FDA-approved drug applications

1,146 approved applications across 52 covered sponsors.

Only applications with a unique FDA ORIG/AP approval and an exact-unique sponsor-to-company match are published. Unresolved, tentative, other-status, subsidiary, name-variant, joint-venture, foreign, and private sponsor records are not covered.

FDA data retrieved 2026-08-07. Regulatory listing data as published by FDA; not medical or investment advice.

ABBV — AbbVie Inc.

DECNUPAZ — FDA application BLA761460 — original approval 2026-05-27
EMRELIS — FDA application BLA761384 — original approval 2025-05-14
EMBLAVEO — FDA application NDA217906 — original approval 2025-02-07
VYALEV — FDA application NDA216962 — original approval 2024-10-16
RINVOQ LQ — FDA application NDA218347 — original approval 2024-04-26
SKYRIZI — FDA application BLA761262 — original approval 2022-06-16
VUITY — FDA application NDA214028 — original approval 2021-10-28
QULIPTA — FDA application NDA215206 — original approval 2021-09-28
MAVYRET — FDA application NDA215110 — original approval 2021-06-10
ORIAHNN (COPACKAGED) — FDA application NDA213388 — original approval 2020-05-29
DURYSTA — FDA application NDA211911 — original approval 2020-03-04
UBRELVY — FDA application NDA211765 — original approval 2019-12-23
RINVOQ — FDA application NDA211675 — original approval 2019-08-16
SKYRIZI — FDA application BLA761105 — original approval 2019-04-23
ORILISSA — FDA application NDA210450 — original approval 2018-07-23
MAVYRET — FDA application NDA209394 — original approval 2017-08-03
NORVIR — FDA application NDA209512 — original approval 2017-06-07
VIEKIRA XR — FDA application NDA208624 — original approval 2016-07-22
BYVALSON — FDA application NDA206302 — original approval 2016-06-03
VENCLEXTA — FDA application NDA208573 — original approval 2016-04-11
VRAYLAR — FDA application NDA204370 — original approval 2015-09-17
TECHNIVIE — FDA application NDA207931 — original approval 2015-07-24
VIBERZI — FDA application NDA206940 — original approval 2015-05-27
KYBELLA — FDA application NDA206333 — original approval 2015-04-29
AVYCAZ — FDA application NDA206494 — original approval 2015-02-25
DUOPA — FDA application NDA203952 — original approval 2015-01-09
NAMZARIC — FDA application NDA206439 — original approval 2014-12-23
VIEKIRA PAK (COPACKAGED) — FDA application NDA206619 — original approval 2014-12-19
DALVANCE — FDA application NDA021883 — original approval 2014-05-23
FETZIMA — FDA application NDA204168 — original approval 2013-07-25
DELZICOL — FDA application NDA204412 — original approval 2013-02-01
OXYTROL FOR WOMEN — FDA application NDA202211 — original approval 2013-01-25
LINZESS — FDA application NDA202811 — original approval 2012-08-30
RECTIV — FDA application NDA021359 — original approval 2011-06-21
VIIBRYD — FDA application NDA022567 — original approval 2011-01-21
TEFLARO — FDA application NDA200327 — original approval 2010-10-29
LUMIGAN — FDA application NDA022184 — original approval 2010-08-31
LASTACAFT — FDA application NDA022134 — original approval 2010-07-28
NAMENDA XR — FDA application NDA022525 — original approval 2010-06-21
ZYMAXID — FDA application NDA022548 — original approval 2010-05-18
NORVIR — FDA application NDA022417 — original approval 2010-02-10
SAPHRIS — FDA application NDA022117 — original approval 2009-08-13
ACUVAIL — FDA application NDA022427 — original approval 2009-07-22
OZURDEX — FDA application NDA022315 — original approval 2009-06-17
CREON — FDA application BLA020725 — original approval 2009-04-30
GELNIQUE — FDA application NDA022204 — original approval 2009-01-27
SAVELLA — FDA application NDA022256 — original approval 2009-01-14
LATISSE — FDA application NDA022369 — original approval 2008-12-24
TRILIPIX — FDA application NDA022224 — original approval 2008-12-15
RAPAFLO — FDA application NDA022206 — original approval 2008-10-08
ASACOL HD — FDA application NDA021830 — original approval 2008-05-29
DEPAKOTE ER — FDA application NDA022267 — original approval 2008-03-24
COMBIGAN — FDA application NDA021398 — original approval 2007-10-30
KALETRA — FDA application NDA021906 — original approval 2005-10-28
ALPHAGAN P — FDA application NDA021770 — original approval 2005-08-19
ZEMPLAR — FDA application NDA021606 — original approval 2005-05-26
ENABLEX — FDA application NDA021513 — original approval 2004-12-22
TRICOR — FDA application NDA021656 — original approval 2004-11-05
NAMENDA — FDA application NDA021487 — original approval 2003-10-16
ACULAR LS — FDA application NDA021528 — original approval 2003-05-30
HUMIRA — FDA application BLA125057 — original approval 2002-12-31
RESTASIS / RESTASIS MULTIDOSE — FDA application NDA050790 — original approval 2002-12-23
LEXAPRO — FDA application NDA021365 — original approval 2002-11-27
LEXAPRO — FDA application NDA021323 — original approval 2002-08-14
SYNTHROID — FDA application NDA021402 — original approval 2002-07-24
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER — FDA application ANDA075729 — original approval 2001-12-17
TEVETEN HCT — FDA application NDA021268 — original approval 2001-11-01
TRICOR — FDA application NDA021203 — original approval 2001-09-04
LUMIGAN — FDA application NDA021275 — original approval 2001-03-16
ALPHAGAN P — FDA application NDA021262 — original approval 2001-03-16
CANASA — FDA application NDA021252 — original approval 2001-01-05
KALETRA — FDA application NDA021251 — original approval 2000-09-15
KALETRA — FDA application NDA021226 — original approval 2000-09-15
DEPAKOTE ER — FDA application NDA021168 — original approval 2000-08-04
VANIQA — FDA application NDA021145 — original approval 2000-07-27
GENGRAF — FDA application ANDA065003 — original approval 2000-05-12
BIAXIN XL — FDA application NDA050775 — original approval 2000-03-03
CYCLOSPORINE — FDA application ANDA065025 — original approval 2000-03-03
ACYCLOVIR — FDA application ANDA075114 — original approval 1999-07-26
NORVIR — FDA application NDA020945 — original approval 1999-06-29
CELEXA — FDA application NDA020822 — original approval 1998-07-17
ZEMPLAR — FDA application NDA020819 — original approval 1998-04-17
TEVETEN — FDA application NDA020738 — original approval 1997-12-22
URSO 250 / URSO FORTE — FDA application NDA020675 — original approval 1997-12-10
OMNICEF — FDA application NDA050749 — original approval 1997-12-04
OMNICEF — FDA application NDA050739 — original approval 1997-12-04
VICOPROFEN — FDA application NDA020716 — original approval 1997-09-23
CRINONE — FDA application NDA020701 — original approval 1997-07-31
NIASPAN / NIASPAN TITRATION STARTER PACK — FDA application NDA020381 — original approval 1997-07-28
IOPAMIDOL-300 — FDA application ANDA074638 — original approval 1997-04-30
DEPACON — FDA application NDA020593 — original approval 1996-12-30
ALORA — FDA application NDA020655 — original approval 1996-12-20
TARKA — FDA application NDA020591 — original approval 1996-10-22
VICODIN HP — FDA application ANDA040117 — original approval 1996-09-23
MAVIK — FDA application NDA020528 — original approval 1996-04-26
NORVIR — FDA application NDA020659 — original approval 1996-03-01
NIMBEX / NIMBEX PRESERVATIVE FREE — FDA application NDA020551 — original approval 1995-12-15
ANDRODERM — FDA application NDA020489 — original approval 1995-09-29
ULTANE — FDA application NDA020478 — original approval 1995-06-07
LIPIDIL / TRICOR (MICRONIZED) — FDA application NDA019304 — original approval 1993-12-31
BIAXIN — FDA application NDA050698 — original approval 1993-12-23
BIAXIN XL — FDA application NDA050697 — original approval 1993-12-23
CARAFATE — FDA application NDA019183 — original approval 1993-12-16
NALBUPHINE HYDROCHLORIDE — FDA application NDA020200 — original approval 1993-03-12
ACULAR — FDA application NDA019700 — original approval 1992-11-09
MIVACRON / MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER — FDA application NDA020098 — original approval 1992-01-22
BIAXIN — FDA application NDA050662 — original approval 1991-10-31
SURVANTA — FDA application BLA020032 — original approval 1991-07-01
NUROMAX — FDA application NDA019946 — original approval 1991-03-07
DEPAKOTE — FDA application NDA019680 — original approval 1989-09-12
CARTROL — FDA application NDA019204 — original approval 1988-12-28
VICODIN ES — FDA application ANDA089736 — original approval 1988-12-09
ATROPINE — FDA application ANDA071295 — original approval 1987-01-30
CALCIJEX — FDA application NDA018874 — original approval 1986-09-25
FML FORTE — FDA application NDA019216 — original approval 1986-04-23
ESTRACE — FDA application ANDA086069 — original approval 1984-01-31
DEPAKOTE — FDA application NDA018723 — original approval 1983-03-10
VICODIN — FDA application ANDA088058 — original approval 1983-01-07
AZMACORT — FDA application NDA018117 — original approval 1982-04-23
CARAFATE — FDA application NDA018333 — original approval 1981-10-30
NITROPRESS — FDA application NDA018450 — original approval 1981-09-08
K-TAB — FDA application NDA018279 — original approval 1980-06-09
DEPAKENE — FDA application NDA018082 — original approval 1978-02-28
DEPAKENE — FDA application NDA018081 — original approval 1978-02-28
PRED FORTE — FDA application NDA017011 — original approval 1973-05-30
PRED MILD — FDA application NDA017100 — original approval 1972-11-10
FML — FDA application NDA016851 — original approval 1972-01-12
CHOLOXIN — FDA application NDA012302 — original approval 1967-04-14
PLACIDYL — FDA application NDA010021 — original approval 1961-05-10
AKINETON — FDA application NDA012418 — original approval 1961-04-20
ENDURON — FDA application NDA012524 — original approval 1960-10-21
ORETICYL 25 / ORETICYL 50 / ORETICYL FORTE — FDA application NDA012148 — original approval 1959-12-14
AKINETON — FDA application NDA012003 — original approval 1959-09-08
ORETIC — FDA application NDA011971 — original approval 1959-07-06
HARMONYL — FDA application NDA010796 — original approval 1957-04-19
TRAL — FDA application NDA010599 — original approval 1957-02-13
BENTYL / BENTYL PRESERVATIVE FREE — FDA application NDA008370 — original approval 1952-08-13
PHENURONE — FDA application NDA007707 — original approval 1951-06-28
PARADIONE — FDA application NDA006800 — original approval 1949-06-15
TRIDIONE — FDA application NDA005856 — original approval 1946-01-25
DICUMAROL — FDA application NDA005545 — original approval 1944-07-31

ABT — ABBOTT LABORATORIES

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER — FDA application ANDA065027 — original approval 2001-06-29

ACAD — ACADIA PHARMACEUTICALS INC

DAYBUE STIX — FDA application NDA219884 — original approval 2025-12-11
DAYBUE — FDA application NDA217026 — original approval 2023-03-10
NUPLAZID — FDA application NDA210793 — original approval 2018-06-28
NUPLAZID — FDA application NDA207318 — original approval 2016-04-29

ADCT — ADC Therapeutics SA

ZYNLONTA — FDA application BLA761196 — original approval 2021-04-23

AGIO — AGIOS PHARMACEUTICALS, INC.

AQVESME / PYRUKYND — FDA application NDA216196 — original approval 2022-02-17

ALKS — Alkermes plc.

LYBALVI — FDA application NDA213378 — original approval 2021-05-28
ARISTADA INITIO KIT — FDA application NDA209830 — original approval 2018-06-29
ARISTADA — FDA application NDA207533 — original approval 2015-10-05
VIVITROL — FDA application NDA021897 — original approval 2006-04-13

ALNY — ALNYLAM PHARMACEUTICALS, INC.

