# FDA-approved drug applications

Informational only - not investment advice.

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](/drug/bla-761460/) — original approval 2026-05-27
- [EMRELIS — FDA application BLA761384](/drug/bla-761384/) — original approval 2025-05-14
- [EMBLAVEO — FDA application NDA217906](/drug/nda-217906/) — original approval 2025-02-07
- [VYALEV — FDA application NDA216962](/drug/nda-216962/) — original approval 2024-10-16
- [RINVOQ LQ — FDA application NDA218347](/drug/nda-218347/) — original approval 2024-04-26
- [SKYRIZI — FDA application BLA761262](/drug/bla-761262/) — original approval 2022-06-16
- [VUITY — FDA application NDA214028](/drug/nda-214028/) — original approval 2021-10-28
- [QULIPTA — FDA application NDA215206](/drug/nda-215206/) — original approval 2021-09-28
- [MAVYRET — FDA application NDA215110](/drug/nda-215110/) — original approval 2021-06-10
- [ORIAHNN (COPACKAGED) — FDA application NDA213388](/drug/nda-213388/) — original approval 2020-05-29
- [DURYSTA — FDA application NDA211911](/drug/nda-211911/) — original approval 2020-03-04
- [UBRELVY — FDA application NDA211765](/drug/nda-211765/) — original approval 2019-12-23
- [RINVOQ — FDA application NDA211675](/drug/nda-211675/) — original approval 2019-08-16
- [SKYRIZI — FDA application BLA761105](/drug/bla-761105/) — original approval 2019-04-23
- [ORILISSA — FDA application NDA210450](/drug/nda-210450/) — original approval 2018-07-23
- [MAVYRET — FDA application NDA209394](/drug/nda-209394/) — original approval 2017-08-03
- [NORVIR — FDA application NDA209512](/drug/nda-209512/) — original approval 2017-06-07
- [VIEKIRA XR — FDA application NDA208624](/drug/nda-208624/) — original approval 2016-07-22
- [BYVALSON — FDA application NDA206302](/drug/nda-206302/) — original approval 2016-06-03
- [VENCLEXTA — FDA application NDA208573](/drug/nda-208573/) — original approval 2016-04-11
- [VRAYLAR — FDA application NDA204370](/drug/nda-204370/) — original approval 2015-09-17
- [TECHNIVIE — FDA application NDA207931](/drug/nda-207931/) — original approval 2015-07-24
- [VIBERZI — FDA application NDA206940](/drug/nda-206940/) — original approval 2015-05-27
- [KYBELLA — FDA application NDA206333](/drug/nda-206333/) — original approval 2015-04-29
- [AVYCAZ — FDA application NDA206494](/drug/nda-206494/) — original approval 2015-02-25
- [DUOPA — FDA application NDA203952](/drug/nda-203952/) — original approval 2015-01-09
- [NAMZARIC — FDA application NDA206439](/drug/nda-206439/) — original approval 2014-12-23
- [VIEKIRA PAK (COPACKAGED) — FDA application NDA206619](/drug/nda-206619/) — original approval 2014-12-19
- [DALVANCE — FDA application NDA021883](/drug/nda-021883/) — original approval 2014-05-23
- [FETZIMA — FDA application NDA204168](/drug/nda-204168/) — original approval 2013-07-25
- [DELZICOL — FDA application NDA204412](/drug/nda-204412/) — original approval 2013-02-01
- [OXYTROL FOR WOMEN — FDA application NDA202211](/drug/nda-202211/) — original approval 2013-01-25
- [LINZESS — FDA application NDA202811](/drug/nda-202811/) — original approval 2012-08-30
- [RECTIV — FDA application NDA021359](/drug/nda-021359/) — original approval 2011-06-21
- [VIIBRYD — FDA application NDA022567](/drug/nda-022567/) — original approval 2011-01-21
- [TEFLARO — FDA application NDA200327](/drug/nda-200327/) — original approval 2010-10-29
- [LUMIGAN — FDA application NDA022184](/drug/nda-022184/) — original approval 2010-08-31
- [LASTACAFT — FDA application NDA022134](/drug/nda-022134/) — original approval 2010-07-28
- [NAMENDA XR — FDA application NDA022525](/drug/nda-022525/) — original approval 2010-06-21
- [ZYMAXID — FDA application NDA022548](/drug/nda-022548/) — original approval 2010-05-18
- [NORVIR — FDA application NDA022417](/drug/nda-022417/) — original approval 2010-02-10
- [SAPHRIS — FDA application NDA022117](/drug/nda-022117/) — original approval 2009-08-13
- [ACUVAIL — FDA application NDA022427](/drug/nda-022427/) — original approval 2009-07-22
- [OZURDEX — FDA application NDA022315](/drug/nda-022315/) — original approval 2009-06-17
- [CREON — FDA application BLA020725](/drug/bla-020725/) — original approval 2009-04-30
- [GELNIQUE — FDA application NDA022204](/drug/nda-022204/) — original approval 2009-01-27
- [SAVELLA — FDA application NDA022256](/drug/nda-022256/) — original approval 2009-01-14
- [LATISSE — FDA application NDA022369](/drug/nda-022369/) — original approval 2008-12-24
- [TRILIPIX — FDA application NDA022224](/drug/nda-022224/) — original approval 2008-12-15
- [RAPAFLO — FDA application NDA022206](/drug/nda-022206/) — original approval 2008-10-08
- [ASACOL HD — FDA application NDA021830](/drug/nda-021830/) — original approval 2008-05-29
- [DEPAKOTE ER — FDA application NDA022267](/drug/nda-022267/) — original approval 2008-03-24
- [COMBIGAN — FDA application NDA021398](/drug/nda-021398/) — original approval 2007-10-30
- [KALETRA — FDA application NDA021906](/drug/nda-021906/) — original approval 2005-10-28
- [ALPHAGAN P — FDA application NDA021770](/drug/nda-021770/) — original approval 2005-08-19
- [ZEMPLAR — FDA application NDA021606](/drug/nda-021606/) — original approval 2005-05-26
- [ENABLEX — FDA application NDA021513](/drug/nda-021513/) — original approval 2004-12-22
- [TRICOR — FDA application NDA021656](/drug/nda-021656/) — original approval 2004-11-05
- [NAMENDA — FDA application NDA021487](/drug/nda-021487/) — original approval 2003-10-16
- [ACULAR LS — FDA application NDA021528](/drug/nda-021528/) — original approval 2003-05-30
- [HUMIRA — FDA application BLA125057](/drug/bla-125057/) — original approval 2002-12-31
- [RESTASIS / RESTASIS MULTIDOSE — FDA application NDA050790](/drug/nda-050790/) — original approval 2002-12-23
- [LEXAPRO — FDA application NDA021365](/drug/nda-021365/) — original approval 2002-11-27
- [LEXAPRO — FDA application NDA021323](/drug/nda-021323/) — original approval 2002-08-14
- [SYNTHROID — FDA application NDA021402](/drug/nda-021402/) — original approval 2002-07-24
- [FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER — FDA application ANDA075729](/drug/anda-075729/) — original approval 2001-12-17
- [TEVETEN HCT — FDA application NDA021268](/drug/nda-021268/) — original approval 2001-11-01
- [TRICOR — FDA application NDA021203](/drug/nda-021203/) — original approval 2001-09-04
- [LUMIGAN — FDA application NDA021275](/drug/nda-021275/) — original approval 2001-03-16
- [ALPHAGAN P — FDA application NDA021262](/drug/nda-021262/) — original approval 2001-03-16
- [CANASA — FDA application NDA021252](/drug/nda-021252/) — original approval 2001-01-05
- [KALETRA — FDA application NDA021251](/drug/nda-021251/) — original approval 2000-09-15
- [KALETRA — FDA application NDA021226](/drug/nda-021226/) — original approval 2000-09-15
- [DEPAKOTE ER — FDA application NDA021168](/drug/nda-021168/) — original approval 2000-08-04
- [VANIQA — FDA application NDA021145](/drug/nda-021145/) — original approval 2000-07-27
- [GENGRAF — FDA application ANDA065003](/drug/anda-065003/) — original approval 2000-05-12
- [BIAXIN XL — FDA application NDA050775](/drug/nda-050775/) — original approval 2000-03-03
- [CYCLOSPORINE — FDA application ANDA065025](/drug/anda-065025/) — original approval 2000-03-03
- [ACYCLOVIR — FDA application ANDA075114](/drug/anda-075114/) — original approval 1999-07-26
- [NORVIR — FDA application NDA020945](/drug/nda-020945/) — original approval 1999-06-29
- [CELEXA — FDA application NDA020822](/drug/nda-020822/) — original approval 1998-07-17
- [ZEMPLAR — FDA application NDA020819](/drug/nda-020819/) — original approval 1998-04-17
- [TEVETEN — FDA application NDA020738](/drug/nda-020738/) — original approval 1997-12-22
- [URSO 250 / URSO FORTE — FDA application NDA020675](/drug/nda-020675/) — original approval 1997-12-10
- [OMNICEF — FDA application NDA050749](/drug/nda-050749/) — original approval 1997-12-04
- [OMNICEF — FDA application NDA050739](/drug/nda-050739/) — original approval 1997-12-04
- [VICOPROFEN — FDA application NDA020716](/drug/nda-020716/) — original approval 1997-09-23
- [CRINONE — FDA application NDA020701](/drug/nda-020701/) — original approval 1997-07-31
- [NIASPAN / NIASPAN TITRATION STARTER PACK — FDA application NDA020381](/drug/nda-020381/) — original approval 1997-07-28
- [IOPAMIDOL-300 — FDA application ANDA074638](/drug/anda-074638/) — original approval 1997-04-30
- [DEPACON — FDA application NDA020593](/drug/nda-020593/) — original approval 1996-12-30
- [ALORA — FDA application NDA020655](/drug/nda-020655/) — original approval 1996-12-20
- [TARKA — FDA application NDA020591](/drug/nda-020591/) — original approval 1996-10-22
- [VICODIN HP — FDA application ANDA040117](/drug/anda-040117/) — original approval 1996-09-23
- [MAVIK — FDA application NDA020528](/drug/nda-020528/) — original approval 1996-04-26
- [NORVIR — FDA application NDA020659](/drug/nda-020659/) — original approval 1996-03-01
- [NIMBEX / NIMBEX PRESERVATIVE FREE — FDA application NDA020551](/drug/nda-020551/) — original approval 1995-12-15
- [ANDRODERM — FDA application NDA020489](/drug/nda-020489/) — original approval 1995-09-29
- [ULTANE — FDA application NDA020478](/drug/nda-020478/) — original approval 1995-06-07
- [LIPIDIL / TRICOR (MICRONIZED) — FDA application NDA019304](/drug/nda-019304/) — original approval 1993-12-31
- [BIAXIN — FDA application NDA050698](/drug/nda-050698/) — original approval 1993-12-23
- [BIAXIN XL — FDA application NDA050697](/drug/nda-050697/) — original approval 1993-12-23
- [CARAFATE — FDA application NDA019183](/drug/nda-019183/) — original approval 1993-12-16
- [NALBUPHINE HYDROCHLORIDE — FDA application NDA020200](/drug/nda-020200/) — original approval 1993-03-12
- [ACULAR — FDA application NDA019700](/drug/nda-019700/) — original approval 1992-11-09
- [MIVACRON / MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER — FDA application NDA020098](/drug/nda-020098/) — original approval 1992-01-22
- [BIAXIN — FDA application NDA050662](/drug/nda-050662/) — original approval 1991-10-31
- [SURVANTA — FDA application BLA020032](/drug/bla-020032/) — original approval 1991-07-01
- [NUROMAX — FDA application NDA019946](/drug/nda-019946/) — original approval 1991-03-07
- [DEPAKOTE — FDA application NDA019680](/drug/nda-019680/) — original approval 1989-09-12
- [CARTROL — FDA application NDA019204](/drug/nda-019204/) — original approval 1988-12-28
- [VICODIN ES — FDA application ANDA089736](/drug/anda-089736/) — original approval 1988-12-09
- [ATROPINE — FDA application ANDA071295](/drug/anda-071295/) — original approval 1987-01-30
- [CALCIJEX — FDA application NDA018874](/drug/nda-018874/) — original approval 1986-09-25
- [FML FORTE — FDA application NDA019216](/drug/nda-019216/) — original approval 1986-04-23
- [ESTRACE — FDA application ANDA086069](/drug/anda-086069/) — original approval 1984-01-31
- [DEPAKOTE — FDA application NDA018723](/drug/nda-018723/) — original approval 1983-03-10
- [VICODIN — FDA application ANDA088058](/drug/anda-088058/) — original approval 1983-01-07
- [AZMACORT — FDA application NDA018117](/drug/nda-018117/) — original approval 1982-04-23
- [CARAFATE — FDA application NDA018333](/drug/nda-018333/) — original approval 1981-10-30
- [NITROPRESS — FDA application NDA018450](/drug/nda-018450/) — original approval 1981-09-08
- [K-TAB — FDA application NDA018279](/drug/nda-018279/) — original approval 1980-06-09
- [DEPAKENE — FDA application NDA018082](/drug/nda-018082/) — original approval 1978-02-28
- [DEPAKENE — FDA application NDA018081](/drug/nda-018081/) — original approval 1978-02-28
- [PRED FORTE — FDA application NDA017011](/drug/nda-017011/) — original approval 1973-05-30
- [PRED MILD — FDA application NDA017100](/drug/nda-017100/) — original approval 1972-11-10
- [FML — FDA application NDA016851](/drug/nda-016851/) — original approval 1972-01-12
- [CHOLOXIN — FDA application NDA012302](/drug/nda-012302/) — original approval 1967-04-14
- [PLACIDYL — FDA application NDA010021](/drug/nda-010021/) — original approval 1961-05-10
- [AKINETON — FDA application NDA012418](/drug/nda-012418/) — original approval 1961-04-20
- [ENDURON — FDA application NDA012524](/drug/nda-012524/) — original approval 1960-10-21
- [ORETICYL 25 / ORETICYL 50 / ORETICYL FORTE — FDA application NDA012148](/drug/nda-012148/) — original approval 1959-12-14
- [AKINETON — FDA application NDA012003](/drug/nda-012003/) — original approval 1959-09-08
- [ORETIC — FDA application NDA011971](/drug/nda-011971/) — original approval 1959-07-06
- [HARMONYL — FDA application NDA010796](/drug/nda-010796/) — original approval 1957-04-19
- [TRAL — FDA application NDA010599](/drug/nda-010599/) — original approval 1957-02-13
- [BENTYL / BENTYL PRESERVATIVE FREE — FDA application NDA008370](/drug/nda-008370/) — original approval 1952-08-13
- [PHENURONE — FDA application NDA007707](/drug/nda-007707/) — original approval 1951-06-28
- [PARADIONE — FDA application NDA006800](/drug/nda-006800/) — original approval 1949-06-15
- [TRIDIONE — FDA application NDA005856](/drug/nda-005856/) — original approval 1946-01-25
- [DICUMAROL — FDA application NDA005545](/drug/nda-005545/) — original approval 1944-07-31

