ 20MG BASE/ML) FDA marketing: Prescription	2041 CANDIDATE FINAL	1
ZILUCOPLAN SODIUM ZILBRYSQ	216834 Product 216834/001	SOLUTION · SUBCUTANEOUS EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML) FDA marketing: Prescription	2035 CANDIDATE FINAL	9
ZILUCOPLAN SODIUM ZILBRYSQ	216834 Product 216834/002	SOLUTION · SUBCUTANEOUS EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML) FDA marketing: Prescription	2035 CANDIDATE FINAL	9
ZILUCOPLAN SODIUM ZILBRYSQ	216834 Product 216834/003	SOLUTION · SUBCUTANEOUS EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML) FDA marketing: Prescription	2035 CANDIDATE FINAL	9
ZILURGISERTIB ATEBRIOZ	221198 Product 221198/001	TABLET · ORAL EQ 25MG BASE FDA marketing: Prescription	2037 DEEP_REVIEW FINAL	2
ZINC SULFATE ZINC SULFATE	209377 Product 209377/001	SOLUTION · INTRAVENOUS EQ 30MG BASE/10ML (EQ 3MG BASE/ML) FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
ZINC SULFATE ZINC SULFATE	209377 Product 209377/002	SOLUTION · INTRAVENOUS EQ 25MG BASE/5ML (EQ 5MG BASE/ML) FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
ZINC SULFATE ZINC SULFATE	209377 Product 209377/003	SOLUTION · INTRAVENOUS EQ 10MG BASE/10ML (EQ 1MG BASE/ML) FDA marketing: Prescription	2022 EXISTING_GENERIC DISQUALIFIED	0
ZIV-AFLIBERCEPT ZALTRAP	125418 Product 125418/001	INJECTABLE · INJECTION 4MG FDA marketing: Prescription	Master only	0
zolbetuximab-clzb Vyloy	761365 Product 761365/001	For Injection · Intravenous 100MG Single-Dose Vial FDA marketing: Prescription	2036 CANDIDATE FINAL_CHECKING	1
ZOLEDRONIC ACID ZOLEDRONIC ACID	203231 Product 203231/001	INJECTABLE · INTRAVENOUS EQ 4MG BASE/100ML FDA marketing: Prescription	2017 EXISTING_GENERIC DISQUALIFIED	0
ZOLEDRONIC ACID ZOLEDRONIC ACID	204016 Product 204016/001	SOLUTION · INTRAVENOUS EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) FDA marketing: Discontinued	2026 WITHDRAWN FINAL	0
ZOLEDRONIC ACID ZOMETA	021223 Product 021223/003	INJECTABLE · INTRAVENOUS EQ 4MG BASE/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons FDA marketing: Discontinued	2013 DEEP_REVIEW FINAL_CHECKING	1
ZOLIFLODACIN NUZOLVENCE	219491 Product 219491/001	FOR SUSPENSION · ORAL 3GM/PACKET FDA marketing: Prescription	2035 CANDIDATE FINAL	6
ZOLMITRIPTAN ZOMIG	021450 Product 021450/003	SPRAY · NASAL 2.5MG/SPRAY FDA marketing: Prescription	2021 EXISTING_GENERIC DISQUALIFIED	0
ZOLPIDEM TARTRATE INTERMEZZO	022328 Product 022328/001	TABLET · SUBLINGUAL 1.75MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	2
ZOLPIDEM TARTRATE INTERMEZZO	022328 Product 022328/002	TABLET · SUBLINGUAL 3.5MG FDA marketing: Discontinued	EXISTING_GENERIC COMPLETED	2
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE	215721 Product 215721/001	CAPSULE · ORAL 7.5MG FDA marketing: Prescription	2026 EXISTING_GENERIC DISQUALIFIED	0
ZONGERTINIB HERNEXEOS	219042 Product 219042/001	TABLET · ORAL 60MG FDA marketing: Prescription	2041 CANDIDATE FINAL	2
ZONISAMIDE ZONISADE	214273 Product 214273/001	SUSPENSION · ORAL 100MG/5ML FDA marketing: Prescription	2022 DEEP_REVIEW FINAL_CHECKING	4
ZURANOLONE ZURZUVAE	217369 Product 217369/001	CAPSULE · ORAL 20MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	5
ZURANOLONE ZURZUVAE	217369 Product 217369/002	CAPSULE · ORAL 25MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	5
ZURANOLONE ZURZUVAE	217369 Product 217369/003	CAPSULE · ORAL 30MG FDA marketing: Prescription	2034 DEEP_REVIEW FINAL	5