AMVUTTRA — FDA application NDA215515 — original approval 2022-06-13
OXLUMO — FDA application NDA214103 — original approval 2020-11-23
GIVLAARI — FDA application NDA212194 — original approval 2019-11-20
ONPATTRO — FDA application NDA210922 — original approval 2018-08-10

AMGN — AMGEN INC

OTEZLA / OTEZLA XR — FDA application NDA210745 — original approval 2025-08-29
PAVBLU — FDA application BLA761298 — original approval 2024-08-23
BKEMV — FDA application BLA761333 — original approval 2024-05-28
IMDELLTRA — FDA application BLA761344 — original approval 2024-05-16
WEZLANA — FDA application BLA761331 — original approval 2023-10-31
WEZLANA — FDA application BLA761285 — original approval 2023-10-31
LUMAKRAS — FDA application NDA214665 — original approval 2021-05-28
RIABNI — FDA application BLA761140 — original approval 2020-12-17
AVSOLA — FDA application BLA761086 — original approval 2019-12-06
KANJINTI — FDA application BLA761073 — original approval 2019-06-13
CORLANOR — FDA application NDA209964 — original approval 2019-04-22
EVENITY — FDA application BLA761062 — original approval 2019-04-09
AIMOVIG — FDA application BLA761077 — original approval 2018-05-17
MVASI — FDA application BLA761028 — original approval 2017-09-14
AMJEVITA — FDA application BLA761024 — original approval 2016-09-23
CORLANOR — FDA application NDA206143 — original approval 2015-04-15
BLINCYTO — FDA application BLA125557 — original approval 2014-12-03
OTEZLA — FDA application NDA205437 — original approval 2014-03-21
PROLIA / XGEVA — FDA application BLA125320 — original approval 2010-06-01
NPLATE — FDA application BLA125268 — original approval 2008-08-22
VECTIBIX — FDA application BLA125147 — original approval 2006-09-27
SENSIPAR — FDA application NDA021688 — original approval 2004-03-08
NEULASTA — FDA application BLA125031 — original approval 2002-01-31
ARANESP — FDA application BLA103951 — original approval 2001-09-17
NEUPOGEN — FDA application BLA103353 — original approval 1991-02-20
EPOGEN/PROCRIT — FDA application BLA103234 — original approval 1989-06-01

AMPH — Amphastar Pharmaceuticals, Inc.

TERIPARATIDE — FDA application ANDA213641 — original approval 2025-12-12
REXTOVY — FDA application NDA208969 — original approval 2023-03-07
VASOPRESSIN — FDA application ANDA211857 — original approval 2022-07-18
GANIRELIX ACETATE — FDA application ANDA212613 — original approval 2022-04-07
GLUCAGON — FDA application ANDA208086 — original approval 2020-12-28
SUCCINYLCHOLINE CHLORIDE — FDA application ANDA213432 — original approval 2020-06-08
BAQSIMI — FDA application NDA210134 — original approval 2019-07-24
ENOXAPARIN SODIUM — FDA application ANDA208600 — original approval 2019-03-14
ISOPROTERENOL HYDROCHLORIDE — FDA application ANDA210106 — original approval 2018-06-18
SODIUM NITROPRUSSIDE — FDA application ANDA209832 — original approval 2017-12-18
MEDROXYPROGESTERONE ACETATE — FDA application ANDA077334 — original approval 2017-11-28
MEDROXYPROGESTERONE ACETATE — FDA application ANDA077235 — original approval 2017-11-28
NEOSTIGMINE METHYLSULFATE — FDA application ANDA209933 — original approval 2017-09-25
DUOCAINE — FDA application NDA021496 — original approval 2003-05-23
CORTROSYN — FDA application NDA016750 — original approval 1970-04-22

AMRX — Amneal Pharmaceuticals, Inc.

OZILTUS — FDA application BLA761457 — original approval 2025-12-19
BONCRESA — FDA application BLA761456 — original approval 2025-12-19
LACOSAMIDE — FDA application ANDA204839 — original approval 2024-03-27
CARBAMAZEPINE — FDA application ANDA212704 — original approval 2023-09-22
VALSARTAN AND HYDROCHLOROTHIAZIDE — FDA application ANDA204382 — original approval 2023-08-11
VIGABATRIN — FDA application ANDA210042 — original approval 2022-06-22
ESTRADIOL AND PROGESTERONE — FDA application ANDA214293 — original approval 2022-05-16
SUCRALFATE — FDA application ANDA215576 — original approval 2022-04-15
ALYMSYS — FDA application BLA761231 — original approval 2022-04-13
LACOSAMIDE — FDA application ANDA204857 — original approval 2022-03-17
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE — FDA application ANDA214292 — original approval 2021-07-20
MONTELUKAST SODIUM — FDA application ANDA205107 — original approval 2020-09-04
DEXMEDETOMIDINE HYDROCHLORIDE — FDA application ANDA207551 — original approval 2020-05-20
SILDENAFIL CITRATE — FDA application ANDA211092 — original approval 2019-11-27
ERYTHROMYCIN ETHYLSUCCINATE — FDA application ANDA211204 — original approval 2019-11-01
PALIPERIDONE — FDA application ANDA204707 — original approval 2019-09-23
PREGABALIN — FDA application ANDA209743 — original approval 2019-07-19
ERYTHROMYCIN — FDA application ANDA210954 — original approval 2019-07-02
CHLORTHALIDONE — FDA application ANDA207204 — original approval 2019-07-01
SOLIFENACIN SUCCINATE — FDA application ANDA209719 — original approval 2019-05-20
BOSENTAN — FDA application ANDA209742 — original approval 2019-04-26
TADALAFIL — FDA application ANDA209744 — original approval 2019-03-26
IMATINIB MESYLATE — FDA application ANDA207495 — original approval 2019-02-08
LEVOMILNACIPRAN HYDROCHLORIDE — FDA application ANDA210790 — original approval 2019-02-04
RIVASTIGMINE — FDA application ANDA207308 — original approval 2019-01-08
ABIRATERONE ACETATE — FDA application ANDA208327 — original approval 2019-01-07
LURASIDONE HYDROCHLORIDE — FDA application ANDA208002 — original approval 2019-01-03
EXEMESTANE — FDA application ANDA206421 — original approval 2018-12-28
SILODOSIN — FDA application ANDA209745 — original approval 2018-12-03
LAMOTRIGINE — FDA application ANDA207497 — original approval 2018-11-30
FROVATRIPTAN SUCCINATE — FDA application ANDA211292 — original approval 2018-11-06
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE — FDA application ANDA209692 — original approval 2018-11-01
CLOMIPRAMINE HYDROCHLORIDE — FDA application ANDA208632 — original approval 2018-10-31
QUETIAPINE FUMARATE — FDA application ANDA211405 — original approval 2018-10-26
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE — FDA application ANDA209726 — original approval 2018-10-23
CLOBAZAM — FDA application ANDA209718 — original approval 2018-10-22
URSODIOL — FDA application ANDA211301 — original approval 2018-10-16
ROSUVASTATIN CALCIUM — FDA application ANDA208850 — original approval 2018-10-16
TERIFLUNOMIDE — FDA application ANDA209613 — original approval 2018-09-28
AMPHETAMINE SULFATE — FDA application ANDA211139 — original approval 2018-09-26
METHYLERGONOVINE MALEATE — FDA application ANDA211483 — original approval 2018-09-10
CHLORPROMAZINE HYDROCHLORIDE — FDA application ANDA209755 — original approval 2018-09-10
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — FDA application ANDA209721 — original approval 2018-08-22
GUAIFENESIN — FDA application ANDA207342 — original approval 2018-07-11
PRASUGREL — FDA application ANDA205913 — original approval 2018-06-19
ETODOLAC — FDA application ANDA208834 — original approval 2018-06-07
CELECOXIB — FDA application ANDA208833 — original approval 2018-05-31
ALBUTEROL SULFATE — FDA application ANDA208804 — original approval 2018-05-21
HYDROXYCHLOROQUINE SULFATE — FDA application ANDA210577 — original approval 2018-05-15
PHYTONADIONE — FDA application ANDA209373 — original approval 2018-05-11
ETHACRYNIC ACID — FDA application ANDA208805 — original approval 2018-05-08
IRBESARTAN — FDA application ANDA204740 — original approval 2018-04-17
VIGABATRIN — FDA application ANDA210155 — original approval 2018-03-13
ERYTHROMYCIN — FDA application ANDA209720 — original approval 2018-03-09
METHYLPHENIDATE HYDROCHLORIDE — FDA application ANDA207515 — original approval 2018-02-01
ARGATROBAN — FDA application ANDA206698 — original approval 2018-01-26
METHOTREXATE SODIUM — FDA application ANDA210040 — original approval 2017-12-22
TIAGABINE HYDROCHLORIDE — FDA application ANDA208181 — original approval 2017-12-08
SEVELAMER CARBONATE — FDA application ANDA207288 — original approval 2017-11-28
EZETIMIBE AND SIMVASTATIN — FDA application ANDA208831 — original approval 2017-11-21
BUMETANIDE — FDA application ANDA209724 — original approval 2017-10-18
DOXYCYCLINE HYCLATE — FDA application ANDA209372 — original approval 2017-10-06
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE — FDA application ANDA207514 — original approval 2017-09-11
BUDESONIDE — FDA application ANDA206200 — original approval 2017-07-31
DOXEPIN HYDROCHLORIDE — FDA application ANDA207482 — original approval 2017-06-28
CALCITRIOL — FDA application ANDA203289 — original approval 2017-06-14
EZETIMIBE — FDA application ANDA208803 — original approval 2017-06-12
NADOLOL — FDA application ANDA208832 — original approval 2017-06-02
BUSPIRONE HYDROCHLORIDE — FDA application ANDA208829 — original approval 2017-05-24
OSELTAMIVIR PHOSPHATE — FDA application ANDA209093 — original approval 2017-05-17
ESCITALOPRAM OXALATE — FDA application ANDA205619 — original approval 2017-05-17
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) — FDA application ANDA207372 — original approval 2017-05-15
OXAPROZIN — FDA application ANDA208633 — original approval 2017-05-04
MOMETASONE FUROATE — FDA application ANDA207989 — original approval 2017-04-03
PARICALCITOL — FDA application ANDA206699 — original approval 2017-03-09
TRANEXAMIC ACID — FDA application ANDA208840 — original approval 2017-02-28
CAPECITABINE — FDA application ANDA204741 — original approval 2017-02-28
ALOSETRON HYDROCHLORIDE — FDA application ANDA206647 — original approval 2016-12-22
HYDROCODONE BITARTRATE AND ACETAMINOPHEN — FDA application ANDA207137 — original approval 2016-11-29
DICLOFENAC SODIUM AND MISOPROSTOL — FDA application ANDA203995 — original approval 2016-11-25
MEMANTINE HYDROCHLORIDE — FDA application ANDA205825 — original approval 2016-10-12
COLCHICINE — FDA application ANDA204711 — original approval 2016-09-28
ITRACONAZOLE — FDA application ANDA205080 — original approval 2016-09-26
DICLOFENAC SODIUM — FDA application ANDA206116 — original approval 2016-09-02
FUROSEMIDE — FDA application ANDA207552 — original approval 2016-07-20
DOXYCYCLINE HYCLATE — FDA application ANDA207289 — original approval 2016-06-27
ARIPIPRAZOLE — FDA application ANDA204838 — original approval 2016-06-17
TEMAZEPAM — FDA application ANDA203482 — original approval 2016-05-23
MILNACIPRAN HYDROCHLORIDE — FDA application ANDA205081 — original approval 2016-04-22
VORICONAZOLE — FDA application ANDA205034 — original approval 2016-04-13
MEROPENEM — FDA application ANDA205883 — original approval 2016-04-12
RALOXIFENE HYDROCHLORIDE — FDA application ANDA208206 — original approval 2016-04-08
DICLOFENAC SODIUM — FDA application ANDA208077 — original approval 2016-03-18
DESIPRAMINE HYDROCHLORIDE — FDA application ANDA208105 — original approval 2016-03-17
ASPIRIN AND DIPYRIDAMOLE — FDA application ANDA206392 — original approval 2016-03-08
PANTOPRAZOLE SODIUM — FDA application ANDA205119 — original approval 2016-01-26
PARICALCITOL — FDA application ANDA204327 — original approval 2016-01-13
VALSARTAN — FDA application ANDA204011 — original approval 2016-01-11
LINEZOLID — FDA application ANDA204536 — original approval 2015-12-21
NIACIN — FDA application ANDA204178 — original approval 2015-12-11
OMEGA-3-ACID ETHYL ESTERS — FDA application ANDA204940 — original approval 2015-11-27
OXYBUTYNIN CHLORIDE — FDA application ANDA204010 — original approval 2015-11-23
DUTASTERIDE — FDA application ANDA203118 — original approval 2015-11-20
ENTECAVIR — FDA application ANDA206652 — original approval 2015-11-12
ITRACONAZOLE — FDA application ANDA205573 — original approval 2015-10-30
TELMISARTAN — FDA application ANDA204415 — original approval 2015-09-08
MONTELUKAST SODIUM — FDA application ANDA204604 — original approval 2015-09-04
PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE — FDA application ANDA200963 — original approval 2015-08-26
ARIPIPRAZOLE — FDA application ANDA203906 — original approval 2015-08-14
LIDOCAINE — FDA application ANDA206297 — original approval 2015-08-07
RABEPRAZOLE SODIUM — FDA application ANDA204179 — original approval 2015-07-31
NIACIN — FDA application ANDA203578 — original approval 2015-07-24
QUININE SULFATE — FDA application ANDA203729 — original approval 2015-07-15
TOBRAMYCIN — FDA application ANDA205501 — original approval 2015-07-13
ESTRADIOL — FDA application ANDA205256 — original approval 2015-05-29
DIVALPROEX SODIUM — FDA application ANDA203730 — original approval 2015-05-29
TEMOZOLOMIDE — FDA application ANDA203691 — original approval 2015-05-08
MEMANTINE HYDROCHLORIDE — FDA application ANDA090041 — original approval 2015-04-10
LEVONORGESTREL AND ETHINYL ESTRADIOL — FDA application ANDA201095 — original approval 2014-12-08
CALCIUM ACETATE — FDA application ANDA201658 — original approval 2014-10-06
ACYCLOVIR — FDA application ANDA204605 — original approval 2014-06-18
OXYCODONE HYDROCHLORIDE — FDA application ANDA203638 — original approval 2014-06-03
CLOPIDOGREL BISULFATE — FDA application ANDA203751 — original approval 2014-04-11
ATOVAQUONE — FDA application ANDA202960 — original approval 2014-03-18
IBUPROFEN — FDA application ANDA079233 — original approval 2014-03-18
CLINDAMYCIN PALMITATE HYDROCHLORIDE — FDA application ANDA203513 — original approval 2014-03-13
LEVONORGESTREL AND ETHINYL ESTRADIOL — FDA application ANDA201108 — original approval 2014-02-05
NORETHINDRONE — FDA application ANDA202260 — original approval 2013-08-01
METAXALONE — FDA application ANDA203399 — original approval 2013-06-21
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE — FDA application ANDA200894 — original approval 2013-04-24
WARFARIN SODIUM — FDA application ANDA202202 — original approval 2013-03-04
SILDENAFIL CITRATE — FDA application ANDA202025 — original approval 2013-02-28
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE — FDA application ANDA203136 — original approval 2013-02-22
POTASSIUM CHLORIDE — FDA application ANDA202128 — original approval 2013-02-22
OXCARBAZEPINE — FDA application ANDA202961 — original approval 2012-09-17
NORETHINDRONE ACETATE — FDA application ANDA200275 — original approval 2012-07-30
GABAPENTIN — FDA application ANDA202024 — original approval 2012-03-23
ESCITALOPRAM OXALATE — FDA application ANDA202227 — original approval 2012-03-14
IBUPROFEN — FDA application ANDA202300 — original approval 2011-12-23
FELBAMATE — FDA application ANDA202385 — original approval 2011-12-16
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE — FDA application ANDA078892 — original approval 2011-09-26
FELBAMATE — FDA application ANDA201680 — original approval 2011-09-13
RISPERIDONE — FDA application ANDA091384 — original approval 2011-05-25
NITROFURANTOIN — FDA application ANDA201679 — original approval 2011-05-11
MECLIZINE HYDROCHLORIDE — FDA application ANDA201451 — original approval 2011-02-23
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE — FDA application ANDA090575 — original approval 2011-02-08
ONDANSETRON HYDROCHLORIDE — FDA application ANDA091483 — original approval 2011-01-31
INDOMETHACIN — FDA application ANDA091549 — original approval 2010-12-01
SPIRONOLACTONE — FDA application ANDA091426 — original approval 2010-07-02
LORAZEPAM — FDA application ANDA078826 — original approval 2010-06-23
ALBUTEROL SULFATE — FDA application ANDA079241 — original approval 2010-05-12
VENLAFAXINE HYDROCHLORIDE — FDA application ANDA079098 — original approval 2010-05-11
PROMETHAZINE HYDROCHLORIDE — FDA application ANDA040882 — original approval 2009-12-30
LORAZEPAM — FDA application ANDA091383 — original approval 2009-12-23
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN — FDA application ANDA090485 — original approval 2009-12-09
NIZATIDINE — FDA application ANDA090576 — original approval 2009-11-18
LEVETIRACETAM — FDA application ANDA090992 — original approval 2009-10-27
CETIRIZINE HYDROCHLORIDE — FDA application ANDA090766 — original approval 2009-10-07
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY / CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF — FDA application ANDA090765 — original approval 2009-10-07
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE — FDA application ANDA078267 — original approval 2009-09-01
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE — FDA application ANDA040902 — original approval 2009-08-25
PREDNISOLONE SODIUM PHOSPHATE — FDA application ANDA078345 — original approval 2009-03-10
RANITIDINE HYDROCHLORIDE — FDA application ANDA078312 — original approval 2008-09-02
OXYCODONE AND ACETAMINOPHEN — FDA application ANDA040777 — original approval 2007-11-27
BENAZEPRIL HYDROCHLORIDE — FDA application ANDA076820 — original approval 2006-02-03
TRAMADOL HYDROCHLORIDE — FDA application ANDA076003 — original approval 2002-06-20