## ABT — ABBOTT LABORATORIES

- [CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER — FDA application ANDA065027](/drug/anda-065027/) — original approval 2001-06-29

## ACAD — ACADIA PHARMACEUTICALS INC

- [DAYBUE STIX — FDA application NDA219884](/drug/nda-219884/) — original approval 2025-12-11
- [DAYBUE — FDA application NDA217026](/drug/nda-217026/) — original approval 2023-03-10
- [NUPLAZID — FDA application NDA210793](/drug/nda-210793/) — original approval 2018-06-28
- [NUPLAZID — FDA application NDA207318](/drug/nda-207318/) — original approval 2016-04-29

## ADCT — ADC Therapeutics SA

- [ZYNLONTA — FDA application BLA761196](/drug/bla-761196/) — original approval 2021-04-23

## AGIO — AGIOS PHARMACEUTICALS, INC.

- [AQVESME / PYRUKYND — FDA application NDA216196](/drug/nda-216196/) — original approval 2022-02-17

## ALKS — Alkermes plc.

- [LYBALVI — FDA application NDA213378](/drug/nda-213378/) — original approval 2021-05-28
- [ARISTADA INITIO KIT — FDA application NDA209830](/drug/nda-209830/) — original approval 2018-06-29
- [ARISTADA — FDA application NDA207533](/drug/nda-207533/) — original approval 2015-10-05
- [VIVITROL — FDA application NDA021897](/drug/nda-021897/) — original approval 2006-04-13

## ALNY — ALNYLAM PHARMACEUTICALS, INC.

- [AMVUTTRA — FDA application NDA215515](/drug/nda-215515/) — original approval 2022-06-13
- [OXLUMO — FDA application NDA214103](/drug/nda-214103/) — original approval 2020-11-23
- [GIVLAARI — FDA application NDA212194](/drug/nda-212194/) — original approval 2019-11-20
- [ONPATTRO — FDA application NDA210922](/drug/nda-210922/) — original approval 2018-08-10

## AMGN — AMGEN INC

- [OTEZLA / OTEZLA XR — FDA application NDA210745](/drug/nda-210745/) — original approval 2025-08-29
- [PAVBLU — FDA application BLA761298](/drug/bla-761298/) — original approval 2024-08-23
- [BKEMV — FDA application BLA761333](/drug/bla-761333/) — original approval 2024-05-28
- [IMDELLTRA — FDA application BLA761344](/drug/bla-761344/) — original approval 2024-05-16
- [WEZLANA — FDA application BLA761331](/drug/bla-761331/) — original approval 2023-10-31
- [WEZLANA — FDA application BLA761285](/drug/bla-761285/) — original approval 2023-10-31
- [LUMAKRAS — FDA application NDA214665](/drug/nda-214665/) — original approval 2021-05-28
- [RIABNI — FDA application BLA761140](/drug/bla-761140/) — original approval 2020-12-17
- [AVSOLA — FDA application BLA761086](/drug/bla-761086/) — original approval 2019-12-06
- [KANJINTI — FDA application BLA761073](/drug/bla-761073/) — original approval 2019-06-13
- [CORLANOR — FDA application NDA209964](/drug/nda-209964/) — original approval 2019-04-22
- [EVENITY — FDA application BLA761062](/drug/bla-761062/) — original approval 2019-04-09
- [AIMOVIG — FDA application BLA761077](/drug/bla-761077/) — original approval 2018-05-17
- [MVASI — FDA application BLA761028](/drug/bla-761028/) — original approval 2017-09-14
- [AMJEVITA — FDA application BLA761024](/drug/bla-761024/) — original approval 2016-09-23
- [CORLANOR — FDA application NDA206143](/drug/nda-206143/) — original approval 2015-04-15
- [BLINCYTO — FDA application BLA125557](/drug/bla-125557/) — original approval 2014-12-03
- [OTEZLA — FDA application NDA205437](/drug/nda-205437/) — original approval 2014-03-21
- [PROLIA / XGEVA — FDA application BLA125320](/drug/bla-125320/) — original approval 2010-06-01
- [NPLATE — FDA application BLA125268](/drug/bla-125268/) — original approval 2008-08-22
- [VECTIBIX — FDA application BLA125147](/drug/bla-125147/) — original approval 2006-09-27
- [SENSIPAR — FDA application NDA021688](/drug/nda-021688/) — original approval 2004-03-08
- [NEULASTA — FDA application BLA125031](/drug/bla-125031/) — original approval 2002-01-31
- [ARANESP — FDA application BLA103951](/drug/bla-103951/) — original approval 2001-09-17
- [NEUPOGEN — FDA application BLA103353](/drug/bla-103353/) — original approval 1991-02-20
- [EPOGEN/PROCRIT — FDA application BLA103234](/drug/bla-103234/) — original approval 1989-06-01

## AMPH — Amphastar Pharmaceuticals, Inc.

- [TERIPARATIDE — FDA application ANDA213641](/drug/anda-213641/) — original approval 2025-12-12
- [REXTOVY — FDA application NDA208969](/drug/nda-208969/) — original approval 2023-03-07
- [VASOPRESSIN — FDA application ANDA211857](/drug/anda-211857/) — original approval 2022-07-18
- [GANIRELIX ACETATE — FDA application ANDA212613](/drug/anda-212613/) — original approval 2022-04-07
- [GLUCAGON — FDA application ANDA208086](/drug/anda-208086/) — original approval 2020-12-28
- [SUCCINYLCHOLINE CHLORIDE — FDA application ANDA213432](/drug/anda-213432/) — original approval 2020-06-08
- [BAQSIMI — FDA application NDA210134](/drug/nda-210134/) — original approval 2019-07-24
- [ENOXAPARIN SODIUM — FDA application ANDA208600](/drug/anda-208600/) — original approval 2019-03-14
- [ISOPROTERENOL HYDROCHLORIDE — FDA application ANDA210106](/drug/anda-210106/) — original approval 2018-06-18
- [SODIUM NITROPRUSSIDE — FDA application ANDA209832](/drug/anda-209832/) — original approval 2017-12-18
- [MEDROXYPROGESTERONE ACETATE — FDA application ANDA077334](/drug/anda-077334/) — original approval 2017-11-28
- [MEDROXYPROGESTERONE ACETATE — FDA application ANDA077235](/drug/anda-077235/) — original approval 2017-11-28
- [NEOSTIGMINE METHYLSULFATE — FDA application ANDA209933](/drug/anda-209933/) — original approval 2017-09-25
- [DUOCAINE — FDA application NDA021496](/drug/nda-021496/) — original approval 2003-05-23
- [CORTROSYN — FDA application NDA016750](/drug/nda-016750/) — original approval 1970-04-22