ANIP — ANI PHARMACEUTICALS INC

NITAZOXANIDE — FDA application ANDA214844 — original approval 2025-02-03
CARBOPROST TROMETHAMINE — FDA application ANDA215901 — original approval 2024-01-25
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE — FDA application ANDA208237 — original approval 2023-12-15
BACLOFEN — FDA application ANDA217252 — original approval 2023-06-08
COLESTIPOL HYDROCHLORIDE — FDA application ANDA216517 — original approval 2023-03-10
FESOTERODINE FUMARATE — FDA application ANDA204504 — original approval 2023-01-04
LEVOTHYROXINE SODIUM — FDA application ANDA213256 — original approval 2021-01-06
AMINOCAPROIC ACID — FDA application ANDA211629 — original approval 2020-12-14
LEVOTHYROXINE SODIUM — FDA application ANDA211369 — original approval 2020-10-28
MEMANTINE HYDROCHLORIDE — FDA application ANDA205365 — original approval 2020-02-28
POTASSIUM CITRATE — FDA application ANDA212779 — original approval 2020-01-14
RANOLAZINE — FDA application ANDA210482 — original approval 2019-10-29
LUXZYLA — FDA application ANDA209921 — original approval 2019-05-07
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE — FDA application ANDA205401 — original approval 2019-01-22
BEXAROTENE — FDA application ANDA209861 — original approval 2018-05-08
FENOFIBRATE (MICRONIZED) — FDA application ANDA209504 — original approval 2018-04-30
MIGLUSTAT — FDA application ANDA208342 — original approval 2018-04-17
MORPHINE SULFATE — FDA application ANDA205509 — original approval 2018-04-17
CYCLOPHOSPHAMIDE — FDA application ANDA207014 — original approval 2018-03-19
OXYCODONE HYDROCHLORIDE — FDA application ANDA203447 — original approval 2017-08-30
METHYLPHENIDATE HYDROCHLORIDE — FDA application ANDA208607 — original approval 2017-07-14
EZETIMIBE AND SIMVASTATIN — FDA application ANDA201890 — original approval 2017-04-26
ASPIRIN AND DIPYRIDAMOLE — FDA application ANDA206964 — original approval 2017-01-18
DESIPRAMINE HYDROCHLORIDE — FDA application ANDA205153 — original approval 2016-10-28
TRANEXAMIC ACID — FDA application ANDA203256 — original approval 2016-07-25
NILUTAMIDE — FDA application ANDA207631 — original approval 2016-07-15
TEMOZOLOMIDE — FDA application ANDA203490 — original approval 2016-07-13
OXYCODONE HYDROCHLORIDE — FDA application ANDA205177 — original approval 2016-03-31
POLYETHYLENE GLYCOL 3350 — FDA application ANDA202850 — original approval 2015-12-15
FELBAMATE — FDA application ANDA202284 — original approval 2015-11-04
OXYCODONE HYDROCHLORIDE — FDA application ANDA204979 — original approval 2015-06-01
NEBIVOLOL HYDROCHLORIDE — FDA application ANDA203659 — original approval 2015-04-16
CARBIDOPA — FDA application ANDA203261 — original approval 2014-03-10
ZOLMITRIPTAN — FDA application ANDA090861 — original approval 2014-03-04
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) — FDA application ANDA200218 — original approval 2013-08-30
ROSIGLITAZONE MALEATE — FDA application ANDA076747 — original approval 2013-01-25
CLOPIDOGREL BISULFATE — FDA application ANDA091216 — original approval 2012-05-17
CLOPIDOGREL BISULFATE — FDA application ANDA090625 — original approval 2012-05-17
TESTOSTERONE — FDA application NDA202763 — original approval 2012-02-14
CARBAMAZEPINE — FDA application ANDA076697 — original approval 2011-05-20
SODIUM POLYSTYRENE SULFONATE — FDA application ANDA090590 — original approval 2011-05-13
FLUCONAZOLE — FDA application ANDA078423 — original approval 2011-03-07
CIPROFLOXACIN EXTENDED RELEASE — FDA application ANDA077809 — original approval 2010-11-30
LANSOPRAZOLE — FDA application ANDA078730 — original approval 2010-10-15
NARATRIPTAN — FDA application ANDA078751 — original approval 2010-07-07
HYDROCODONE BITARTRATE AND IBUPROFEN — FDA application ANDA077454 — original approval 2010-06-23
PERINDOPRIL ERBUMINE — FDA application ANDA078138 — original approval 2009-11-10
RISPERIDONE — FDA application ANDA076440 — original approval 2009-01-30
LACTULOSE — FDA application ANDA090426 — original approval 2008-11-21
FLUOXETINE HYDROCHLORIDE — FDA application ANDA076287 — original approval 2008-05-20
LUVOX — FDA application NDA021519 — original approval 2007-12-20
OXCARBAZEPINE — FDA application ANDA078005 — original approval 2007-12-11
LACTULOSE — FDA application ANDA078430 — original approval 2007-11-28
KIONEX — FDA application ANDA040028 — original approval 2007-09-17
QUINAPRIL HYDROCHLORIDE — FDA application ANDA075504 — original approval 2007-08-24
ALPRAZOLAM — FDA application ANDA077979 — original approval 2007-02-28
LORAZEPAM — FDA application ANDA077396 — original approval 2006-12-13
VEREGEN — FDA application NDA021902 — original approval 2006-10-31
ALPRAZOLAM — FDA application ANDA077725 — original approval 2006-07-31
CEFADROXIL — FDA application ANDA065278 — original approval 2006-01-20
ZONISAMIDE — FDA application ANDA077641 — original approval 2005-12-22
ZONISAMIDE — FDA application ANDA077639 — original approval 2005-12-22
RANITIDINE HYDROCHLORIDE — FDA application ANDA077426 — original approval 2005-12-19
CLARITHROMYCIN — FDA application ANDA065250 — original approval 2005-08-25
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE — FDA application ANDA077144 — original approval 2005-08-16
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE — FDA application ANDA076608 — original approval 2004-12-03
CEFUROXIME AXETIL — FDA application ANDA065190 — original approval 2004-10-18
TIZANIDINE HYDROCHLORIDE — FDA application ANDA076321 — original approval 2004-09-30
FLUCONAZOLE — FDA application ANDA076086 — original approval 2004-07-29
PROPAFENONE HYDROCHLORIDE — FDA application ANDA076550 — original approval 2004-04-23
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — FDA application ANDA076348 — original approval 2004-02-11
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — FDA application ANDA076342 — original approval 2004-02-11
BENAZEPRIL HYDROCHLORIDE — FDA application ANDA076333 — original approval 2004-02-11
METOLAZONE — FDA application ANDA075543 — original approval 2003-12-24
PYRIDOSTIGMINE BROMIDE — FDA application ANDA040512 — original approval 2003-10-08
NEFAZODONE HYDROCHLORIDE — FDA application ANDA076072 — original approval 2003-09-16
EXTENDED PHENYTOIN SODIUM — FDA application ANDA040435 — original approval 2003-06-20
TIZANIDINE HYDROCHLORIDE — FDA application ANDA076371 — original approval 2003-04-09
INNOPRAN XL — FDA application NDA021438 — original approval 2003-03-12
DIFLORASONE DIACETATE — FDA application ANDA076263 — original approval 2002-12-20
FLECAINIDE ACETATE — FDA application ANDA076030 — original approval 2002-10-28
FLECAINIDE ACETATE — FDA application ANDA075882 — original approval 2002-10-28
NIZATIDINE — FDA application ANDA075668 — original approval 2002-09-12
ETODOLAC — FDA application ANDA075943 — original approval 2002-07-26
TIZANIDINE HYDROCHLORIDE — FDA application ANDA076283 — original approval 2002-07-12
MISOPROSTOL — FDA application ANDA076095 — original approval 2002-07-10
NIZATIDINE — FDA application ANDA075461 — original approval 2002-07-08
TIZANIDINE HYDROCHLORIDE — FDA application ANDA076284 — original approval 2002-07-03
CLOBETASOL PROPIONATE (EMOLLIENT) — FDA application ANDA075733 — original approval 2001-08-22
FLUVOXAMINE MALEATE — FDA application ANDA075898 — original approval 2001-03-12
FLUVOXAMINE MALEATE — FDA application ANDA075897 — original approval 2001-01-25
DOXAZOSIN MESYLATE — FDA application ANDA075432 — original approval 2000-10-18
ATACAND HCT — FDA application NDA021093 — original approval 2000-09-05
RANITIDINE HYDROCHLORIDE — FDA application ANDA075296 — original approval 2000-01-14
RANITIDINE HYDROCHLORIDE — FDA application ANDA075212 — original approval 2000-01-14
ETODOLAC — FDA application ANDA075126 — original approval 1999-09-16
PENTOXIFYLLINE — FDA application ANDA075199 — original approval 1999-09-03
LEUCOVORIN CALCIUM — FDA application ANDA075327 — original approval 1999-03-24
INDAPAMIDE — FDA application ANDA075201 — original approval 1998-12-04
ISOSORBIDE MONONITRATE — FDA application ANDA075147 — original approval 1998-11-27
PENTOXIFYLLINE — FDA application ANDA075107 — original approval 1998-09-04
CIMETIDINE HYDROCHLORIDE — FDA application ANDA074859 — original approval 1998-07-09
CIMETIDINE HYDROCHLORIDE — FDA application ANDA075110 — original approval 1998-06-18
ATACAND — FDA application NDA020838 — original approval 1998-06-04
OXYCODONE AND ASPIRIN — FDA application ANDA040255 — original approval 1998-02-27
KIONEX — FDA application ANDA040029 — original approval 1998-02-06
TRIAMTERENE AND HYDROCHLOROTHIAZIDE — FDA application ANDA074970 — original approval 1998-01-06
ETODOLAC — FDA application ANDA074844 — original approval 1997-12-23
ETODOLAC — FDA application ANDA074840 — original approval 1997-08-29
RANITIDINE HYDROCHLORIDE — FDA application ANDA074488 — original approval 1997-07-31
PENTOXIFYLLINE — FDA application ANDA074878 — original approval 1997-07-09
ETODOLAC — FDA application ANDA074899 — original approval 1997-07-08
DESIPRAMINE HYDROCHLORIDE — FDA application ANDA071803 — original approval 1997-05-29
PANDEL — FDA application NDA020453 — original approval 1997-02-28
PROCAINAMIDE HYDROCHLORIDE — FDA application ANDA040111 — original approval 1996-12-13
NICARDIPINE HYDROCHLORIDE — FDA application ANDA074439 — original approval 1996-12-10
INDAPAMIDE — FDA application ANDA074498 — original approval 1996-10-31
NICARDIPINE HYDROCHLORIDE — FDA application ANDA074670 — original approval 1996-10-28
NICARDIPINE HYDROCHLORIDE — FDA application ANDA074540 — original approval 1996-10-28
CHOLESTYRAMINE — FDA application ANDA074554 — original approval 1996-10-02
CIMETIDINE HYDROCHLORIDE — FDA application ANDA074610 — original approval 1996-09-26
DIFLUNISAL — FDA application ANDA074604 — original approval 1996-06-10
MEXILETINE HYDROCHLORIDE — FDA application ANDA074450 — original approval 1996-05-16
GLIPIZIDE — FDA application ANDA074387 — original approval 1996-03-04
TRIAMTERENE AND HYDROCHLOROTHIAZIDE — FDA application ANDA073467 — original approval 1996-01-31
ARIMIDEX — FDA application NDA020541 — original approval 1995-12-27
ACEBUTOLOL HYDROCHLORIDE — FDA application ANDA074007 — original approval 1995-10-18
CASODEX — FDA application NDA020498 — original approval 1995-10-04
GLIPIZIDE — FDA application ANDA074497 — original approval 1995-08-31
INDAPAMIDE — FDA application ANDA074299 — original approval 1995-07-27
CARBIDOPA AND LEVODOPA — FDA application ANDA073587 — original approval 1995-06-29
GUANABENZ ACETATE — FDA application ANDA074149 — original approval 1995-04-07
TRIAMTERENE AND HYDROCHLOROTHIAZIDE — FDA application ANDA074259 — original approval 1995-03-30
TETRACYCLINE HYDROCHLORIDE — FDA application ANDA061471 — original approval 1994-09-16
GUANABENZ ACETATE — FDA application ANDA074267 — original approval 1994-06-01
ALPRAZOLAM — FDA application ANDA074085 — original approval 1994-02-16
METHAZOLAMIDE — FDA application ANDA040001 — original approval 1993-06-30
METOCLOPRAMIDE HYDROCHLORIDE — FDA application ANDA071402 — original approval 1993-06-25
FLUPHENAZINE HYDROCHLORIDE — FDA application ANDA081310 — original approval 1993-04-29
PINDOLOL — FDA application ANDA073609 — original approval 1993-03-29
NORTRIPTYLINE HYDROCHLORIDE — FDA application ANDA074054 — original approval 1992-12-31
OXISTAT — FDA application NDA020209 — original approval 1992-09-30
VALPROIC ACID — FDA application ANDA073178 — original approval 1992-08-25
TOLMETIN SODIUM — FDA application ANDA073527 — original approval 1992-06-30
TOLMETIN SODIUM — FDA application ANDA073519 — original approval 1992-05-29
SULINDAC — FDA application ANDA072973 — original approval 1992-02-28
CLEMASTINE FUMARATE — FDA application ANDA073282 — original approval 1992-01-31
TOLMETIN SODIUM — FDA application ANDA073392 — original approval 1992-01-24
TOLMETIN SODIUM — FDA application ANDA073308 — original approval 1992-01-24
IBUPROFEN — FDA application ANDA072903 — original approval 1991-12-19
IBUPROFEN — FDA application ANDA072901 — original approval 1991-12-19
FLUPHENAZINE HYDROCHLORIDE — FDA application ANDA073058 — original approval 1991-08-30
TIMOLOL MALEATE — FDA application ANDA072919 — original approval 1991-07-31
TIMOLOL MALEATE — FDA application ANDA072918 — original approval 1991-07-31
TIMOLOL MALEATE — FDA application ANDA072917 — original approval 1991-07-31
DIPYRIDAMOLE — FDA application ANDA086944 — original approval 1991-04-16
ERYTHROMYCIN STEARATE — FDA application ANDA063179 — original approval 1990-05-15
PRAZOSIN HYDROCHLORIDE — FDA application ANDA072577 — original approval 1989-04-10
CEFADROXIL — FDA application ANDA062698 — original approval 1989-03-01
FENOPROFEN CALCIUM — FDA application ANDA072274 — original approval 1988-05-02
PROPRANOLOL HYDROCHLORIDE — FDA application ANDA071977 — original approval 1988-04-06
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — FDA application ANDA072043 — original approval 1988-03-14
FUROSEMIDE — FDA application ANDA071594 — original approval 1988-02-09
ISOSORBIDE DINITRATE — FDA application ANDA086032 — original approval 1988-01-07
THIORIDAZINE HYDROCHLORIDE — FDA application ANDA089603 — original approval 1987-11-09
THIORIDAZINE HYDROCHLORIDE — FDA application ANDA089602 — original approval 1987-11-09
PERPHENAZINE — FDA application ANDA089708 — original approval 1987-09-10
PERPHENAZINE — FDA application ANDA089707 — original approval 1987-09-10
PERPHENAZINE — FDA application ANDA089457 — original approval 1987-09-10
PERPHENAZINE — FDA application ANDA089456 — original approval 1987-09-10
PROCAINAMIDE HYDROCHLORIDE — FDA application ANDA089369 — original approval 1987-08-14
PROPRANOLOL HYDROCHLORIDE — FDA application ANDA071791 — original approval 1987-07-15
MECLOFENAMATE SODIUM — FDA application ANDA071469 — original approval 1987-04-15
PROCAINAMIDE HYDROCHLORIDE — FDA application ANDA089438 — original approval 1987-03-23
INDOMETHACIN — FDA application ANDA071149 — original approval 1987-03-18
INDOMETHACIN — FDA application ANDA071148 — original approval 1987-03-18
ACETOHEXAMIDE — FDA application ANDA070870 — original approval 1987-02-09
IBUPROFEN — FDA application ANDA071144 — original approval 1987-01-20
FUROSEMIDE — FDA application ANDA071379 — original approval 1987-01-02
EXTENDED PHENYTOIN SODIUM — FDA application ANDA089441 — original approval 1986-12-18
CHLORPROPAMIDE — FDA application ANDA089447 — original approval 1986-11-17
CHLORPROPAMIDE — FDA application ANDA089446 — original approval 1986-11-17
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — FDA application ANDA070705 — original approval 1986-10-01
PROCAINAMIDE HYDROCHLORIDE — FDA application ANDA089219 — original approval 1986-07-01
FUROSEMIDE — FDA application ANDA070413 — original approval 1986-02-26
DEXCHLORPHENIRAMINE MALEATE — FDA application ANDA088682 — original approval 1986-01-17
MECLIZINE HYDROCHLORIDE — FDA application ANDA088732 — original approval 1985-12-11
PROCAINAMIDE HYDROCHLORIDE — FDA application ANDA088959 — original approval 1985-12-02
PROCAINAMIDE HYDROCHLORIDE — FDA application ANDA088958 — original approval 1985-12-02
SULFAMETHOXAZOLE AND TRIMETHOPRIM — FDA application ANDA070028 — original approval 1985-10-29
PROCAINAMIDE HYDROCHLORIDE — FDA application ANDA088974 — original approval 1985-07-22
THIORIDAZINE HYDROCHLORIDE — FDA application ANDA088493 — original approval 1985-05-17
THIORIDAZINE HYDROCHLORIDE — FDA application ANDA088456 — original approval 1985-05-17
CHLORPROPAMIDE — FDA application ANDA088922 — original approval 1985-04-12
CHLORPROPAMIDE — FDA application ANDA088921 — original approval 1985-04-12
ACETAMINOPHEN AND CODEINE PHOSPHATE — FDA application ANDA088629 — original approval 1985-03-06
CHLORPROPAMIDE — FDA application ANDA088840 — original approval 1984-10-25
CHLORPROPAMIDE — FDA application ANDA088813 — original approval 1984-10-19
CHLORPROPAMIDE — FDA application ANDA088812 — original approval 1984-10-19
CHLORPROPAMIDE — FDA application ANDA088919 — original approval 1984-10-16
CHLORPROPAMIDE — FDA application ANDA088918 — original approval 1984-10-16
CHLORPROPAMIDE — FDA application ANDA088768 — original approval 1984-10-11
GLUCAMIDE — FDA application ANDA088641 — original approval 1984-10-11
CHLORPROPAMIDE — FDA application ANDA088826 — original approval 1984-09-26
CHLORTHALIDONE — FDA application ANDA088164 — original approval 1984-01-09
THIORIDAZINE HYDROCHLORIDE — FDA application ANDA088273 — original approval 1983-10-03
VANCOCIN HYDROCHLORIDE — FDA application ANDA061667 — original approval 1983-07-13
INDERAL LA — FDA application NDA018553 — original approval 1983-04-19
THIORIDAZINE HYDROCHLORIDE — FDA application ANDA088272 — original approval 1983-04-14
THIORIDAZINE HYDROCHLORIDE — FDA application ANDA088271 — original approval 1983-04-14
THIORIDAZINE HYDROCHLORIDE — FDA application ANDA088270 — original approval 1983-04-14
THIORIDAZINE HYDROCHLORIDE — FDA application ANDA088194 — original approval 1983-04-14
QUINIDINE GLUCONATE — FDA application ANDA087810 — original approval 1982-09-29
CHLORTHALIDONE — FDA application ANDA087706 — original approval 1981-09-16
CHLORTHALIDONE — FDA application ANDA087689 — original approval 1981-09-16
CHLORTHALIDONE — FDA application ANDA087296 — original approval 1981-08-19
CHLORPROPAMIDE — FDA application ANDA087353 — original approval 1981-06-26
REGLAN — FDA application NDA017854 — original approval 1980-12-30
ERYTHROMYCIN STEARATE — FDA application ANDA061461 — original approval 1980-04-11
TOLBUTAMIDE — FDA application ANDA087093 — original approval 1980-03-25
OXACILLIN SODIUM — FDA application ANDA062222 — original approval 1980-03-10
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE — FDA application ANDA086727 — original approval 1979-10-29
LITHOBID — FDA application NDA018027 — original approval 1979-04-27
ERYTHROMYCIN ETHYLSUCCINATE — FDA application ANDA062055 — original approval 1978-11-27
PROBENECID AND COLCHICINE — FDA application ANDA083734 — original approval 1978-06-12
PROMPT PHENYTOIN SODIUM — FDA application ANDA080259 — original approval 1978-04-06
MECLIZINE HYDROCHLORIDE — FDA application ANDA085740 — original approval 1977-07-06
METHOCARBAMOL — FDA application ANDA084277 — original approval 1977-03-14
METHOCARBAMOL — FDA application ANDA084276 — original approval 1977-01-04
AMINOPHYLLINE — FDA application ANDA085261 — original approval 1976-12-22
AMITRIPTYLINE HYDROCHLORIDE — FDA application ANDA085032 — original approval 1976-11-19
AMITRIPTYLINE HYDROCHLORIDE — FDA application ANDA085031 — original approval 1976-11-16
MECLIZINE HYDROCHLORIDE — FDA application ANDA085269 — original approval 1976-11-11
BRETHINE — FDA application NDA017849 — original approval 1976-05-17
MECLIZINE HYDROCHLORIDE — FDA application ANDA084657 — original approval 1975-12-01
SULFISOXAZOLE — FDA application ANDA080142 — original approval 1974-03-06
ERYTHROMYCIN STEARATE — FDA application ANDA061591 — original approval 1972-09-08
CORTENEMA — FDA application NDA016199 — original approval 1966-01-12
TENUATE DOSPAN — FDA application NDA012546 — original approval 1960-11-17
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE — FDA application NDA011265 — original approval 1957-12-03
CORTROPHIN-ZINC — FDA application NDA009854 — original approval 1955-07-29
PHENERGAN VC — FDA application NDA008604 — original approval 1954-09-14
PURIFIED CORTROPHIN GEL — FDA application NDA008975 — original approval 1954-06-16
PROMETHAZINE HYDROCHLORIDE PLAIN — FDA application NDA008381 — original approval 1952-04-11
PHENERGAN VC W/ CODEINE / PHENERGAN W/ CODEINE — FDA application NDA008306 — original approval 1952-01-21