## AMRX — Amneal Pharmaceuticals, Inc.

- [OZILTUS — FDA application BLA761457](/drug/bla-761457/) — original approval 2025-12-19
- [BONCRESA — FDA application BLA761456](/drug/bla-761456/) — original approval 2025-12-19
- [LACOSAMIDE — FDA application ANDA204839](/drug/anda-204839/) — original approval 2024-03-27
- [CARBAMAZEPINE — FDA application ANDA212704](/drug/anda-212704/) — original approval 2023-09-22
- [VALSARTAN AND HYDROCHLOROTHIAZIDE — FDA application ANDA204382](/drug/anda-204382/) — original approval 2023-08-11
- [VIGABATRIN — FDA application ANDA210042](/drug/anda-210042/) — original approval 2022-06-22
- [ESTRADIOL AND PROGESTERONE — FDA application ANDA214293](/drug/anda-214293/) — original approval 2022-05-16
- [SUCRALFATE — FDA application ANDA215576](/drug/anda-215576/) — original approval 2022-04-15
- [ALYMSYS — FDA application BLA761231](/drug/bla-761231/) — original approval 2022-04-13
- [LACOSAMIDE — FDA application ANDA204857](/drug/anda-204857/) — original approval 2022-03-17
- [NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE — FDA application ANDA214292](/drug/anda-214292/) — original approval 2021-07-20
- [MONTELUKAST SODIUM — FDA application ANDA205107](/drug/anda-205107/) — original approval 2020-09-04
- [DEXMEDETOMIDINE HYDROCHLORIDE — FDA application ANDA207551](/drug/anda-207551/) — original approval 2020-05-20
- [SILDENAFIL CITRATE — FDA application ANDA211092](/drug/anda-211092/) — original approval 2019-11-27
- [ERYTHROMYCIN ETHYLSUCCINATE — FDA application ANDA211204](/drug/anda-211204/) — original approval 2019-11-01
- [PALIPERIDONE — FDA application ANDA204707](/drug/anda-204707/) — original approval 2019-09-23
- [PREGABALIN — FDA application ANDA209743](/drug/anda-209743/) — original approval 2019-07-19
- [ERYTHROMYCIN — FDA application ANDA210954](/drug/anda-210954/) — original approval 2019-07-02
- [CHLORTHALIDONE — FDA application ANDA207204](/drug/anda-207204/) — original approval 2019-07-01
- [SOLIFENACIN SUCCINATE — FDA application ANDA209719](/drug/anda-209719/) — original approval 2019-05-20
- [BOSENTAN — FDA application ANDA209742](/drug/anda-209742/) — original approval 2019-04-26
- [TADALAFIL — FDA application ANDA209744](/drug/anda-209744/) — original approval 2019-03-26
- [IMATINIB MESYLATE — FDA application ANDA207495](/drug/anda-207495/) — original approval 2019-02-08
- [LEVOMILNACIPRAN HYDROCHLORIDE — FDA application ANDA210790](/drug/anda-210790/) — original approval 2019-02-04
- [RIVASTIGMINE — FDA application ANDA207308](/drug/anda-207308/) — original approval 2019-01-08
- [ABIRATERONE ACETATE — FDA application ANDA208327](/drug/anda-208327/) — original approval 2019-01-07
- [LURASIDONE HYDROCHLORIDE — FDA application ANDA208002](/drug/anda-208002/) — original approval 2019-01-03
- [EXEMESTANE — FDA application ANDA206421](/drug/anda-206421/) — original approval 2018-12-28
- [SILODOSIN — FDA application ANDA209745](/drug/anda-209745/) — original approval 2018-12-03
- [LAMOTRIGINE — FDA application ANDA207497](/drug/anda-207497/) — original approval 2018-11-30
- [FROVATRIPTAN SUCCINATE — FDA application ANDA211292](/drug/anda-211292/) — original approval 2018-11-06
- [GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE — FDA application ANDA209692](/drug/anda-209692/) — original approval 2018-11-01
- [CLOMIPRAMINE HYDROCHLORIDE — FDA application ANDA208632](/drug/anda-208632/) — original approval 2018-10-31
- [QUETIAPINE FUMARATE — FDA application ANDA211405](/drug/anda-211405/) — original approval 2018-10-26
- [NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE — FDA application ANDA209726](/drug/anda-209726/) — original approval 2018-10-23
- [CLOBAZAM — FDA application ANDA209718](/drug/anda-209718/) — original approval 2018-10-22
- [URSODIOL — FDA application ANDA211301](/drug/anda-211301/) — original approval 2018-10-16
- [ROSUVASTATIN CALCIUM — FDA application ANDA208850](/drug/anda-208850/) — original approval 2018-10-16
- [TERIFLUNOMIDE — FDA application ANDA209613](/drug/anda-209613/) — original approval 2018-09-28
- [AMPHETAMINE SULFATE — FDA application ANDA211139](/drug/anda-211139/) — original approval 2018-09-26
- [METHYLERGONOVINE MALEATE — FDA application ANDA211483](/drug/anda-211483/) — original approval 2018-09-10
- [CHLORPROMAZINE HYDROCHLORIDE — FDA application ANDA209755](/drug/anda-209755/) — original approval 2018-09-10
- [EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — FDA application ANDA209721](/drug/anda-209721/) — original approval 2018-08-22
- [GUAIFENESIN — FDA application ANDA207342](/drug/anda-207342/) — original approval 2018-07-11
- [PRASUGREL — FDA application ANDA205913](/drug/anda-205913/) — original approval 2018-06-19
- [ETODOLAC — FDA application ANDA208834](/drug/anda-208834/) — original approval 2018-06-07
- [CELECOXIB — FDA application ANDA208833](/drug/anda-208833/) — original approval 2018-05-31
- [ALBUTEROL SULFATE — FDA application ANDA208804](/drug/anda-208804/) — original approval 2018-05-21
- [HYDROXYCHLOROQUINE SULFATE — FDA application ANDA210577](/drug/anda-210577/) — original approval 2018-05-15
- [PHYTONADIONE — FDA application ANDA209373](/drug/anda-209373/) — original approval 2018-05-11
- [ETHACRYNIC ACID — FDA application ANDA208805](/drug/anda-208805/) — original approval 2018-05-08
- [IRBESARTAN — FDA application ANDA204740](/drug/anda-204740/) — original approval 2018-04-17
- [VIGABATRIN — FDA application ANDA210155](/drug/anda-210155/) — original approval 2018-03-13
- [ERYTHROMYCIN — FDA application ANDA209720](/drug/anda-209720/) — original approval 2018-03-09
- [METHYLPHENIDATE HYDROCHLORIDE — FDA application ANDA207515](/drug/anda-207515/) — original approval 2018-02-01
- [ARGATROBAN — FDA application ANDA206698](/drug/anda-206698/) — original approval 2018-01-26
- [METHOTREXATE SODIUM — FDA application ANDA210040](/drug/anda-210040/) — original approval 2017-12-22
- [TIAGABINE HYDROCHLORIDE — FDA application ANDA208181](/drug/anda-208181/) — original approval 2017-12-08
- [SEVELAMER CARBONATE — FDA application ANDA207288](/drug/anda-207288/) — original approval 2017-11-28
- [EZETIMIBE AND SIMVASTATIN — FDA application ANDA208831](/drug/anda-208831/) — original approval 2017-11-21
- [BUMETANIDE — FDA application ANDA209724](/drug/anda-209724/) — original approval 2017-10-18
- [DOXYCYCLINE HYCLATE — FDA application ANDA209372](/drug/anda-209372/) — original approval 2017-10-06
- [NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE — FDA application ANDA207514](/drug/anda-207514/) — original approval 2017-09-11
- [BUDESONIDE — FDA application ANDA206200](/drug/anda-206200/) — original approval 2017-07-31
- [DOXEPIN HYDROCHLORIDE — FDA application ANDA207482](/drug/anda-207482/) — original approval 2017-06-28
- [CALCITRIOL — FDA application ANDA203289](/drug/anda-203289/) — original approval 2017-06-14
- [EZETIMIBE — FDA application ANDA208803](/drug/anda-208803/) — original approval 2017-06-12
- [NADOLOL — FDA application ANDA208832](/drug/anda-208832/) — original approval 2017-06-02
- [BUSPIRONE HYDROCHLORIDE — FDA application ANDA208829](/drug/anda-208829/) — original approval 2017-05-24
- [OSELTAMIVIR PHOSPHATE — FDA application ANDA209093](/drug/anda-209093/) — original approval 2017-05-17
- [ESCITALOPRAM OXALATE — FDA application ANDA205619](/drug/anda-205619/) — original approval 2017-05-17
- [NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) — FDA application ANDA207372](/drug/anda-207372/) — original approval 2017-05-15
- [OXAPROZIN — FDA application ANDA208633](/drug/anda-208633/) — original approval 2017-05-04
- [MOMETASONE FUROATE — FDA application ANDA207989](/drug/anda-207989/) — original approval 2017-04-03
- [PARICALCITOL — FDA application ANDA206699](/drug/anda-206699/) — original approval 2017-03-09
- [TRANEXAMIC ACID — FDA application ANDA208840](/drug/anda-208840/) — original approval 2017-02-28
- [CAPECITABINE — FDA application ANDA204741](/drug/anda-204741/) — original approval 2017-02-28
- [ALOSETRON HYDROCHLORIDE — FDA application ANDA206647](/drug/anda-206647/) — original approval 2016-12-22
- [HYDROCODONE BITARTRATE AND ACETAMINOPHEN — FDA application ANDA207137](/drug/anda-207137/) — original approval 2016-11-29
- [DICLOFENAC SODIUM AND MISOPROSTOL — FDA application ANDA203995](/drug/anda-203995/) — original approval 2016-11-25
- [MEMANTINE HYDROCHLORIDE — FDA application ANDA205825](/drug/anda-205825/) — original approval 2016-10-12
- [COLCHICINE — FDA application ANDA204711](/drug/anda-204711/) — original approval 2016-09-28
- [ITRACONAZOLE — FDA application ANDA205080](/drug/anda-205080/) — original approval 2016-09-26
- [DICLOFENAC SODIUM — FDA application ANDA206116](/drug/anda-206116/) — original approval 2016-09-02