ARDX — ARDELYX, INC.

XPHOZAH — FDA application NDA213931 — original approval 2023-10-17
IBSRELA — FDA application NDA211801 — original approval 2019-09-12

BBIO — BridgeBio Pharma, Inc.

ATTRUBY — FDA application NDA216540 — original approval 2024-11-22

BIIB — BIOGEN INC.

ZURZUVAE — FDA application NDA217369 — original approval 2023-08-04
ADUHELM — FDA application BLA761178 — original approval 2021-06-07
VUMERITY — FDA application NDA211855 — original approval 2019-10-29
SPINRAZA — FDA application NDA209531 — original approval 2016-12-23
ZINBRYTA — FDA application BLA761029 — original approval 2016-05-27
TECFIDERA — FDA application NDA204063 — original approval 2013-03-27
AVONEX — FDA application BLA103628 — original approval 1996-05-17

BMY — BRISTOL MYERS SQUIBB CO

OPDIVO QVANTIG — FDA application BLA761429 — original approval 2024-12-27
OPDIVO QVANTIG — FDA application BLA761381 — original approval 2024-12-27
OPDUALAG — FDA application BLA761234 — original approval 2022-03-18
IDHIFA — FDA application NDA209606 — original approval 2017-08-01
EMPLICITI — FDA application BLA761035 — original approval 2015-11-30
DAKLINZA — FDA application NDA206843 — original approval 2015-07-24
OPDIVO — FDA application BLA125527 — original approval 2015-03-04
OPDIVO — FDA application BLA125554 — original approval 2014-12-22
REYATAZ — FDA application NDA206352 — original approval 2014-06-02
ELIQUIS — FDA application NDA202155 — original approval 2012-12-28
NULOJIX — FDA application BLA125288 — original approval 2011-06-15
YERVOY — FDA application BLA125377 — original approval 2011-03-25
SPRYCEL — FDA application NDA022072 — original approval 2006-06-28
SPRYCEL — FDA application NDA021986 — original approval 2006-06-28
REVLIMID — FDA application NDA021880 — original approval 2005-12-27
ORENCIA — FDA application BLA125118 — original approval 2005-12-23
BARACLUDE — FDA application NDA021798 — original approval 2005-03-29
BARACLUDE — FDA application NDA021797 — original approval 2005-03-29
PRAVIGARD PAC (COPACKAGED) — FDA application NDA021387 — original approval 2003-06-24
REYATAZ — FDA application NDA021567 — original approval 2003-06-20
ZERIT XR — FDA application NDA021453 — original approval 2002-12-31
METAGLIP — FDA application NDA021460 — original approval 2002-10-21
SUSTIVA — FDA application NDA021360 — original approval 2002-02-01
BUSPAR — FDA application NDA021190 — original approval 2000-12-20
VIDEX EC — FDA application NDA021183 — original approval 2000-10-31
GLUCOVANCE — FDA application NDA021178 — original approval 2000-07-31
SUSTIVA — FDA application NDA020972 — original approval 1998-09-17
ETOPOPHOS PRESERVATIVE FREE — FDA application NDA020906 — original approval 1998-02-27
SERZONE — FDA application NDA020152 — original approval 1994-12-22
MONOPRIL-HCT — FDA application NDA020286 — original approval 1994-11-30
MEGACE — FDA application NDA020264 — original approval 1993-09-10
ESTRACE — FDA application ANDA081295 — original approval 1993-06-30
STADOL — FDA application NDA019890 — original approval 1991-12-12
PRAVACHOL — FDA application NDA019898 — original approval 1991-10-31
VIDEX — FDA application NDA020155 — original approval 1991-10-09
VIDEX — FDA application NDA020154 — original approval 1991-10-09
MONOPRIL — FDA application NDA019915 — original approval 1991-05-16
AZACTAM IN PLASTIC CONTAINER — FDA application NDA050632 — original approval 1989-05-24
MEXATE-AQ PRESERVED — FDA application ANDA089887 — original approval 1989-04-14
RUBEX — FDA application ANDA062926 — original approval 1989-04-13
NARCAN — FDA application ANDA071311 — original approval 1988-07-28
NARCAN — FDA application ANDA071084 — original approval 1988-07-28
NARCAN — FDA application ANDA071083 — original approval 1988-07-28
VINCREX — FDA application ANDA070867 — original approval 1988-07-12
BUSPAR — FDA application NDA018731 — original approval 1986-09-29
AMITID — FDA application ANDA086454 — original approval 1978-10-19
GLUCOSCAN — FDA application NDA017907 — original approval 1978-05-25
OXYCODONE 5/APAP 500 — FDA application ANDA085911 — original approval 1977-10-25
OXYCODONE 2.5/APAP 500 — FDA application ANDA085910 — original approval 1977-10-25
ESTRACE — FDA application ANDA084499 — original approval 1975-07-28
ESTRACE — FDA application ANDA084500 — original approval 1975-07-23
BLENOXANE — FDA application NDA050443 — original approval 1973-07-31
PROLIXIN DECANOATE — FDA application NDA016727 — original approval 1972-06-20
MEGACE — FDA application NDA016979 — original approval 1971-08-18
FUNGIZONE — FDA application NDA050341 — original approval 1971-06-02
PRINCIPEN — FDA application ANDA061392 — original approval 1971-03-03
TESLAC — FDA application NDA016118 — original approval 1970-05-27
TESLAC — FDA application NDA016119 — original approval 1969-06-03
VESPRIN — FDA application NDA011123 — original approval 1957-09-16
COUMADIN — FDA application NDA009218 — original approval 1954-06-08
RUBRAMIN PC — FDA application NDA006799 — original approval 1950-09-29
TUBOCURARINE CHLORIDE — FDA application NDA005657 — original approval 1945-02-20

CPRX — CATALYST PHARMACEUTICALS, INC.

AGAMREE — FDA application NDA215239 — original approval 2023-10-26
FIRDAPSE — FDA application NDA208078 — original approval 2018-11-28
FYCOMPA — FDA application NDA208277 — original approval 2016-04-29
FYCOMPA — FDA application NDA202834 — original approval 2012-10-22

CRMD — CorMedix Inc.

DEFENCATH — FDA application NDA214520 — original approval 2023-11-15

CYTK — CYTOKINETICS INC

MYQORZO — FDA application NDA219083 — original approval 2025-12-19

DNLI — Denali Therapeutics Inc.

AVLAYAH — FDA application BLA761485 — original approval 2026-03-24

EOLS — Evolus, Inc.

JEUVEAU — FDA application BLA761085 — original approval 2019-02-01

EXEL — EXELIXIS, INC.

CABOMETYX — FDA application NDA208692 — original approval 2016-04-25
COMETRIQ — FDA application NDA203756 — original approval 2012-11-29

FENC — FENNEC PHARMACEUTICALS INC.

PEDMARK — FDA application NDA212937 — original approval 2022-09-20

GERN — GERON CORP

RYTELO — FDA application NDA217779 — original approval 2024-06-06

GILD — GILEAD SCIENCES, INC.