- [FUROSEMIDE — FDA application ANDA207552](/drug/anda-207552/) — original approval 2016-07-20
- [DOXYCYCLINE HYCLATE — FDA application ANDA207289](/drug/anda-207289/) — original approval 2016-06-27
- [ARIPIPRAZOLE — FDA application ANDA204838](/drug/anda-204838/) — original approval 2016-06-17
- [TEMAZEPAM — FDA application ANDA203482](/drug/anda-203482/) — original approval 2016-05-23
- [MILNACIPRAN HYDROCHLORIDE — FDA application ANDA205081](/drug/anda-205081/) — original approval 2016-04-22
- [VORICONAZOLE — FDA application ANDA205034](/drug/anda-205034/) — original approval 2016-04-13
- [MEROPENEM — FDA application ANDA205883](/drug/anda-205883/) — original approval 2016-04-12
- [RALOXIFENE HYDROCHLORIDE — FDA application ANDA208206](/drug/anda-208206/) — original approval 2016-04-08
- [DICLOFENAC SODIUM — FDA application ANDA208077](/drug/anda-208077/) — original approval 2016-03-18
- [DESIPRAMINE HYDROCHLORIDE — FDA application ANDA208105](/drug/anda-208105/) — original approval 2016-03-17
- [ASPIRIN AND DIPYRIDAMOLE — FDA application ANDA206392](/drug/anda-206392/) — original approval 2016-03-08
- [PANTOPRAZOLE SODIUM — FDA application ANDA205119](/drug/anda-205119/) — original approval 2016-01-26
- [PARICALCITOL — FDA application ANDA204327](/drug/anda-204327/) — original approval 2016-01-13
- [VALSARTAN — FDA application ANDA204011](/drug/anda-204011/) — original approval 2016-01-11
- [LINEZOLID — FDA application ANDA204536](/drug/anda-204536/) — original approval 2015-12-21
- [NIACIN — FDA application ANDA204178](/drug/anda-204178/) — original approval 2015-12-11
- [OMEGA-3-ACID ETHYL ESTERS — FDA application ANDA204940](/drug/anda-204940/) — original approval 2015-11-27
- [OXYBUTYNIN CHLORIDE — FDA application ANDA204010](/drug/anda-204010/) — original approval 2015-11-23
- [DUTASTERIDE — FDA application ANDA203118](/drug/anda-203118/) — original approval 2015-11-20
- [ENTECAVIR — FDA application ANDA206652](/drug/anda-206652/) — original approval 2015-11-12
- [ITRACONAZOLE — FDA application ANDA205573](/drug/anda-205573/) — original approval 2015-10-30
- [TELMISARTAN — FDA application ANDA204415](/drug/anda-204415/) — original approval 2015-09-08
- [MONTELUKAST SODIUM — FDA application ANDA204604](/drug/anda-204604/) — original approval 2015-09-04
- [PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE — FDA application ANDA200963](/drug/anda-200963/) — original approval 2015-08-26
- [ARIPIPRAZOLE — FDA application ANDA203906](/drug/anda-203906/) — original approval 2015-08-14
- [LIDOCAINE — FDA application ANDA206297](/drug/anda-206297/) — original approval 2015-08-07
- [RABEPRAZOLE SODIUM — FDA application ANDA204179](/drug/anda-204179/) — original approval 2015-07-31
- [NIACIN — FDA application ANDA203578](/drug/anda-203578/) — original approval 2015-07-24
- [QUININE SULFATE — FDA application ANDA203729](/drug/anda-203729/) — original approval 2015-07-15
- [TOBRAMYCIN — FDA application ANDA205501](/drug/anda-205501/) — original approval 2015-07-13
- [ESTRADIOL — FDA application ANDA205256](/drug/anda-205256/) — original approval 2015-05-29
- [DIVALPROEX SODIUM — FDA application ANDA203730](/drug/anda-203730/) — original approval 2015-05-29
- [TEMOZOLOMIDE — FDA application ANDA203691](/drug/anda-203691/) — original approval 2015-05-08
- [MEMANTINE HYDROCHLORIDE — FDA application ANDA090041](/drug/anda-090041/) — original approval 2015-04-10
- [LEVONORGESTREL AND ETHINYL ESTRADIOL — FDA application ANDA201095](/drug/anda-201095/) — original approval 2014-12-08
- [CALCIUM ACETATE — FDA application ANDA201658](/drug/anda-201658/) — original approval 2014-10-06
- [ACYCLOVIR — FDA application ANDA204605](/drug/anda-204605/) — original approval 2014-06-18
- [OXYCODONE HYDROCHLORIDE — FDA application ANDA203638](/drug/anda-203638/) — original approval 2014-06-03
- [CLOPIDOGREL BISULFATE — FDA application ANDA203751](/drug/anda-203751/) — original approval 2014-04-11
- [ATOVAQUONE — FDA application ANDA202960](/drug/anda-202960/) — original approval 2014-03-18
- [IBUPROFEN — FDA application ANDA079233](/drug/anda-079233/) — original approval 2014-03-18
- [CLINDAMYCIN PALMITATE HYDROCHLORIDE — FDA application ANDA203513](/drug/anda-203513/) — original approval 2014-03-13
- [LEVONORGESTREL AND ETHINYL ESTRADIOL — FDA application ANDA201108](/drug/anda-201108/) — original approval 2014-02-05
- [NORETHINDRONE — FDA application ANDA202260](/drug/anda-202260/) — original approval 2013-08-01
- [METAXALONE — FDA application ANDA203399](/drug/anda-203399/) — original approval 2013-06-21
- [PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE — FDA application ANDA200894](/drug/anda-200894/) — original approval 2013-04-24
- [WARFARIN SODIUM — FDA application ANDA202202](/drug/anda-202202/) — original approval 2013-03-04
- [SILDENAFIL CITRATE — FDA application ANDA202025](/drug/anda-202025/) — original approval 2013-02-28
- [BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE — FDA application ANDA203136](/drug/anda-203136/) — original approval 2013-02-22
- [POTASSIUM CHLORIDE — FDA application ANDA202128](/drug/anda-202128/) — original approval 2013-02-22
- [OXCARBAZEPINE — FDA application ANDA202961](/drug/anda-202961/) — original approval 2012-09-17
- [NORETHINDRONE ACETATE — FDA application ANDA200275](/drug/anda-200275/) — original approval 2012-07-30
- [GABAPENTIN — FDA application ANDA202024](/drug/anda-202024/) — original approval 2012-03-23
- [ESCITALOPRAM OXALATE — FDA application ANDA202227](/drug/anda-202227/) — original approval 2012-03-14
- [IBUPROFEN — FDA application ANDA202300](/drug/anda-202300/) — original approval 2011-12-23
- [FELBAMATE — FDA application ANDA202385](/drug/anda-202385/) — original approval 2011-12-16
- [NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE — FDA application ANDA078892](/drug/anda-078892/) — original approval 2011-09-26
- [FELBAMATE — FDA application ANDA201680](/drug/anda-201680/) — original approval 2011-09-13
- [RISPERIDONE — FDA application ANDA091384](/drug/anda-091384/) — original approval 2011-05-25
- [NITROFURANTOIN — FDA application ANDA201679](/drug/anda-201679/) — original approval 2011-05-11
- [MECLIZINE HYDROCHLORIDE — FDA application ANDA201451](/drug/anda-201451/) — original approval 2011-02-23
- [PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE — FDA application ANDA090575](/drug/anda-090575/) — original approval 2011-02-08
- [ONDANSETRON HYDROCHLORIDE — FDA application ANDA091483](/drug/anda-091483/) — original approval 2011-01-31
- [INDOMETHACIN — FDA application ANDA091549](/drug/anda-091549/) — original approval 2010-12-01
- [SPIRONOLACTONE — FDA application ANDA091426](/drug/anda-091426/) — original approval 2010-07-02
- [LORAZEPAM — FDA application ANDA078826](/drug/anda-078826/) — original approval 2010-06-23
- [ALBUTEROL SULFATE — FDA application ANDA079241](/drug/anda-079241/) — original approval 2010-05-12
- [VENLAFAXINE HYDROCHLORIDE — FDA application ANDA079098](/drug/anda-079098/) — original approval 2010-05-11
- [PROMETHAZINE HYDROCHLORIDE — FDA application ANDA040882](/drug/anda-040882/) — original approval 2009-12-30
- [LORAZEPAM — FDA application ANDA091383](/drug/anda-091383/) — original approval 2009-12-23
- [TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN — FDA application ANDA090485](/drug/anda-090485/) — original approval 2009-12-09
- [NIZATIDINE — FDA application ANDA090576](/drug/anda-090576/) — original approval 2009-11-18
- [LEVETIRACETAM — FDA application ANDA090992](/drug/anda-090992/) — original approval 2009-10-27
- [CETIRIZINE HYDROCHLORIDE — FDA application ANDA090766](/drug/anda-090766/) — original approval 2009-10-07
- [CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY / CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF — FDA application ANDA090765](/drug/anda-090765/) — original approval 2009-10-07
- [NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE — FDA application ANDA078267](/drug/anda-078267/) — original approval 2009-09-01
- [PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE — FDA application ANDA040902](/drug/anda-040902/) — original approval 2009-08-25
- [PREDNISOLONE SODIUM PHOSPHATE — FDA application ANDA078345](/drug/anda-078345/) — original approval 2009-03-10
- [RANITIDINE HYDROCHLORIDE — FDA application ANDA078312](/drug/anda-078312/) — original approval 2008-09-02
- [OXYCODONE AND ACETAMINOPHEN — FDA application ANDA040777](/drug/anda-040777/) — original approval 2007-11-27
- [BENAZEPRIL HYDROCHLORIDE — FDA application ANDA076820](/drug/anda-076820/) — original approval 2006-02-03
- [TRAMADOL HYDROCHLORIDE — FDA application ANDA076003](/drug/anda-076003/) — original approval 2002-06-20

## ANIP — ANI PHARMACEUTICALS INC

- [NITAZOXANIDE — FDA application ANDA214844](/drug/anda-214844/) — original approval 2025-02-03
- [CARBOPROST TROMETHAMINE — FDA application ANDA215901](/drug/anda-215901/) — original approval 2024-01-25
- [MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE — FDA application ANDA208237](/drug/anda-208237/) — original approval 2023-12-15
- [BACLOFEN — FDA application ANDA217252](/drug/anda-217252/) — original approval 2023-06-08
- [COLESTIPOL HYDROCHLORIDE — FDA application ANDA216517](/drug/anda-216517/) — original approval 2023-03-10
- [FESOTERODINE FUMARATE — FDA application ANDA204504](/drug/anda-204504/) — original approval 2023-01-04
- [LEVOTHYROXINE SODIUM — FDA application ANDA213256](/drug/anda-213256/) — original approval 2021-01-06
- [AMINOCAPROIC ACID — FDA application ANDA211629](/drug/anda-211629/) — original approval 2020-12-14
- [LEVOTHYROXINE SODIUM — FDA application ANDA211369](/drug/anda-211369/) — original approval 2020-10-28
- [MEMANTINE HYDROCHLORIDE — FDA application ANDA205365](/drug/anda-205365/) — original approval 2020-02-28
- [POTASSIUM CITRATE — FDA application ANDA212779](/drug/anda-212779/) — original approval 2020-01-14
- [RANOLAZINE — FDA application ANDA210482](/drug/anda-210482/) — original approval 2019-10-29
- [LUXZYLA — FDA application ANDA209921](/drug/anda-209921/) — original approval 2019-05-07
- [DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE — FDA application ANDA205401](/drug/anda-205401/) — original approval 2019-01-22
- [BEXAROTENE — FDA application ANDA209861](/drug/anda-209861/) — original approval 2018-05-08
- [FENOFIBRATE (MICRONIZED) — FDA application ANDA209504](/drug/anda-209504/) — original approval 2018-04-30
- [MIGLUSTAT — FDA application ANDA208342](/drug/anda-208342/) — original approval 2018-04-17
- [MORPHINE SULFATE — FDA application ANDA205509](/drug/anda-205509/) — original approval 2018-04-17
- [CYCLOPHOSPHAMIDE — FDA application ANDA207014](/drug/anda-207014/) — original approval 2018-03-19
- [OXYCODONE HYDROCHLORIDE — FDA application ANDA203447](/drug/anda-203447/) — original approval 2017-08-30
- [METHYLPHENIDATE HYDROCHLORIDE — FDA application ANDA208607](/drug/anda-208607/) — original approval 2017-07-14
- [EZETIMIBE AND SIMVASTATIN — FDA application ANDA201890](/drug/anda-201890/) — original approval 2017-04-26
- [ASPIRIN AND DIPYRIDAMOLE — FDA application ANDA206964](/drug/anda-206964/) — original approval 2017-01-18
- [DESIPRAMINE HYDROCHLORIDE — FDA application ANDA205153](/drug/anda-205153/) — original approval 2016-10-28
- [TRANEXAMIC ACID — FDA application ANDA203256](/drug/anda-203256/) — original approval 2016-07-25
- [NILUTAMIDE — FDA application ANDA207631](/drug/anda-207631/) — original approval 2016-07-15
- [TEMOZOLOMIDE — FDA application ANDA203490](/drug/anda-203490/) — original approval 2016-07-13
- [OXYCODONE HYDROCHLORIDE — FDA application ANDA205177](/drug/anda-205177/) — original approval 2016-03-31
- [POLYETHYLENE GLYCOL 3350 — FDA application ANDA202850](/drug/anda-202850/) — original approval 2015-12-15
- [FELBAMATE — FDA application ANDA202284](/drug/anda-202284/) — original approval 2015-11-04
- [OXYCODONE HYDROCHLORIDE — FDA application ANDA204979](/drug/anda-204979/) — original approval 2015-06-01
- [NEBIVOLOL HYDROCHLORIDE — FDA application ANDA203659](/drug/anda-203659/) — original approval 2015-04-16
- [CARBIDOPA — FDA application ANDA203261](/drug/anda-203261/) — original approval 2014-03-10
- [ZOLMITRIPTAN — FDA application ANDA090861](/drug/anda-090861/) — original approval 2014-03-04
- [LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) — FDA application ANDA200218](/drug/anda-200218/) — original approval 2013-08-30
- [ROSIGLITAZONE MALEATE — FDA application ANDA076747](/drug/anda-076747/) — original approval 2013-01-25
- [CLOPIDOGREL BISULFATE — FDA application ANDA091216](/drug/anda-091216/) — original approval 2012-05-17
- [CLOPIDOGREL BISULFATE — FDA application ANDA090625](/drug/anda-090625/) — original approval 2012-05-17
- [TESTOSTERONE — FDA application NDA202763](/drug/nda-202763/) — original approval 2012-02-14
- [CARBAMAZEPINE — FDA application ANDA076697](/drug/anda-076697/) — original approval 2011-05-20
- [SODIUM POLYSTYRENE SULFONATE — FDA application ANDA090590](/drug/anda-090590/) — original approval 2011-05-13
- [FLUCONAZOLE — FDA application ANDA078423](/drug/anda-078423/) — original approval 2011-03-07
- [CIPROFLOXACIN EXTENDED RELEASE — FDA application ANDA077809](/drug/anda-077809/) — original approval 2010-11-30
- [LANSOPRAZOLE — FDA application ANDA078730](/drug/anda-078730/) — original approval 2010-10-15
- [NARATRIPTAN — FDA application ANDA078751](/drug/anda-078751/) — original approval 2010-07-07
- [HYDROCODONE BITARTRATE AND IBUPROFEN — FDA application ANDA077454](/drug/anda-077454/) — original approval 2010-06-23
- [PERINDOPRIL ERBUMINE — FDA application ANDA078138](/drug/anda-078138/) — original approval 2009-11-10
- [RISPERIDONE — FDA application ANDA076440](/drug/anda-076440/) — original approval 2009-01-30
- [LACTULOSE — FDA application ANDA090426](/drug/anda-090426/) — original approval 2008-11-21
- [FLUOXETINE HYDROCHLORIDE — FDA application ANDA076287](/drug/anda-076287/) — original approval 2008-05-20
- [LUVOX — FDA application NDA021519](/drug/nda-021519/) — original approval 2007-12-20
- [OXCARBAZEPINE — FDA application ANDA078005](/drug/anda-078005/) — original approval 2007-12-11
- [LACTULOSE — FDA application ANDA078430](/drug/anda-078430/) — original approval 2007-11-28
- [KIONEX — FDA application ANDA040028](/drug/anda-040028/) — original approval 2007-09-17
- [QUINAPRIL HYDROCHLORIDE — FDA application ANDA075504](/drug/anda-075504/) — original approval 2007-08-24
- [ALPRAZOLAM — FDA application ANDA077979](/drug/anda-077979/) — original approval 2007-02-28
- [LORAZEPAM — FDA application ANDA077396](/drug/anda-077396/) — original approval 2006-12-13
- [VEREGEN — FDA application NDA021902](/drug/nda-021902/) — original approval 2006-10-31
- [ALPRAZOLAM — FDA application ANDA077725](/drug/anda-077725/) — original approval 2006-07-31
- [CEFADROXIL — FDA application ANDA065278](/drug/anda-065278/) — original approval 2006-01-20
- [ZONISAMIDE — FDA application ANDA077641](/drug/anda-077641/) — original approval 2005-12-22
- [ZONISAMIDE — FDA application ANDA077639](/drug/anda-077639/) — original approval 2005-12-22
- [RANITIDINE HYDROCHLORIDE — FDA application ANDA077426](/drug/anda-077426/) — original approval 2005-12-19
- [CLARITHROMYCIN — FDA application ANDA065250](/drug/anda-065250/) — original approval 2005-08-25
- [FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE — FDA application ANDA077144](/drug/anda-077144/) — original approval 2005-08-16
- [FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE — FDA application ANDA076608](/drug/anda-076608/) — original approval 2004-12-03
- [CEFUROXIME AXETIL — FDA application ANDA065190](/drug/anda-065190/) — original approval 2004-10-18
- [TIZANIDINE HYDROCHLORIDE — FDA application ANDA076321](/drug/anda-076321/) — original approval 2004-09-30
- [FLUCONAZOLE — FDA application ANDA076086](/drug/anda-076086/) — original approval 2004-07-29
- [PROPAFENONE HYDROCHLORIDE — FDA application ANDA076550](/drug/anda-076550/) — original approval 2004-04-23
- [BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — FDA application ANDA076348](/drug/anda-076348/) — original approval 2004-02-11
- [BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — FDA application ANDA076342](/drug/anda-076342/) — original approval 2004-02-11
- [BENAZEPRIL HYDROCHLORIDE — FDA application ANDA076333](/drug/anda-076333/) — original approval 2004-02-11
- [METOLAZONE — FDA application ANDA075543](/drug/anda-075543/) — original approval 2003-12-24
- [PYRIDOSTIGMINE BROMIDE — FDA application ANDA040512](/drug/anda-040512/) — original approval 2003-10-08
- [NEFAZODONE HYDROCHLORIDE — FDA application ANDA076072](/drug/anda-076072/) — original approval 2003-09-16
- [EXTENDED PHENYTOIN SODIUM — FDA application ANDA040435](/drug/anda-040435/) — original approval 2003-06-20
- [TIZANIDINE HYDROCHLORIDE — FDA application ANDA076371](/drug/anda-076371/) — original approval 2003-04-09
- [INNOPRAN XL — FDA application NDA021438](/drug/nda-021438/) — original approval 2003-03-12
- [DIFLORASONE DIACETATE — FDA application ANDA076263](/drug/anda-076263/) — original approval 2002-12-20
- [FLECAINIDE ACETATE — FDA application ANDA076030](/drug/anda-076030/) — original approval 2002-10-28
- [FLECAINIDE ACETATE — FDA application ANDA075882](/drug/anda-075882/) — original approval 2002-10-28
- [NIZATIDINE — FDA application ANDA075668](/drug/anda-075668/) — original approval 2002-09-12
- [ETODOLAC — FDA application ANDA075943](/drug/anda-075943/) — original approval 2002-07-26
- [TIZANIDINE HYDROCHLORIDE — FDA application ANDA076283](/drug/anda-076283/) — original approval 2002-07-12
- [MISOPROSTOL — FDA application ANDA076095](/drug/anda-076095/) — original approval 2002-07-10
- [NIZATIDINE — FDA application ANDA075461](/drug/anda-075461/) — original approval 2002-07-08
- [TIZANIDINE HYDROCHLORIDE — FDA application ANDA076284](/drug/anda-076284/) — original approval 2002-07-03
- [CLOBETASOL PROPIONATE (EMOLLIENT) — FDA application ANDA075733](/drug/anda-075733/) — original approval 2001-08-22
- [FLUVOXAMINE MALEATE — FDA application ANDA075898](/drug/anda-075898/) — original approval 2001-03-12
- [FLUVOXAMINE MALEATE — FDA application ANDA075897](/drug/anda-075897/) — original approval 2001-01-25
- [DOXAZOSIN MESYLATE — FDA application ANDA075432](/drug/anda-075432/) — original approval 2000-10-18
- [ATACAND HCT — FDA application NDA021093](/drug/nda-021093/) — original approval 2000-09-05
- [RANITIDINE HYDROCHLORIDE — FDA application ANDA075296](/drug/anda-075296/) — original approval 2000-01-14
- [RANITIDINE HYDROCHLORIDE — FDA application ANDA075212](/drug/anda-075212/) — original approval 2000-01-14
- [ETODOLAC — FDA application ANDA075126](/drug/anda-075126/) — original approval 1999-09-16
- [PENTOXIFYLLINE — FDA application ANDA075199](/drug/anda-075199/) — original approval 1999-09-03
- [LEUCOVORIN CALCIUM — FDA application ANDA075327](/drug/anda-075327/) — original approval 1999-03-24
- [INDAPAMIDE — FDA application ANDA075201](/drug/anda-075201/) — original approval 1998-12-04
- [ISOSORBIDE MONONITRATE — FDA application ANDA075147](/drug/anda-075147/) — original approval 1998-11-27
- [PENTOXIFYLLINE — FDA application ANDA075107](/drug/anda-075107/) — original approval 1998-09-04
- [CIMETIDINE HYDROCHLORIDE — FDA application ANDA074859](/drug/anda-074859/) — original approval 1998-07-09
- [CIMETIDINE HYDROCHLORIDE — FDA application ANDA075110](/drug/anda-075110/) — original approval 1998-06-18
- [ATACAND — FDA application NDA020838](/drug/nda-020838/) — original approval 1998-06-04
- [OXYCODONE AND ASPIRIN — FDA application ANDA040255](/drug/anda-040255/) — original approval 1998-02-27
- [KIONEX — FDA application ANDA040029](/drug/anda-040029/) — original approval 1998-02-06
- [TRIAMTERENE AND HYDROCHLOROTHIAZIDE — FDA application ANDA074970](/drug/anda-074970/) — original approval 1998-01-06
- [ETODOLAC — FDA application ANDA074844](/drug/anda-074844/) — original approval 1997-12-23
- [ETODOLAC — FDA application ANDA074840](/drug/anda-074840/) — original approval 1997-08-29
- [RANITIDINE HYDROCHLORIDE — FDA application ANDA074488](/drug/anda-074488/) — original approval 1997-07-31
- [PENTOXIFYLLINE — FDA application ANDA074878](/drug/anda-074878/) — original approval 1997-07-09
- [ETODOLAC — FDA application ANDA074899](/drug/anda-074899/) — original approval 1997-07-08
- [DESIPRAMINE HYDROCHLORIDE — FDA application ANDA071803](/drug/anda-071803/) — original approval 1997-05-29
- [PANDEL — FDA application NDA020453](/drug/nda-020453/) — original approval 1997-02-28
- [PROCAINAMIDE HYDROCHLORIDE — FDA application ANDA040111](/drug/anda-040111/) — original approval 1996-12-13
- [NICARDIPINE HYDROCHLORIDE — FDA application ANDA074439](/drug/anda-074439/) — original approval 1996-12-10
- [INDAPAMIDE — FDA application ANDA074498](/drug/anda-074498/) — original approval 1996-10-31
- [NICARDIPINE HYDROCHLORIDE — FDA application ANDA074670](/drug/anda-074670/) — original approval 1996-10-28
- [NICARDIPINE HYDROCHLORIDE — FDA application ANDA074540](/drug/anda-074540/) — original approval 1996-10-28
- [CHOLESTYRAMINE — FDA application ANDA074554](/drug/anda-074554/) — original approval 1996-10-02
- [CIMETIDINE HYDROCHLORIDE — FDA application ANDA074610](/drug/anda-074610/) — original approval 1996-09-26
- [DIFLUNISAL — FDA application ANDA074604](/drug/anda-074604/) — original approval 1996-06-10