HEPCLUDEX — FDA application BLA761468 — original approval 2026-05-22
YEZTUGO — FDA application NDA220020 — original approval 2025-06-18
YEZTUGO — FDA application NDA220018 — original approval 2025-06-18
LIVDELZI — FDA application NDA217899 — original approval 2024-08-14
SUNLENCA — FDA application NDA215974 — original approval 2022-12-22
SUNLENCA — FDA application NDA215973 — original approval 2022-12-22
EPCLUSA — FDA application NDA214187 — original approval 2021-06-10
VEKLURY — FDA application NDA214787 — original approval 2020-10-22
SOVALDI — FDA application NDA212480 — original approval 2019-08-28
HARVONI — FDA application NDA212477 — original approval 2019-08-28
BIKTARVY — FDA application NDA210251 — original approval 2018-02-07
VOSEVI — FDA application NDA209195 — original approval 2017-07-18
VEMLIDY — FDA application NDA208464 — original approval 2016-11-10
EPCLUSA — FDA application NDA208341 — original approval 2016-06-28
DESCOVY — FDA application NDA208215 — original approval 2016-04-04
ODEFSEY — FDA application NDA208351 — original approval 2016-03-01
GENVOYA — FDA application NDA207561 — original approval 2015-11-05
HARVONI — FDA application NDA205834 — original approval 2014-10-10
TYBOST — FDA application NDA203094 — original approval 2014-09-24
VITEKTA — FDA application NDA203093 — original approval 2014-09-24
ZYDELIG — FDA application NDA206545 — original approval 2014-07-23
ZYDELIG — FDA application NDA205858 — original approval 2014-07-23
SOVALDI — FDA application NDA204671 — original approval 2013-12-06
STRIBILD — FDA application NDA203100 — original approval 2012-08-27
VIREAD — FDA application NDA022577 — original approval 2012-01-18
COMPLERA — FDA application NDA202123 — original approval 2011-08-10
ATRIPLA — FDA application NDA021937 — original approval 2006-07-12
VIREAD — FDA application NDA021356 — original approval 2001-10-26
VISTIDE — FDA application NDA020638 — original approval 1996-06-26

INCY — INCYTE CORP

JAKAFI XR — FDA application NDA217180 — original approval 2026-05-01
NIKTIMVO — FDA application BLA761411 — original approval 2024-08-14
ZYNYZ — FDA application BLA761334 — original approval 2023-03-22
OPZELURA — FDA application NDA215309 — original approval 2021-09-21
PEMAZYRE — FDA application NDA213736 — original approval 2020-04-17
JAKAFI — FDA application NDA202192 — original approval 2011-11-16

INSM — INSMED Inc

BRINSUPRI — FDA application NDA217673 — original approval 2025-08-12
ARIKAYCE KIT — FDA application NDA207356 — original approval 2018-09-28
IPLEX — FDA application BLA021884 — original approval 2005-12-12

IONS — IONIS PHARMACEUTICALS INC

DAWNZERA (AUTOINJECTOR) — FDA application NDA219407 — original approval 2025-08-21
TRYNGOLZA (AUTOINJECTOR) — FDA application NDA218614 — original approval 2024-12-19

IRWD — IRONWOOD PHARMACEUTICALS INC

DUZALLO — FDA application NDA209203 — original approval 2017-08-18
ZURAMPIC — FDA application NDA207988 — original approval 2015-12-22

JAZZ — Jazz Pharmaceuticals plc

ZIIHERA — FDA application BLA761416 — original approval 2024-11-20
RYLAZE — FDA application BLA761179 — original approval 2021-06-30
DEFITELIO — FDA application NDA208114 — original approval 2016-03-30
LUVOX CR — FDA application NDA022033 — original approval 2008-02-28
XYREM — FDA application NDA021196 — original approval 2002-07-17

JNJ — JOHNSON & JOHNSON

VASCOR — FDA application NDA019002 — original approval 1990-12-28
ERYCETTE — FDA application NDA050594 — original approval 1985-02-15
GRIFULVIN V — FDA application NDA050448 — original approval 1972-05-30

LGND — LIGAND PHARMACEUTICALS INC

SITAVIG — FDA application NDA203791 — original approval 2013-04-12

LLY — ELI LILLY & Co

FOUNDAYO — FDA application NDA220934 — original approval 2026-04-01
INLURIYO — FDA application NDA218881 — original approval 2025-09-25
EBGLYSS — FDA application BLA761306 — original approval 2024-09-13
KISUNLA — FDA application BLA761248 — original approval 2024-07-02
RETEVMO — FDA application NDA218160 — original approval 2024-04-10
ZEPBOUND / ZEPBOUND (AUTOINJECTOR) / ZEPBOUND KWIKPEN — FDA application NDA217806 — original approval 2023-11-08
OMVOH — FDA application BLA761279 — original approval 2023-10-26
MOUNJARO / MOUNJARO (AUTOINJECTOR) / MOUNJARO KWIKPEN — FDA application NDA215866 — original approval 2022-05-13
LYUMJEV — FDA application BLA761109 — original approval 2020-06-15
RETEVMO — FDA application NDA213246 — original approval 2020-05-08
REYVOW — FDA application NDA211280 — original approval 2019-10-11
EMGALITY — FDA application BLA761063 — original approval 2018-09-27
OLUMIANT — FDA application NDA207924 — original approval 2018-05-31
VERZENIO — FDA application NDA208855 — original approval 2018-02-26
VERZENIO — FDA application NDA208716 — original approval 2017-09-28
LARTRUVO — FDA application BLA761038 — original approval 2016-10-19
TALTZ — FDA application BLA125521 — original approval 2016-03-22
BASAGLAR — FDA application BLA205692 — original approval 2015-12-16
PORTRAZZA — FDA application BLA125547 — original approval 2015-11-24
HUMALOG KWIKPEN — FDA application BLA205747 — original approval 2015-05-26
TRULICITY — FDA application BLA125469 — original approval 2014-09-18
CYRAMZA — FDA application BLA125477 — original approval 2014-04-21
AXIRON — FDA application NDA022504 — original approval 2010-11-23
ADCIRCA — FDA application NDA022332 — original approval 2009-05-22
PROZAC / SARAFEM — FDA application NDA018936 — original approval 1987-12-29

LNTH — Lantheus Holdings, Inc.

NEURACEQ — FDA application NDA204677 — original approval 2014-03-19

MNKD — MANNKIND CORP

AFREZZA — FDA application BLA022472 — original approval 2014-06-27

MRK — Merck & Co., Inc.

EMEND — FDA application NDA022023 — original approval 2008-01-25
VIOXX — FDA application NDA021647 — original approval 2004-03-26
FOSAMAX — FDA application NDA021575 — original approval 2003-09-17
CANCIDAS — FDA application NDA021227 — original approval 2001-01-26
VIOXX — FDA application NDA021052 — original approval 1999-05-20
VIOXX — FDA application NDA021042 — original approval 1999-05-20
PEPCID RPD — FDA application NDA020752 — original approval 1998-05-28
TIAMATE — FDA application NDA020506 — original approval 1996-10-04
CHIBROXIN — FDA application NDA019757 — original approval 1991-06-17
PRIMAXIN — FDA application NDA050630 — original approval 1990-12-14
PRINZIDE — FDA application NDA019778 — original approval 1989-02-16
PRINIVIL — FDA application NDA019558 — original approval 1987-12-29
MEVACOR — FDA application NDA019643 — original approval 1987-08-31
PRIMAXIN — FDA application ANDA062756 — original approval 1987-01-08
PEPCID / PEPCID PRESERVATIVE FREE — FDA application NDA019510 — original approval 1986-11-04
NOROXIN — FDA application NDA019384 — original approval 1986-10-31
PRIMAXIN — FDA application NDA050587 — original approval 1985-11-26
DOLOBID — FDA application NDA018445 — original approval 1982-04-19
TIMOLIDE 10-25 — FDA application NDA018061 — original approval 1981-12-11
BLOCADREN — FDA application NDA018017 — original approval 1981-11-25
MODURETIC 5-50 — FDA application NDA018201 — original approval 1981-10-05
ALDOMET — FDA application NDA018389 — original approval 1981-08-28
CLINORIL — FDA application NDA017911 — original approval 1978-09-27
ELSPAR — FDA application BLA101063 — original approval 1978-01-10
ALPHAREDISOL — FDA application ANDA080778 — original approval 1975-04-18
HYDROPRES 25 / HYDROPRES 50 — FDA application NDA011958 — original approval 1974-05-16
DECADRON-LA — FDA application NDA016675 — original approval 1973-09-06
NEODECADRON — FDA application NDA050324 — original approval 1969-09-15
NEODECADRON — FDA application NDA050322 — original approval 1969-07-02
ALDOCLOR-150 / ALDOCLOR-250 — FDA application NDA016016 — original approval 1968-03-20
ALDORIL 15 / ALDORIL 25 / ALDORIL D30 / ALDORIL D50 — FDA application NDA013402 — original approval 1962-12-20
ALDOMET — FDA application NDA013401 — original approval 1962-12-20
ALDOMET — FDA application NDA013400 — original approval 1962-12-20
DECADRON W/ XYLOCAINE — FDA application NDA013334 — original approval 1962-07-11
PERIACTIN — FDA application NDA013220 — original approval 1962-03-30
PERIACTIN — FDA application NDA012649 — original approval 1961-10-17
COLBENEMID — FDA application NDA012383 — original approval 1961-07-27
DECASPRAY — FDA application NDA012731 — original approval 1961-03-29
DECADRON — FDA application NDA012376 — original approval 1960-07-07
HYDROCORTONE — FDA application NDA012052 — original approval 1960-06-08
DECADRON — FDA application NDA012071 — original approval 1959-10-06
DECADRON — FDA application NDA011984 — original approval 1959-09-02
DECADRON — FDA application NDA011977 — original approval 1959-09-02
DECADRON — FDA application NDA011983 — original approval 1959-08-26
HUMORSOL — FDA application NDA011860 — original approval 1959-08-05
HYDRODIURIL — FDA application NDA011835 — original approval 1959-02-24
DIUPRES-250 / DIUPRES-500 — FDA application NDA011635 — original approval 1958-12-11
DECADRON — FDA application NDA011664 — original approval 1958-10-30
LERITINE — FDA application NDA010585 — original approval 1957-08-15
FLOROPRYL — FDA application NDA010656 — original approval 1957-04-02
HYDELTRA-TBA — FDA application NDA010562 — original approval 1956-07-25
ARAMINE — FDA application NDA009509 — original approval 1954-09-29
COGENTIN — FDA application NDA009193 — original approval 1954-03-05
HYDROCORTONE — FDA application NDA008506 — original approval 1952-08-05
HYDROCORTONE — FDA application NDA008228 — original approval 1951-12-21
BENEMID — FDA application NDA007898 — original approval 1951-04-26
CORTONE — FDA application NDA007750 — original approval 1950-12-04
CORTONE — FDA application NDA007110 — original approval 1950-06-13
AMINOHIPPURATE SODIUM — FDA application NDA005619 — original approval 1944-12-30

NUVL — Nuvalent, Inc.

JIDEYTRO — FDA application NDA220185 — original approval 2026-07-22

OCUL — OCULAR THERAPEUTIX, INC

DEXTENZA — FDA application NDA208742 — original approval 2018-11-30

OGN — Organon & Co.