- [MEXILETINE HYDROCHLORIDE — FDA application ANDA074450](/drug/anda-074450/) — original approval 1996-05-16
- [GLIPIZIDE — FDA application ANDA074387](/drug/anda-074387/) — original approval 1996-03-04
- [TRIAMTERENE AND HYDROCHLOROTHIAZIDE — FDA application ANDA073467](/drug/anda-073467/) — original approval 1996-01-31
- [ARIMIDEX — FDA application NDA020541](/drug/nda-020541/) — original approval 1995-12-27
- [ACEBUTOLOL HYDROCHLORIDE — FDA application ANDA074007](/drug/anda-074007/) — original approval 1995-10-18
- [CASODEX — FDA application NDA020498](/drug/nda-020498/) — original approval 1995-10-04
- [GLIPIZIDE — FDA application ANDA074497](/drug/anda-074497/) — original approval 1995-08-31
- [INDAPAMIDE — FDA application ANDA074299](/drug/anda-074299/) — original approval 1995-07-27
- [CARBIDOPA AND LEVODOPA — FDA application ANDA073587](/drug/anda-073587/) — original approval 1995-06-29
- [GUANABENZ ACETATE — FDA application ANDA074149](/drug/anda-074149/) — original approval 1995-04-07
- [TRIAMTERENE AND HYDROCHLOROTHIAZIDE — FDA application ANDA074259](/drug/anda-074259/) — original approval 1995-03-30
- [TETRACYCLINE HYDROCHLORIDE — FDA application ANDA061471](/drug/anda-061471/) — original approval 1994-09-16
- [GUANABENZ ACETATE — FDA application ANDA074267](/drug/anda-074267/) — original approval 1994-06-01
- [ALPRAZOLAM — FDA application ANDA074085](/drug/anda-074085/) — original approval 1994-02-16
- [METHAZOLAMIDE — FDA application ANDA040001](/drug/anda-040001/) — original approval 1993-06-30
- [METOCLOPRAMIDE HYDROCHLORIDE — FDA application ANDA071402](/drug/anda-071402/) — original approval 1993-06-25
- [FLUPHENAZINE HYDROCHLORIDE — FDA application ANDA081310](/drug/anda-081310/) — original approval 1993-04-29
- [PINDOLOL — FDA application ANDA073609](/drug/anda-073609/) — original approval 1993-03-29
- [NORTRIPTYLINE HYDROCHLORIDE — FDA application ANDA074054](/drug/anda-074054/) — original approval 1992-12-31
- [OXISTAT — FDA application NDA020209](/drug/nda-020209/) — original approval 1992-09-30
- [VALPROIC ACID — FDA application ANDA073178](/drug/anda-073178/) — original approval 1992-08-25
- [TOLMETIN SODIUM — FDA application ANDA073527](/drug/anda-073527/) — original approval 1992-06-30
- [TOLMETIN SODIUM — FDA application ANDA073519](/drug/anda-073519/) — original approval 1992-05-29
- [SULINDAC — FDA application ANDA072973](/drug/anda-072973/) — original approval 1992-02-28
- [CLEMASTINE FUMARATE — FDA application ANDA073282](/drug/anda-073282/) — original approval 1992-01-31
- [TOLMETIN SODIUM — FDA application ANDA073392](/drug/anda-073392/) — original approval 1992-01-24
- [TOLMETIN SODIUM — FDA application ANDA073308](/drug/anda-073308/) — original approval 1992-01-24
- [IBUPROFEN — FDA application ANDA072903](/drug/anda-072903/) — original approval 1991-12-19
- [IBUPROFEN — FDA application ANDA072901](/drug/anda-072901/) — original approval 1991-12-19
- [FLUPHENAZINE HYDROCHLORIDE — FDA application ANDA073058](/drug/anda-073058/) — original approval 1991-08-30
- [TIMOLOL MALEATE — FDA application ANDA072919](/drug/anda-072919/) — original approval 1991-07-31
- [TIMOLOL MALEATE — FDA application ANDA072918](/drug/anda-072918/) — original approval 1991-07-31
- [TIMOLOL MALEATE — FDA application ANDA072917](/drug/anda-072917/) — original approval 1991-07-31
- [DIPYRIDAMOLE — FDA application ANDA086944](/drug/anda-086944/) — original approval 1991-04-16
- [ERYTHROMYCIN STEARATE — FDA application ANDA063179](/drug/anda-063179/) — original approval 1990-05-15
- [PRAZOSIN HYDROCHLORIDE — FDA application ANDA072577](/drug/anda-072577/) — original approval 1989-04-10
- [CEFADROXIL — FDA application ANDA062698](/drug/anda-062698/) — original approval 1989-03-01
- [FENOPROFEN CALCIUM — FDA application ANDA072274](/drug/anda-072274/) — original approval 1988-05-02
- [PROPRANOLOL HYDROCHLORIDE — FDA application ANDA071977](/drug/anda-071977/) — original approval 1988-04-06
- [PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — FDA application ANDA072043](/drug/anda-072043/) — original approval 1988-03-14
- [FUROSEMIDE — FDA application ANDA071594](/drug/anda-071594/) — original approval 1988-02-09
- [ISOSORBIDE DINITRATE — FDA application ANDA086032](/drug/anda-086032/) — original approval 1988-01-07
- [THIORIDAZINE HYDROCHLORIDE — FDA application ANDA089603](/drug/anda-089603/) — original approval 1987-11-09
- [THIORIDAZINE HYDROCHLORIDE — FDA application ANDA089602](/drug/anda-089602/) — original approval 1987-11-09
- [PERPHENAZINE — FDA application ANDA089708](/drug/anda-089708/) — original approval 1987-09-10
- [PERPHENAZINE — FDA application ANDA089707](/drug/anda-089707/) — original approval 1987-09-10
- [PERPHENAZINE — FDA application ANDA089457](/drug/anda-089457/) — original approval 1987-09-10
- [PERPHENAZINE — FDA application ANDA089456](/drug/anda-089456/) — original approval 1987-09-10
- [PROCAINAMIDE HYDROCHLORIDE — FDA application ANDA089369](/drug/anda-089369/) — original approval 1987-08-14
- [PROPRANOLOL HYDROCHLORIDE — FDA application ANDA071791](/drug/anda-071791/) — original approval 1987-07-15
- [MECLOFENAMATE SODIUM — FDA application ANDA071469](/drug/anda-071469/) — original approval 1987-04-15
- [PROCAINAMIDE HYDROCHLORIDE — FDA application ANDA089438](/drug/anda-089438/) — original approval 1987-03-23
- [INDOMETHACIN — FDA application ANDA071149](/drug/anda-071149/) — original approval 1987-03-18
- [INDOMETHACIN — FDA application ANDA071148](/drug/anda-071148/) — original approval 1987-03-18
- [ACETOHEXAMIDE — FDA application ANDA070870](/drug/anda-070870/) — original approval 1987-02-09
- [IBUPROFEN — FDA application ANDA071144](/drug/anda-071144/) — original approval 1987-01-20
- [FUROSEMIDE — FDA application ANDA071379](/drug/anda-071379/) — original approval 1987-01-02
- [EXTENDED PHENYTOIN SODIUM — FDA application ANDA089441](/drug/anda-089441/) — original approval 1986-12-18
- [CHLORPROPAMIDE — FDA application ANDA089447](/drug/anda-089447/) — original approval 1986-11-17
- [CHLORPROPAMIDE — FDA application ANDA089446](/drug/anda-089446/) — original approval 1986-11-17
- [PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — FDA application ANDA070705](/drug/anda-070705/) — original approval 1986-10-01
- [PROCAINAMIDE HYDROCHLORIDE — FDA application ANDA089219](/drug/anda-089219/) — original approval 1986-07-01
- [FUROSEMIDE — FDA application ANDA070413](/drug/anda-070413/) — original approval 1986-02-26
- [DEXCHLORPHENIRAMINE MALEATE — FDA application ANDA088682](/drug/anda-088682/) — original approval 1986-01-17
- [MECLIZINE HYDROCHLORIDE — FDA application ANDA088732](/drug/anda-088732/) — original approval 1985-12-11
- [PROCAINAMIDE HYDROCHLORIDE — FDA application ANDA088959](/drug/anda-088959/) — original approval 1985-12-02
- [PROCAINAMIDE HYDROCHLORIDE — FDA application ANDA088958](/drug/anda-088958/) — original approval 1985-12-02
- [SULFAMETHOXAZOLE AND TRIMETHOPRIM — FDA application ANDA070028](/drug/anda-070028/) — original approval 1985-10-29
- [PROCAINAMIDE HYDROCHLORIDE — FDA application ANDA088974](/drug/anda-088974/) — original approval 1985-07-22
- [THIORIDAZINE HYDROCHLORIDE — FDA application ANDA088493](/drug/anda-088493/) — original approval 1985-05-17
- [THIORIDAZINE HYDROCHLORIDE — FDA application ANDA088456](/drug/anda-088456/) — original approval 1985-05-17
- [CHLORPROPAMIDE — FDA application ANDA088922](/drug/anda-088922/) — original approval 1985-04-12
- [CHLORPROPAMIDE — FDA application ANDA088921](/drug/anda-088921/) — original approval 1985-04-12
- [ACETAMINOPHEN AND CODEINE PHOSPHATE — FDA application ANDA088629](/drug/anda-088629/) — original approval 1985-03-06
- [CHLORPROPAMIDE — FDA application ANDA088840](/drug/anda-088840/) — original approval 1984-10-25
- [CHLORPROPAMIDE — FDA application ANDA088813](/drug/anda-088813/) — original approval 1984-10-19
- [CHLORPROPAMIDE — FDA application ANDA088812](/drug/anda-088812/) — original approval 1984-10-19
- [CHLORPROPAMIDE — FDA application ANDA088919](/drug/anda-088919/) — original approval 1984-10-16
- [CHLORPROPAMIDE — FDA application ANDA088918](/drug/anda-088918/) — original approval 1984-10-16
- [CHLORPROPAMIDE — FDA application ANDA088768](/drug/anda-088768/) — original approval 1984-10-11
- [GLUCAMIDE — FDA application ANDA088641](/drug/anda-088641/) — original approval 1984-10-11
- [CHLORPROPAMIDE — FDA application ANDA088826](/drug/anda-088826/) — original approval 1984-09-26
- [CHLORTHALIDONE — FDA application ANDA088164](/drug/anda-088164/) — original approval 1984-01-09
- [THIORIDAZINE HYDROCHLORIDE — FDA application ANDA088273](/drug/anda-088273/) — original approval 1983-10-03
- [VANCOCIN HYDROCHLORIDE — FDA application ANDA061667](/drug/anda-061667/) — original approval 1983-07-13
- [INDERAL LA — FDA application NDA018553](/drug/nda-018553/) — original approval 1983-04-19
- [THIORIDAZINE HYDROCHLORIDE — FDA application ANDA088272](/drug/anda-088272/) — original approval 1983-04-14
- [THIORIDAZINE HYDROCHLORIDE — FDA application ANDA088271](/drug/anda-088271/) — original approval 1983-04-14
- [THIORIDAZINE HYDROCHLORIDE — FDA application ANDA088270](/drug/anda-088270/) — original approval 1983-04-14
- [THIORIDAZINE HYDROCHLORIDE — FDA application ANDA088194](/drug/anda-088194/) — original approval 1983-04-14
- [QUINIDINE GLUCONATE — FDA application ANDA087810](/drug/anda-087810/) — original approval 1982-09-29
- [CHLORTHALIDONE — FDA application ANDA087706](/drug/anda-087706/) — original approval 1981-09-16
- [CHLORTHALIDONE — FDA application ANDA087689](/drug/anda-087689/) — original approval 1981-09-16
- [CHLORTHALIDONE — FDA application ANDA087296](/drug/anda-087296/) — original approval 1981-08-19
- [CHLORPROPAMIDE — FDA application ANDA087353](/drug/anda-087353/) — original approval 1981-06-26
- [REGLAN — FDA application NDA017854](/drug/nda-017854/) — original approval 1980-12-30
- [ERYTHROMYCIN STEARATE — FDA application ANDA061461](/drug/anda-061461/) — original approval 1980-04-11
- [TOLBUTAMIDE — FDA application ANDA087093](/drug/anda-087093/) — original approval 1980-03-25
- [OXACILLIN SODIUM — FDA application ANDA062222](/drug/anda-062222/) — original approval 1980-03-10
- [DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE — FDA application ANDA086727](/drug/anda-086727/) — original approval 1979-10-29
- [LITHOBID — FDA application NDA018027](/drug/nda-018027/) — original approval 1979-04-27
- [ERYTHROMYCIN ETHYLSUCCINATE — FDA application ANDA062055](/drug/anda-062055/) — original approval 1978-11-27
- [PROBENECID AND COLCHICINE — FDA application ANDA083734](/drug/anda-083734/) — original approval 1978-06-12
- [PROMPT PHENYTOIN SODIUM — FDA application ANDA080259](/drug/anda-080259/) — original approval 1978-04-06
- [MECLIZINE HYDROCHLORIDE — FDA application ANDA085740](/drug/anda-085740/) — original approval 1977-07-06
- [METHOCARBAMOL — FDA application ANDA084277](/drug/anda-084277/) — original approval 1977-03-14
- [METHOCARBAMOL — FDA application ANDA084276](/drug/anda-084276/) — original approval 1977-01-04
- [AMINOPHYLLINE — FDA application ANDA085261](/drug/anda-085261/) — original approval 1976-12-22
- [AMITRIPTYLINE HYDROCHLORIDE — FDA application ANDA085032](/drug/anda-085032/) — original approval 1976-11-19
- [AMITRIPTYLINE HYDROCHLORIDE — FDA application ANDA085031](/drug/anda-085031/) — original approval 1976-11-16
- [MECLIZINE HYDROCHLORIDE — FDA application ANDA085269](/drug/anda-085269/) — original approval 1976-11-11
- [BRETHINE — FDA application NDA017849](/drug/nda-017849/) — original approval 1976-05-17
- [MECLIZINE HYDROCHLORIDE — FDA application ANDA084657](/drug/anda-084657/) — original approval 1975-12-01
- [SULFISOXAZOLE — FDA application ANDA080142](/drug/anda-080142/) — original approval 1974-03-06
- [ERYTHROMYCIN STEARATE — FDA application ANDA061591](/drug/anda-061591/) — original approval 1972-09-08
- [CORTENEMA — FDA application NDA016199](/drug/nda-016199/) — original approval 1966-01-12
- [TENUATE DOSPAN — FDA application NDA012546](/drug/nda-012546/) — original approval 1960-11-17
- [PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE — FDA application NDA011265](/drug/nda-011265/) — original approval 1957-12-03
- [CORTROPHIN-ZINC — FDA application NDA009854](/drug/nda-009854/) — original approval 1955-07-29
- [PHENERGAN VC — FDA application NDA008604](/drug/nda-008604/) — original approval 1954-09-14
- [PURIFIED CORTROPHIN GEL — FDA application NDA008975](/drug/nda-008975/) — original approval 1954-06-16
- [PROMETHAZINE HYDROCHLORIDE PLAIN — FDA application NDA008381](/drug/nda-008381/) — original approval 1952-04-11
- [PHENERGAN VC W/ CODEINE / PHENERGAN W/ CODEINE — FDA application NDA008306](/drug/nda-008306/) — original approval 1952-01-21