VTAMA — FDA application NDA215272 — original approval 2022-05-23
XACIATO — FDA application NDA215650 — original approval 2021-12-07
ASMANEX HFA — FDA application NDA205641 — original approval 2014-04-25
LIPTRUZET — FDA application NDA200153 — original approval 2013-05-03
DULERA — FDA application NDA022518 — original approval 2010-06-22
IMPLANON / NEXPLANON — FDA application NDA021529 — original approval 2006-07-17
CLARINEX-D 12 HOUR — FDA application NDA021313 — original approval 2006-02-01
FOSAMAX PLUS D — FDA application NDA021762 — original approval 2005-04-07
ASMANEX TWISTHALER — FDA application NDA021067 — original approval 2005-03-30
CLARINEX D 24 HOUR — FDA application NDA021605 — original approval 2005-03-03
CLARINEX — FDA application NDA021300 — original approval 2004-09-01
VYTORIN — FDA application NDA021687 — original approval 2004-07-23
ZETIA — FDA application NDA021445 — original approval 2002-10-25
SINGULAIR — FDA application NDA021409 — original approval 2002-07-26
CLARINEX — FDA application NDA021312 — original approval 2002-06-26
CLARINEX — FDA application NDA021165 — original approval 2001-12-21
MAXALT-MLT — FDA application NDA020865 — original approval 1998-06-29
MAXALT — FDA application NDA020864 — original approval 1998-06-29
SINGULAIR — FDA application NDA020830 — original approval 1998-02-20
SINGULAIR — FDA application NDA020829 — original approval 1998-02-20
PROPECIA — FDA application NDA020788 — original approval 1997-12-19
NASONEX — FDA application NDA020762 — original approval 1997-10-01
REMERON — FDA application NDA020415 — original approval 1996-06-14
FOSAMAX — FDA application NDA020560 — original approval 1995-09-29
HYZAAR — FDA application NDA020387 — original approval 1995-04-28
COZAAR — FDA application NDA020386 — original approval 1995-04-14
PROSCAR — FDA application NDA020180 — original approval 1992-06-19
ZOCOR — FDA application NDA019766 — original approval 1991-12-23
SINEMET CR — FDA application NDA019856 — original approval 1991-05-30
ELOCON — FDA application NDA019796 — original approval 1989-03-30
DIPROLENE — FDA application NDA019716 — original approval 1988-08-01
ELOCON — FDA application NDA019625 — original approval 1987-05-06
ELOCON — FDA application NDA019543 — original approval 1987-04-30
DIPROLENE AF — FDA application NDA019555 — original approval 1987-04-27
LOTRISONE — FDA application NDA018827 — original approval 1984-07-10
DIPROLENE — FDA application NDA018741 — original approval 1983-07-27
SINEMET — FDA application NDA017555 — original approval 1975-05-02
CELESTONE SOLUSPAN — FDA application NDA014602 — original approval 1965-03-03

OMER — OMEROS CORP

YARTEMLEA — FDA application BLA761152 — original approval 2025-12-23

PFE — PFIZER INC

HYMPAVZI — FDA application BLA761369 — original approval 2024-10-11
TALZENNA — FDA application NDA217439 — original approval 2024-03-07
VELSIPITY — FDA application NDA216956 — original approval 2023-10-12
ELREXFIO — FDA application BLA761345 — original approval 2023-08-14
LITFULO — FDA application NDA215830 — original approval 2023-06-23
PAXLOVID (COPACKAGED) — FDA application NDA217188 — original approval 2023-05-25
ZAVZPRET — FDA application NDA216386 — original approval 2023-03-09
CIBINQO — FDA application NDA213871 — original approval 2022-01-14
XELJANZ — FDA application NDA213082 — original approval 2020-09-25
NURTEC ODT — FDA application NDA212728 — original approval 2020-02-27
ABRILADA — FDA application BLA761118 — original approval 2019-11-15
IBRANCE — FDA application NDA212436 — original approval 2019-11-01
RUXIENCE — FDA application BLA761103 — original approval 2019-07-23
ZIRABEV — FDA application BLA761099 — original approval 2019-06-27
TRAZIMERA — FDA application BLA761081 — original approval 2019-03-11
DAURISMO — FDA application NDA210656 — original approval 2018-11-21
LORBRENA — FDA application NDA210868 — original approval 2018-11-02
TALZENNA — FDA application NDA211651 — original approval 2018-10-16
VIZIMPRO — FDA application NDA211288 — original approval 2018-09-27
IXIFI — FDA application BLA761072 — original approval 2017-12-13
TROXYCA ER — FDA application NDA207621 — original approval 2016-08-19
XELJANZ XR — FDA application NDA208246 — original approval 2016-02-23
IBRANCE — FDA application NDA207103 — original approval 2015-02-03
ELELYSO — FDA application BLA022458 — original approval 2012-05-01
HEPARIN SODIUM / HEPARIN SODIUM PRESERVATIVE FREE — FDA application NDA201370 — original approval 2011-07-21
TOVIAZ — FDA application NDA022030 — original approval 2008-10-31
GEODON — FDA application NDA021483 — original approval 2006-03-29
ERAXIS — FDA application NDA021948 — original approval 2006-02-17
DEPO-SUBQ PROVERA 104 — FDA application NDA021583 — original approval 2004-12-17
VFEND — FDA application NDA021466 — original approval 2003-11-14
VFEND — FDA application NDA021464 — original approval 2003-11-14
DAYPRO ALTA — FDA application NDA020776 — original approval 2002-10-17
CAVERJECT IMPULSE — FDA application NDA021212 — original approval 2002-06-11
ZITHROMAX — FDA application NDA050784 — original approval 2002-05-24
ZYVOX — FDA application NDA021132 — original approval 2000-04-18
ZYVOX — FDA application NDA021131 — original approval 2000-04-18
ZYVOX — FDA application NDA021130 — original approval 2000-04-18
AROMASIN — FDA application NDA020753 — original approval 1999-10-21
TIKOSYN — FDA application NDA020931 — original approval 1999-10-01
ELLENCE — FDA application NDA050778 — original approval 1999-09-15
CLEOCIN — FDA application NDA050767 — original approval 1999-08-13
SONATA — FDA application NDA020859 — original approval 1999-08-13
TROVAN/ZITHROMAX COMPLIANCE PAK — FDA application NDA050762 — original approval 1998-12-18
STERANE — FDA application NDA011446 — original approval 1998-05-12
ARTHROTEC — FDA application NDA020607 — original approval 1997-12-24
TROVAN PRESERVATIVE FREE — FDA application NDA020760 — original approval 1997-12-18
TROVAN — FDA application NDA020759 — original approval 1997-12-18
FLAGYL ER — FDA application NDA020868 — original approval 1997-11-26
CAVERJECT — FDA application NDA020755 — original approval 1997-10-31
NICOTROL — FDA application NDA020714 — original approval 1997-05-02
IDAMYCIN PFS / IDARUBICIN HYDROCHLORIDE — FDA application NDA050734 — original approval 1997-02-17
ZITHROMAX — FDA application NDA050733 — original approval 1997-01-30
DOSTINEX — FDA application NDA020664 — original approval 1996-12-23
GLYSET — FDA application NDA020682 — original approval 1996-12-18
ZITHROMAX — FDA application NDA050711 — original approval 1996-07-18
MERREM IV — FDA application NDA050706 — original approval 1996-06-21
CAMPTOSAR — FDA application NDA020571 — original approval 1996-06-14
ZITHROMAX — FDA application NDA050730 — original approval 1996-06-12
ESTRING — FDA application NDA020472 — original approval 1996-04-26
NICOTROL — FDA application NDA020385 — original approval 1996-03-22
COVERA-HS — FDA application NDA020552 — original approval 1996-02-26
CORVERT — FDA application NDA020491 — original approval 1995-12-28
ZITHROMAX — FDA application NDA050710 — original approval 1995-10-19
CAVERJECT — FDA application NDA020379 — original approval 1995-07-06
ZINECARD — FDA application NDA020212 — original approval 1995-05-26
FLAGYL — FDA application NDA020334 — original approval 1995-05-03
CEFOBID — FDA application ANDA063333 — original approval 1995-03-31
FRAGMIN — FDA application NDA020287 — original approval 1994-12-22
ZITHROMAX — FDA application NDA050693 — original approval 1994-09-28
COLESTID — FDA application NDA020222 — original approval 1994-07-19
GLUCOTROL XL — FDA application NDA020329 — original approval 1994-04-26
DIFLUCAN — FDA application NDA020090 — original approval 1993-12-23
MYCOBUTIN — FDA application NDA050689 — original approval 1992-12-23
PREPIDIL — FDA application NDA019617 — original approval 1992-12-09
DEPO-PROVERA — FDA application NDA020246 — original approval 1992-10-29
DAYPRO — FDA application NDA018841 — original approval 1992-10-29
CLEOCIN — FDA application NDA050680 — original approval 1992-08-11
VANTIN — FDA application NDA050675 — original approval 1992-08-07
VANTIN — FDA application NDA050674 — original approval 1992-08-07
GLYNASE — FDA application NDA020051 — original approval 1992-03-04
MINIPRESS XL — FDA application NDA019775 — original approval 1992-01-29
ZITHROMAX — FDA application NDA050670 — original approval 1991-11-01
ADRIAMYCIN PFS — FDA application ANDA063165 — original approval 1991-01-30
IDAMYCIN — FDA application NDA050661 — original approval 1990-09-27
SYNAREL — FDA application NDA019886 — original approval 1990-02-13
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER / DIFLUCAN IN SODIUM CHLORIDE 0.9% / DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER — FDA application NDA019950 — original approval 1990-01-29
DIFLUCAN — FDA application NDA019949 — original approval 1990-01-29
PROCARDIA XL — FDA application NDA019684 — original approval 1989-09-06
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER — FDA application NDA050639 — original approval 1989-08-30
CLEOCIN T — FDA application NDA050600 — original approval 1989-05-31
CYTOTEC — FDA application NDA019268 — original approval 1988-12-27
UNASYN — FDA application ANDA062901 — original approval 1988-11-25
DOXORUBICIN HYDROCHLORIDE — FDA application NDA050629 — original approval 1987-12-23
CLEOCIN PHOSPHATE — FDA application ANDA062803 — original approval 1987-10-16
CLEOCIN T — FDA application NDA050615 — original approval 1987-01-07
UNASYN — FDA application NDA050608 — original approval 1986-12-31
CYKLOKAPRON — FDA application NDA019281 — original approval 1986-12-30
CALAN SR — FDA application NDA019152 — original approval 1986-12-16
CEFOBID IN PLASTIC CONTAINER — FDA application NDA050613 — original approval 1986-07-23
NORQUEST FE — FDA application NDA018926 — original approval 1986-07-18
CLEOCIN — FDA application ANDA062644 — original approval 1986-04-07
PSORCON — FDA application NDA019260 — original approval 1985-08-28
FLORONE E — FDA application NDA019259 — original approval 1985-08-28
CALAN — FDA application NDA018817 — original approval 1984-09-10
GLUCOTROL — FDA application NDA017783 — original approval 1984-05-08
MICRONASE — FDA application NDA017498 — original approval 1984-05-01
TZ-3 — FDA application NDA018682 — original approval 1983-02-18
CEFOBID — FDA application NDA050551 — original approval 1982-11-18
HALCION — FDA application NDA017892 — original approval 1982-11-15
NORPACE CR — FDA application NDA018655 — original approval 1982-07-20
FELDENE — FDA application NDA018147 — original approval 1982-04-06
SPECTROBID — FDA application NDA050556 — original approval 1982-03-23
PROCARDIA — FDA application NDA018482 — original approval 1981-12-31
PROSTIN VR PEDIATRIC — FDA application NDA018484 — original approval 1981-10-16
SPECTROBID — FDA application NDA050520 — original approval 1980-12-22
FLAGYL I.V. / FLAGYL I.V. RTU IN PLASTIC CONTAINER — FDA application NDA018353 — original approval 1980-11-28
VANSIL — FDA application NDA018069 — original approval 1980-07-23
CLEOCIN / CLEOCIN T — FDA application NDA050537 — original approval 1980-07-09
MINIZIDE — FDA application NDA017986 — original approval 1980-06-13
VIBRA-TABS — FDA application NDA050533 — original approval 1980-01-15
LONITEN — FDA application NDA018154 — original approval 1979-10-18
DEPO-ESTRADIOL — FDA application ANDA085470 — original approval 1979-08-15
DEPO-TESTOSTERONE — FDA application ANDA085635 — original approval 1979-07-25
HEMABATE — FDA application NDA017989 — original approval 1979-01-09
PSORCON E — FDA application NDA017994 — original approval 1978-03-01
PFIZERPEN-A — FDA application ANDA062049 — original approval 1977-12-02
FLORONE — FDA application NDA017741 — original approval 1977-09-14
NORPACE — FDA application NDA017447 — original approval 1977-09-01
PROSTIN E2 — FDA application NDA017810 — original approval 1977-08-23
PFIZERPEN-A — FDA application ANDA062050 — original approval 1977-07-05
OGEN .625 / OGEN 1.25 / OGEN 2.5 / OGEN 5 — FDA application ANDA083220 — original approval 1977-05-19
COLESTID / FLAVORED COLESTID — FDA application NDA017563 — original approval 1977-04-04
MINIPRESS — FDA application NDA017442 — original approval 1976-06-23
PFIZERPEN VK — FDA application ANDA061815 — original approval 1974-11-14
VIBRAMYCIN — FDA application NDA050480 — original approval 1974-09-23
PFIZERPEN VK — FDA application ANDA061836 — original approval 1974-08-09
DOXORUBICIN HYDROCHLORIDE — FDA application NDA050467 — original approval 1974-08-07
EMETE-CON — FDA application NDA016820 — original approval 1974-03-12
SINEQUAN — FDA application NDA017516 — original approval 1974-03-11
GEOCILLIN — FDA application NDA050435 — original approval 1972-10-26
CLEOCIN PHOSPHATE — FDA application NDA050441 — original approval 1972-10-02
VIBRAMYCIN — FDA application NDA050442 — original approval 1972-09-05
NAVANE — FDA application NDA016904 — original approval 1971-08-19
TROBICIN — FDA application NDA050347 — original approval 1971-06-30
MITHRACIN — FDA application NDA050109 — original approval 1970-05-05
LITHIUM CARBONATE — FDA application NDA016834 — original approval 1970-04-06
NAVANE — FDA application NDA016758 — original approval 1970-04-06
CLEOCIN HYDROCHLORIDE — FDA application NDA050162 — original approval 1970-02-22
SINEQUAN — FDA application NDA016798 — original approval 1969-09-23
TERRA-CORTRIL — FDA application ANDA061016 — original approval 1969-09-18
TAO — FDA application NDA050336 — original approval 1969-05-27
VISTARIL — FDA application NDA011459 — original approval 1968-11-15
PFIZERPEN — FDA application ANDA060657 — original approval 1968-08-30
VIBRAMYCIN — FDA application NDA050006 — original approval 1967-12-06
VIBRAMYCIN — FDA application NDA050007 — original approval 1967-12-05
NAVANE — FDA application NDA016584 — original approval 1967-07-24
LINCOCIN — FDA application NDA050317 — original approval 1964-12-29
TERRAMYCIN — FDA application ANDA060567 — original approval 1964-09-15
TERRAMYCIN — FDA application NDA050286 — original approval 1964-09-08
RENESE-R — FDA application NDA013636 — original approval 1963-10-15
FLAGYL — FDA application NDA012623 — original approval 1963-07-18
RENESE — FDA application NDA012845 — original approval 1961-09-26
ALDACTAZIDE — FDA application NDA012616 — original approval 1961-01-27
DIDREX — FDA application NDA012427 — original approval 1960-10-26
DEPO-PROVERA — FDA application NDA012541 — original approval 1960-09-23
LOMOTIL — FDA application NDA012462 — original approval 1960-09-15
ALDACTONE — FDA application NDA012151 — original approval 1960-01-21
PROVERA — FDA application NDA011839 — original approval 1959-06-18
VISTARIL — FDA application NDA011795 — original approval 1959-06-03
DEPO-MEDROL — FDA application NDA011757 — original approval 1959-05-27
DIABINESE — FDA application NDA011641 — original approval 1958-10-28
TESSALON — FDA application NDA011210 — original approval 1958-02-10
MEDROL — FDA application NDA011153 — original approval 1957-10-24
VISTARIL — FDA application NDA011111 — original approval 1957-09-18
MODERIL — FDA application NDA010686 — original approval 1956-10-31
MAGNACORT — FDA application NDA010554 — original approval 1956-10-15
ATARAX — FDA application NDA010392 — original approval 1956-04-12
STERANE — FDA application NDA009996 — original approval 1955-07-01
TETRACYN — FDA application ANDA060285 — original approval 1954-01-04
CORTRIL — FDA application NDA009127 — original approval 1953-12-03
STREPTOMYCIN SULFATE — FDA application ANDA060111 — original approval 1952-02-12
PFIZERPEN G — FDA application ANDA060587 — original approval 1951-09-13
PFIZERPEN-AS — FDA application ANDA060286 — original approval 1950-11-01
AZULFIDINE / AZULFIDINE EN-TABS — FDA application NDA007073 — original approval 1950-06-20
PENICILLIN G PROCAINE — FDA application ANDA060099 — original approval 1948-11-10
PFIZERPEN G — FDA application ANDA060075 — original approval 1948-03-02
PENICILLIN G POTASSIUM — FDA application ANDA060074 — original approval 1947-02-06
STREPTOMYCIN SULFATE — FDA application ANDA060076 — original approval 1946-02-18