## ARDX — ARDELYX, INC.

- [XPHOZAH — FDA application NDA213931](/drug/nda-213931/) — original approval 2023-10-17
- [IBSRELA — FDA application NDA211801](/drug/nda-211801/) — original approval 2019-09-12

## BBIO — BridgeBio Pharma, Inc.

- [ATTRUBY — FDA application NDA216540](/drug/nda-216540/) — original approval 2024-11-22

## BIIB — BIOGEN INC.

- [ZURZUVAE — FDA application NDA217369](/drug/nda-217369/) — original approval 2023-08-04
- [ADUHELM — FDA application BLA761178](/drug/bla-761178/) — original approval 2021-06-07
- [VUMERITY — FDA application NDA211855](/drug/nda-211855/) — original approval 2019-10-29
- [SPINRAZA — FDA application NDA209531](/drug/nda-209531/) — original approval 2016-12-23
- [ZINBRYTA — FDA application BLA761029](/drug/bla-761029/) — original approval 2016-05-27
- [TECFIDERA — FDA application NDA204063](/drug/nda-204063/) — original approval 2013-03-27
- [AVONEX — FDA application BLA103628](/drug/bla-103628/) — original approval 1996-05-17

## BMY — BRISTOL MYERS SQUIBB CO

- [OPDIVO QVANTIG — FDA application BLA761429](/drug/bla-761429/) — original approval 2024-12-27
- [OPDIVO QVANTIG — FDA application BLA761381](/drug/bla-761381/) — original approval 2024-12-27
- [OPDUALAG — FDA application BLA761234](/drug/bla-761234/) — original approval 2022-03-18
- [IDHIFA — FDA application NDA209606](/drug/nda-209606/) — original approval 2017-08-01
- [EMPLICITI — FDA application BLA761035](/drug/bla-761035/) — original approval 2015-11-30
- [DAKLINZA — FDA application NDA206843](/drug/nda-206843/) — original approval 2015-07-24
- [OPDIVO — FDA application BLA125527](/drug/bla-125527/) — original approval 2015-03-04
- [OPDIVO — FDA application BLA125554](/drug/bla-125554/) — original approval 2014-12-22
- [REYATAZ — FDA application NDA206352](/drug/nda-206352/) — original approval 2014-06-02
- [ELIQUIS — FDA application NDA202155](/drug/nda-202155/) — original approval 2012-12-28
- [NULOJIX — FDA application BLA125288](/drug/bla-125288/) — original approval 2011-06-15
- [YERVOY — FDA application BLA125377](/drug/bla-125377/) — original approval 2011-03-25
- [SPRYCEL — FDA application NDA022072](/drug/nda-022072/) — original approval 2006-06-28
- [SPRYCEL — FDA application NDA021986](/drug/nda-021986/) — original approval 2006-06-28
- [REVLIMID — FDA application NDA021880](/drug/nda-021880/) — original approval 2005-12-27
- [ORENCIA — FDA application BLA125118](/drug/bla-125118/) — original approval 2005-12-23
- [BARACLUDE — FDA application NDA021798](/drug/nda-021798/) — original approval 2005-03-29
- [BARACLUDE — FDA application NDA021797](/drug/nda-021797/) — original approval 2005-03-29
- [PRAVIGARD PAC (COPACKAGED) — FDA application NDA021387](/drug/nda-021387/) — original approval 2003-06-24
- [REYATAZ — FDA application NDA021567](/drug/nda-021567/) — original approval 2003-06-20
- [ZERIT XR — FDA application NDA021453](/drug/nda-021453/) — original approval 2002-12-31
- [METAGLIP — FDA application NDA021460](/drug/nda-021460/) — original approval 2002-10-21
- [SUSTIVA — FDA application NDA021360](/drug/nda-021360/) — original approval 2002-02-01
- [BUSPAR — FDA application NDA021190](/drug/nda-021190/) — original approval 2000-12-20
- [VIDEX EC — FDA application NDA021183](/drug/nda-021183/) — original approval 2000-10-31
- [GLUCOVANCE — FDA application NDA021178](/drug/nda-021178/) — original approval 2000-07-31
- [SUSTIVA — FDA application NDA020972](/drug/nda-020972/) — original approval 1998-09-17
- [ETOPOPHOS PRESERVATIVE FREE — FDA application NDA020906](/drug/nda-020906/) — original approval 1998-02-27
- [SERZONE — FDA application NDA020152](/drug/nda-020152/) — original approval 1994-12-22
- [MONOPRIL-HCT — FDA application NDA020286](/drug/nda-020286/) — original approval 1994-11-30
- [MEGACE — FDA application NDA020264](/drug/nda-020264/) — original approval 1993-09-10
- [ESTRACE — FDA application ANDA081295](/drug/anda-081295/) — original approval 1993-06-30
- [STADOL — FDA application NDA019890](/drug/nda-019890/) — original approval 1991-12-12
- [PRAVACHOL — FDA application NDA019898](/drug/nda-019898/) — original approval 1991-10-31
- [VIDEX — FDA application NDA020155](/drug/nda-020155/) — original approval 1991-10-09
- [VIDEX — FDA application NDA020154](/drug/nda-020154/) — original approval 1991-10-09
- [MONOPRIL — FDA application NDA019915](/drug/nda-019915/) — original approval 1991-05-16
- [AZACTAM IN PLASTIC CONTAINER — FDA application NDA050632](/drug/nda-050632/) — original approval 1989-05-24
- [MEXATE-AQ PRESERVED — FDA application ANDA089887](/drug/anda-089887/) — original approval 1989-04-14
- [RUBEX — FDA application ANDA062926](/drug/anda-062926/) — original approval 1989-04-13
- [NARCAN — FDA application ANDA071311](/drug/anda-071311/) — original approval 1988-07-28
- [NARCAN — FDA application ANDA071084](/drug/anda-071084/) — original approval 1988-07-28
- [NARCAN — FDA application ANDA071083](/drug/anda-071083/) — original approval 1988-07-28
- [VINCREX — FDA application ANDA070867](/drug/anda-070867/) — original approval 1988-07-12
- [BUSPAR — FDA application NDA018731](/drug/nda-018731/) — original approval 1986-09-29
- [AMITID — FDA application ANDA086454](/drug/anda-086454/) — original approval 1978-10-19
- [GLUCOSCAN — FDA application NDA017907](/drug/nda-017907/) — original approval 1978-05-25
- [OXYCODONE 5/APAP 500 — FDA application ANDA085911](/drug/anda-085911/) — original approval 1977-10-25
- [OXYCODONE 2.5/APAP 500 — FDA application ANDA085910](/drug/anda-085910/) — original approval 1977-10-25
- [ESTRACE — FDA application ANDA084499](/drug/anda-084499/) — original approval 1975-07-28
- [ESTRACE — FDA application ANDA084500](/drug/anda-084500/) — original approval 1975-07-23
- [BLENOXANE — FDA application NDA050443](/drug/nda-050443/) — original approval 1973-07-31
- [PROLIXIN DECANOATE — FDA application NDA016727](/drug/nda-016727/) — original approval 1972-06-20
- [MEGACE — FDA application NDA016979](/drug/nda-016979/) — original approval 1971-08-18
- [FUNGIZONE — FDA application NDA050341](/drug/nda-050341/) — original approval 1971-06-02
- [PRINCIPEN — FDA application ANDA061392](/drug/anda-061392/) — original approval 1971-03-03
- [TESLAC — FDA application NDA016118](/drug/nda-016118/) — original approval 1970-05-27
- [TESLAC — FDA application NDA016119](/drug/nda-016119/) — original approval 1969-06-03
- [VESPRIN — FDA application NDA011123](/drug/nda-011123/) — original approval 1957-09-16
- [COUMADIN — FDA application NDA009218](/drug/nda-009218/) — original approval 1954-06-08
- [RUBRAMIN PC — FDA application NDA006799](/drug/nda-006799/) — original approval 1950-09-29
- [TUBOCURARINE CHLORIDE — FDA application NDA005657](/drug/nda-005657/) — original approval 1945-02-20

## CPRX — CATALYST PHARMACEUTICALS, INC.

- [AGAMREE — FDA application NDA215239](/drug/nda-215239/) — original approval 2023-10-26
- [FIRDAPSE — FDA application NDA208078](/drug/nda-208078/) — original approval 2018-11-28
- [FYCOMPA — FDA application NDA208277](/drug/nda-208277/) — original approval 2016-04-29
- [FYCOMPA — FDA application NDA202834](/drug/nda-202834/) — original approval 2012-10-22

## CRMD — CorMedix Inc.

- [DEFENCATH — FDA application NDA214520](/drug/nda-214520/) — original approval 2023-11-15

## CYTK — CYTOKINETICS INC

- [MYQORZO — FDA application NDA219083](/drug/nda-219083/) — original approval 2025-12-19

## DNLI — Denali Therapeutics Inc.

- [AVLAYAH — FDA application BLA761485](/drug/bla-761485/) — original approval 2026-03-24

## EOLS — Evolus, Inc.

- [JEUVEAU — FDA application BLA761085](/drug/bla-761085/) — original approval 2019-02-01

## EXEL — EXELIXIS, INC.

- [CABOMETYX — FDA application NDA208692](/drug/nda-208692/) — original approval 2016-04-25
- [COMETRIQ — FDA application NDA203756](/drug/nda-203756/) — original approval 2012-11-29

## FENC — FENNEC PHARMACEUTICALS INC.

- [PEDMARK — FDA application NDA212937](/drug/nda-212937/) — original approval 2022-09-20

## GERN — GERON CORP

- [RYTELO — FDA application NDA217779](/drug/nda-217779/) — original approval 2024-06-06

## GILD — GILEAD SCIENCES, INC.

- [HEPCLUDEX — FDA application BLA761468](/drug/bla-761468/) — original approval 2026-05-22
- [YEZTUGO — FDA application NDA220020](/drug/nda-220020/) — original approval 2025-06-18
- [YEZTUGO — FDA application NDA220018](/drug/nda-220018/) — original approval 2025-06-18
- [LIVDELZI — FDA application NDA217899](/drug/nda-217899/) — original approval 2024-08-14
- [SUNLENCA — FDA application NDA215974](/drug/nda-215974/) — original approval 2022-12-22
- [SUNLENCA — FDA application NDA215973](/drug/nda-215973/) — original approval 2022-12-22
- [EPCLUSA — FDA application NDA214187](/drug/nda-214187/) — original approval 2021-06-10
- [VEKLURY — FDA application NDA214787](/drug/nda-214787/) — original approval 2020-10-22
- [SOVALDI — FDA application NDA212480](/drug/nda-212480/) — original approval 2019-08-28
- [HARVONI — FDA application NDA212477](/drug/nda-212477/) — original approval 2019-08-28
- [BIKTARVY — FDA application NDA210251](/drug/nda-210251/) — original approval 2018-02-07
- [VOSEVI — FDA application NDA209195](/drug/nda-209195/) — original approval 2017-07-18
- [VEMLIDY — FDA application NDA208464](/drug/nda-208464/) — original approval 2016-11-10
- [EPCLUSA — FDA application NDA208341](/drug/nda-208341/) — original approval 2016-06-28
- [DESCOVY — FDA application NDA208215](/drug/nda-208215/) — original approval 2016-04-04
- [ODEFSEY — FDA application NDA208351](/drug/nda-208351/) — original approval 2016-03-01
- [GENVOYA — FDA application NDA207561](/drug/nda-207561/) — original approval 2015-11-05
- [HARVONI — FDA application NDA205834](/drug/nda-205834/) — original approval 2014-10-10
- [TYBOST — FDA application NDA203094](/drug/nda-203094/) — original approval 2014-09-24
- [VITEKTA — FDA application NDA203093](/drug/nda-203093/) — original approval 2014-09-24
- [ZYDELIG — FDA application NDA206545](/drug/nda-206545/) — original approval 2014-07-23
- [ZYDELIG — FDA application NDA205858](/drug/nda-205858/) — original approval 2014-07-23
- [SOVALDI — FDA application NDA204671](/drug/nda-204671/) — original approval 2013-12-06
- [STRIBILD — FDA application NDA203100](/drug/nda-203100/) — original approval 2012-08-27
- [VIREAD — FDA application NDA022577](/drug/nda-022577/) — original approval 2012-01-18
- [COMPLERA — FDA application NDA202123](/drug/nda-202123/) — original approval 2011-08-10
- [ATRIPLA — FDA application NDA021937](/drug/nda-021937/) — original approval 2006-07-12
- [VIREAD — FDA application NDA021356](/drug/nda-021356/) — original approval 2001-10-26
- [VISTIDE — FDA application NDA020638](/drug/nda-020638/) — original approval 1996-06-26

## INCY — INCYTE CORP

- [JAKAFI XR — FDA application NDA217180](/drug/nda-217180/) — original approval 2026-05-01
- [NIKTIMVO — FDA application BLA761411](/drug/bla-761411/) — original approval 2024-08-14
- [ZYNYZ — FDA application BLA761334](/drug/bla-761334/) — original approval 2023-03-22
- [OPZELURA — FDA application NDA215309](/drug/nda-215309/) — original approval 2021-09-21
- [PEMAZYRE — FDA application NDA213736](/drug/nda-213736/) — original approval 2020-04-17
- [JAKAFI — FDA application NDA202192](/drug/nda-202192/) — original approval 2011-11-16

## INSM — INSMED Inc

- [BRINSUPRI — FDA application NDA217673](/drug/nda-217673/) — original approval 2025-08-12
- [ARIKAYCE KIT — FDA application NDA207356](/drug/nda-207356/) — original approval 2018-09-28
- [IPLEX — FDA application BLA021884](/drug/bla-021884/) — original approval 2005-12-12

## IONS — IONIS PHARMACEUTICALS INC

- [DAWNZERA (AUTOINJECTOR) — FDA application NDA219407](/drug/nda-219407/) — original approval 2025-08-21
- [TRYNGOLZA (AUTOINJECTOR) — FDA application NDA218614](/drug/nda-218614/) — original approval 2024-12-19

## IRWD — IRONWOOD PHARMACEUTICALS INC

- [DUZALLO — FDA application NDA209203](/drug/nda-209203/) — original approval 2017-08-18
- [ZURAMPIC — FDA application NDA207988](/drug/nda-207988/) — original approval 2015-12-22

## JAZZ — Jazz Pharmaceuticals plc

- [ZIIHERA — FDA application BLA761416](/drug/bla-761416/) — original approval 2024-11-20
- [RYLAZE — FDA application BLA761179](/drug/bla-761179/) — original approval 2021-06-30
- [DEFITELIO — FDA application NDA208114](/drug/nda-208114/) — original approval 2016-03-30
- [LUVOX CR — FDA application NDA022033](/drug/nda-022033/) — original approval 2008-02-28
- [XYREM — FDA application NDA021196](/drug/nda-021196/) — original approval 2002-07-17

## JNJ — JOHNSON & JOHNSON

- [VASCOR — FDA application NDA019002](/drug/nda-019002/) — original approval 1990-12-28
- [ERYCETTE — FDA application NDA050594](/drug/nda-050594/) — original approval 1985-02-15
- [GRIFULVIN V — FDA application NDA050448](/drug/nda-050448/) — original approval 1972-05-30

## LGND — LIGAND PHARMACEUTICALS INC

- [SITAVIG — FDA application NDA203791](/drug/nda-203791/) — original approval 2013-04-12