PHAT — Phathom Pharmaceuticals, Inc.

VOQUEZNA — FDA application NDA218710 — original approval 2024-07-17

PRGO — PERRIGO Co plc

DESLORATADINE — FDA application ANDA078361 — original approval 2011-12-22
FAMOTIDINE — FDA application ANDA075400 — original approval 2005-03-18
LORATADINE — FDA application ANDA075728 — original approval 2004-08-20
LORATADINE — FDA application ANDA076301 — original approval 2004-06-25
LORATADINE — FDA application NDA021512 — original approval 2004-06-24
MICONAZOLE 3 COMBINATION PACK — FDA application ANDA076357 — original approval 2004-03-30
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE — FDA application ANDA076518 — original approval 2004-03-17
IBUPROFEN — FDA application ANDA076359 — original approval 2004-01-16
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE — FDA application ANDA076478 — original approval 2003-11-05
FAMOTIDINE — FDA application ANDA075715 — original approval 2003-08-22
RANITIDINE HYDROCHLORIDE — FDA application ANDA076195 — original approval 2002-08-30
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE — FDA application ANDA076029 — original approval 2002-08-30
IBUPROFEN — FDA application ANDA075995 — original approval 2002-03-14
KETOPROFEN — FDA application ANDA075364 — original approval 2002-02-07
CROMOLYN SODIUM — FDA application ANDA075427 — original approval 2001-12-12
ACETAMINOPHEN, ASPIRIN AND CAFFEINE — FDA application ANDA075794 — original approval 2001-11-26
TIOCONAZOLE — FDA application ANDA075915 — original approval 2001-11-21
MINOXIDIL EXTRA STRENGTH (FOR MEN) — FDA application ANDA075598 — original approval 2001-06-13
ACETAMINOPHEN — FDA application ANDA075077 — original approval 2000-02-25
CHILDREN'S IBUPROFEN — FDA application ANDA074937 — original approval 1998-12-22
CIMETIDINE — FDA application ANDA074972 — original approval 1998-06-19
MICONAZOLE NITRATE — FDA application ANDA074760 — original approval 1997-05-15
MICONAZOLE NITRATE — FDA application ANDA074395 — original approval 1997-03-20
NAPROXEN SODIUM — FDA application ANDA074661 — original approval 1997-01-13
CLINDETS — FDA application ANDA064136 — original approval 1996-09-30
DOXYLAMINE SUCCINATE — FDA application ANDA040167 — original approval 1996-09-18
LOPERAMIDE HYDROCHLORIDE — FDA application ANDA074194 — original approval 1992-10-30
LOPERAMIDE HYDROCHLORIDE — FDA application ANDA073243 — original approval 1992-01-21
IBUPROFEN — FDA application ANDA072098 — original approval 1987-12-08
CAP-PROFEN — FDA application ANDA072097 — original approval 1987-12-08
IBUPROFEN — FDA application ANDA072096 — original approval 1987-12-08
TAB-PROFEN — FDA application ANDA072095 — original approval 1987-12-08

REGN — REGENERON PHARMACEUTICALS, INC.

EYLEA HD — FDA application BLA761355 — original approval 2023-08-18
VEOPOZ — FDA application BLA761339 — original approval 2023-08-18
EVKEEZA — FDA application BLA761181 — original approval 2021-02-11
INMAZEB — FDA application BLA761169 — original approval 2020-10-14
LIBTAYO — FDA application BLA761097 — original approval 2018-09-28
DUPIXENT — FDA application BLA761055 — original approval 2017-03-28
PRALUENT — FDA application BLA125559 — original approval 2015-07-24
EYLEA — FDA application BLA125387 — original approval 2011-11-18

RIGL — RIGEL PHARMACEUTICALS INC

VEPPANU — FDA application NDA219835 — original approval 2026-05-01
REZLIDHIA — FDA application NDA215814 — original approval 2022-12-01
GAVRETO — FDA application NDA213721 — original approval 2020-09-04
TAVALISSE — FDA application NDA209299 — original approval 2018-04-17

SIGA — SIGA TECHNOLOGIES INC

TPOXX — FDA application NDA214518 — original approval 2022-05-18
TPOXX — FDA application NDA208627 — original approval 2018-07-13

SUPN — SUPERNUS PHARMACEUTICALS, INC.

QELBREE — FDA application NDA211964 — original approval 2021-04-02
OSMOLEX ER — FDA application NDA209410 — original approval 2018-02-16
GOCOVRI — FDA application NDA208944 — original approval 2017-08-24
TROKENDI XR — FDA application NDA201635 — original approval 2013-08-16
OXTELLAR XR — FDA application NDA202810 — original approval 2012-10-19

TGTX — TG THERAPEUTICS, INC.

BRIUMVI — FDA application BLA761238 — original approval 2022-12-28

URGN — UroGen Pharma Ltd.

ZUSDURI — FDA application NDA215793 — original approval 2025-06-12
JELMYTO — FDA application NDA211728 — original approval 2020-04-15

VERA — Vera Therapeutics, Inc.

TRUTAKNA — FDA application BLA761486 — original approval 2026-07-07

VNDA — Vanda Pharmaceuticals Inc.

BYSANTI — FDA application NDA220358 — original approval 2026-02-20
NEREUS — FDA application NDA220152 — original approval 2025-12-30
PONVORY — FDA application NDA213498 — original approval 2021-03-18
HETLIOZ LQ — FDA application NDA214517 — original approval 2020-12-01
HETLIOZ — FDA application NDA205677 — original approval 2014-01-31
FANAPT — FDA application NDA022192 — original approval 2009-05-06

VSTM — Verastem, Inc.

AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) — FDA application NDA219616 — original approval 2025-05-08

VTRS — Viatris Inc

TOBI PODHALER — FDA application NDA201688 — original approval 2013-03-22
REVATIO — FDA application NDA203109 — original approval 2012-08-30
REVATIO — FDA application NDA022473 — original approval 2009-11-18
EDLUAR — FDA application NDA021997 — original approval 2009-03-13
ASTEPRO — FDA application NDA022203 — original approval 2008-10-15
ELESTRIN — FDA application NDA021813 — original approval 2006-12-15
REVATIO — FDA application NDA021845 — original approval 2005-06-03
CARDURA XL — FDA application NDA021269 — original approval 2005-02-22
GEODON — FDA application NDA020919 — original approval 2002-06-21
GEODON — FDA application NDA020825 — original approval 2001-02-05
NITROSTAT — FDA application NDA021134 — original approval 2000-05-01
NEURONTIN — FDA application NDA021129 — original approval 2000-03-02
ZOLOFT — FDA application NDA020990 — original approval 1999-12-07
NEURONTIN — FDA application NDA020882 — original approval 1998-10-09
VIAGRA — FDA application NDA020895 — original approval 1998-03-27
TOBI — FDA application NDA050753 — original approval 1997-12-22
MUSE — FDA application NDA020700 — original approval 1996-11-19
NEURONTIN — FDA application NDA020235 — original approval 1993-12-30
NORVASC — FDA application NDA019787 — original approval 1992-07-31
ZOLOFT — FDA application NDA019839 — original approval 1991-12-30
CARDURA — FDA application NDA019668 — original approval 1990-11-02
EPI E Z PEN JR / EPIPEN / EPIPEN E Z PEN / EPIPEN JR. — FDA application NDA019430 — original approval 1987-12-22
CORTIFOAM — FDA application NDA017351 — original approval 1982-02-12
DILANTIN — FDA application ANDA084349 — original approval 1976-08-27
DILANTIN-125 / DILANTIN-30 — FDA application NDA008762 — original approval 1953-01-06