## LLY — ELI LILLY & Co

- [FOUNDAYO — FDA application NDA220934](/drug/nda-220934/) — original approval 2026-04-01
- [INLURIYO — FDA application NDA218881](/drug/nda-218881/) — original approval 2025-09-25
- [EBGLYSS — FDA application BLA761306](/drug/bla-761306/) — original approval 2024-09-13
- [KISUNLA — FDA application BLA761248](/drug/bla-761248/) — original approval 2024-07-02
- [RETEVMO — FDA application NDA218160](/drug/nda-218160/) — original approval 2024-04-10
- [ZEPBOUND / ZEPBOUND (AUTOINJECTOR) / ZEPBOUND KWIKPEN — FDA application NDA217806](/drug/nda-217806/) — original approval 2023-11-08
- [OMVOH — FDA application BLA761279](/drug/bla-761279/) — original approval 2023-10-26
- [MOUNJARO / MOUNJARO (AUTOINJECTOR) / MOUNJARO KWIKPEN — FDA application NDA215866](/drug/nda-215866/) — original approval 2022-05-13
- [LYUMJEV — FDA application BLA761109](/drug/bla-761109/) — original approval 2020-06-15
- [RETEVMO — FDA application NDA213246](/drug/nda-213246/) — original approval 2020-05-08
- [REYVOW — FDA application NDA211280](/drug/nda-211280/) — original approval 2019-10-11
- [EMGALITY — FDA application BLA761063](/drug/bla-761063/) — original approval 2018-09-27
- [OLUMIANT — FDA application NDA207924](/drug/nda-207924/) — original approval 2018-05-31
- [VERZENIO — FDA application NDA208855](/drug/nda-208855/) — original approval 2018-02-26
- [VERZENIO — FDA application NDA208716](/drug/nda-208716/) — original approval 2017-09-28
- [LARTRUVO — FDA application BLA761038](/drug/bla-761038/) — original approval 2016-10-19
- [TALTZ — FDA application BLA125521](/drug/bla-125521/) — original approval 2016-03-22
- [BASAGLAR — FDA application BLA205692](/drug/bla-205692/) — original approval 2015-12-16
- [PORTRAZZA — FDA application BLA125547](/drug/bla-125547/) — original approval 2015-11-24
- [HUMALOG KWIKPEN — FDA application BLA205747](/drug/bla-205747/) — original approval 2015-05-26
- [TRULICITY — FDA application BLA125469](/drug/bla-125469/) — original approval 2014-09-18
- [CYRAMZA — FDA application BLA125477](/drug/bla-125477/) — original approval 2014-04-21
- [AXIRON — FDA application NDA022504](/drug/nda-022504/) — original approval 2010-11-23
- [ADCIRCA — FDA application NDA022332](/drug/nda-022332/) — original approval 2009-05-22
- [PROZAC / SARAFEM — FDA application NDA018936](/drug/nda-018936/) — original approval 1987-12-29

## LNTH — Lantheus Holdings, Inc.

- [NEURACEQ — FDA application NDA204677](/drug/nda-204677/) — original approval 2014-03-19

## MNKD — MANNKIND CORP

- [AFREZZA — FDA application BLA022472](/drug/bla-022472/) — original approval 2014-06-27

## MRK — Merck & Co., Inc.

- [EMEND — FDA application NDA022023](/drug/nda-022023/) — original approval 2008-01-25
- [VIOXX — FDA application NDA021647](/drug/nda-021647/) — original approval 2004-03-26
- [FOSAMAX — FDA application NDA021575](/drug/nda-021575/) — original approval 2003-09-17
- [CANCIDAS — FDA application NDA021227](/drug/nda-021227/) — original approval 2001-01-26
- [VIOXX — FDA application NDA021052](/drug/nda-021052/) — original approval 1999-05-20
- [VIOXX — FDA application NDA021042](/drug/nda-021042/) — original approval 1999-05-20
- [PEPCID RPD — FDA application NDA020752](/drug/nda-020752/) — original approval 1998-05-28
- [TIAMATE — FDA application NDA020506](/drug/nda-020506/) — original approval 1996-10-04
- [CHIBROXIN — FDA application NDA019757](/drug/nda-019757/) — original approval 1991-06-17
- [PRIMAXIN — FDA application NDA050630](/drug/nda-050630/) — original approval 1990-12-14
- [PRINZIDE — FDA application NDA019778](/drug/nda-019778/) — original approval 1989-02-16
- [PRINIVIL — FDA application NDA019558](/drug/nda-019558/) — original approval 1987-12-29
- [MEVACOR — FDA application NDA019643](/drug/nda-019643/) — original approval 1987-08-31
- [PRIMAXIN — FDA application ANDA062756](/drug/anda-062756/) — original approval 1987-01-08
- [PEPCID / PEPCID PRESERVATIVE FREE — FDA application NDA019510](/drug/nda-019510/) — original approval 1986-11-04
- [NOROXIN — FDA application NDA019384](/drug/nda-019384/) — original approval 1986-10-31
- [PRIMAXIN — FDA application NDA050587](/drug/nda-050587/) — original approval 1985-11-26
- [DOLOBID — FDA application NDA018445](/drug/nda-018445/) — original approval 1982-04-19
- [TIMOLIDE 10-25 — FDA application NDA018061](/drug/nda-018061/) — original approval 1981-12-11
- [BLOCADREN — FDA application NDA018017](/drug/nda-018017/) — original approval 1981-11-25
- [MODURETIC 5-50 — FDA application NDA018201](/drug/nda-018201/) — original approval 1981-10-05
- [ALDOMET — FDA application NDA018389](/drug/nda-018389/) — original approval 1981-08-28
- [CLINORIL — FDA application NDA017911](/drug/nda-017911/) — original approval 1978-09-27
- [ELSPAR — FDA application BLA101063](/drug/bla-101063/) — original approval 1978-01-10
- [ALPHAREDISOL — FDA application ANDA080778](/drug/anda-080778/) — original approval 1975-04-18
- [HYDROPRES 25 / HYDROPRES 50 — FDA application NDA011958](/drug/nda-011958/) — original approval 1974-05-16
- [DECADRON-LA — FDA application NDA016675](/drug/nda-016675/) — original approval 1973-09-06
- [NEODECADRON — FDA application NDA050324](/drug/nda-050324/) — original approval 1969-09-15
- [NEODECADRON — FDA application NDA050322](/drug/nda-050322/) — original approval 1969-07-02
- [ALDOCLOR-150 / ALDOCLOR-250 — FDA application NDA016016](/drug/nda-016016/) — original approval 1968-03-20
- [ALDORIL 15 / ALDORIL 25 / ALDORIL D30 / ALDORIL D50 — FDA application NDA013402](/drug/nda-013402/) — original approval 1962-12-20
- [ALDOMET — FDA application NDA013401](/drug/nda-013401/) — original approval 1962-12-20
- [ALDOMET — FDA application NDA013400](/drug/nda-013400/) — original approval 1962-12-20
- [DECADRON W/ XYLOCAINE — FDA application NDA013334](/drug/nda-013334/) — original approval 1962-07-11
- [PERIACTIN — FDA application NDA013220](/drug/nda-013220/) — original approval 1962-03-30
- [PERIACTIN — FDA application NDA012649](/drug/nda-012649/) — original approval 1961-10-17
- [COLBENEMID — FDA application NDA012383](/drug/nda-012383/) — original approval 1961-07-27
- [DECASPRAY — FDA application NDA012731](/drug/nda-012731/) — original approval 1961-03-29
- [DECADRON — FDA application NDA012376](/drug/nda-012376/) — original approval 1960-07-07
- [HYDROCORTONE — FDA application NDA012052](/drug/nda-012052/) — original approval 1960-06-08
- [DECADRON — FDA application NDA012071](/drug/nda-012071/) — original approval 1959-10-06
- [DECADRON — FDA application NDA011984](/drug/nda-011984/) — original approval 1959-09-02
- [DECADRON — FDA application NDA011977](/drug/nda-011977/) — original approval 1959-09-02
- [DECADRON — FDA application NDA011983](/drug/nda-011983/) — original approval 1959-08-26
- [HUMORSOL — FDA application NDA011860](/drug/nda-011860/) — original approval 1959-08-05
- [HYDRODIURIL — FDA application NDA011835](/drug/nda-011835/) — original approval 1959-02-24
- [DIUPRES-250 / DIUPRES-500 — FDA application NDA011635](/drug/nda-011635/) — original approval 1958-12-11
- [DECADRON — FDA application NDA011664](/drug/nda-011664/) — original approval 1958-10-30
- [LERITINE — FDA application NDA010585](/drug/nda-010585/) — original approval 1957-08-15
- [FLOROPRYL — FDA application NDA010656](/drug/nda-010656/) — original approval 1957-04-02
- [HYDELTRA-TBA — FDA application NDA010562](/drug/nda-010562/) — original approval 1956-07-25
- [ARAMINE — FDA application NDA009509](/drug/nda-009509/) — original approval 1954-09-29
- [COGENTIN — FDA application NDA009193](/drug/nda-009193/) — original approval 1954-03-05
- [HYDROCORTONE — FDA application NDA008506](/drug/nda-008506/) — original approval 1952-08-05
- [HYDROCORTONE — FDA application NDA008228](/drug/nda-008228/) — original approval 1951-12-21
- [BENEMID — FDA application NDA007898](/drug/nda-007898/) — original approval 1951-04-26
- [CORTONE — FDA application NDA007750](/drug/nda-007750/) — original approval 1950-12-04
- [CORTONE — FDA application NDA007110](/drug/nda-007110/) — original approval 1950-06-13
- [AMINOHIPPURATE SODIUM — FDA application NDA005619](/drug/nda-005619/) — original approval 1944-12-30

## NUVL — Nuvalent, Inc.

- [JIDEYTRO — FDA application NDA220185](/drug/nda-220185/) — original approval 2026-07-22

## OCUL — OCULAR THERAPEUTIX, INC

- [DEXTENZA — FDA application NDA208742](/drug/nda-208742/) — original approval 2018-11-30

## OGN — Organon & Co.

- [VTAMA — FDA application NDA215272](/drug/nda-215272/) — original approval 2022-05-23
- [XACIATO — FDA application NDA215650](/drug/nda-215650/) — original approval 2021-12-07
- [ASMANEX HFA — FDA application NDA205641](/drug/nda-205641/) — original approval 2014-04-25
- [LIPTRUZET — FDA application NDA200153](/drug/nda-200153/) — original approval 2013-05-03
- [DULERA — FDA application NDA022518](/drug/nda-022518/) — original approval 2010-06-22
- [IMPLANON / NEXPLANON — FDA application NDA021529](/drug/nda-021529/) — original approval 2006-07-17
- [CLARINEX-D 12 HOUR — FDA application NDA021313](/drug/nda-021313/) — original approval 2006-02-01
- [FOSAMAX PLUS D — FDA application NDA021762](/drug/nda-021762/) — original approval 2005-04-07
- [ASMANEX TWISTHALER — FDA application NDA021067](/drug/nda-021067/) — original approval 2005-03-30
- [CLARINEX D 24 HOUR — FDA application NDA021605](/drug/nda-021605/) — original approval 2005-03-03
- [CLARINEX — FDA application NDA021300](/drug/nda-021300/) — original approval 2004-09-01
- [VYTORIN — FDA application NDA021687](/drug/nda-021687/) — original approval 2004-07-23
- [ZETIA — FDA application NDA021445](/drug/nda-021445/) — original approval 2002-10-25
- [SINGULAIR — FDA application NDA021409](/drug/nda-021409/) — original approval 2002-07-26
- [CLARINEX — FDA application NDA021312](/drug/nda-021312/) — original approval 2002-06-26
- [CLARINEX — FDA application NDA021165](/drug/nda-021165/) — original approval 2001-12-21
- [MAXALT-MLT — FDA application NDA020865](/drug/nda-020865/) — original approval 1998-06-29
- [MAXALT — FDA application NDA020864](/drug/nda-020864/) — original approval 1998-06-29
- [SINGULAIR — FDA application NDA020830](/drug/nda-020830/) — original approval 1998-02-20
- [SINGULAIR — FDA application NDA020829](/drug/nda-020829/) — original approval 1998-02-20
- [PROPECIA — FDA application NDA020788](/drug/nda-020788/) — original approval 1997-12-19
- [NASONEX — FDA application NDA020762](/drug/nda-020762/) — original approval 1997-10-01
- [REMERON — FDA application NDA020415](/drug/nda-020415/) — original approval 1996-06-14
- [FOSAMAX — FDA application NDA020560](/drug/nda-020560/) — original approval 1995-09-29
- [HYZAAR — FDA application NDA020387](/drug/nda-020387/) — original approval 1995-04-28
- [COZAAR — FDA application NDA020386](/drug/nda-020386/) — original approval 1995-04-14
- [PROSCAR — FDA application NDA020180](/drug/nda-020180/) — original approval 1992-06-19
- [ZOCOR — FDA application NDA019766](/drug/nda-019766/) — original approval 1991-12-23
- [SINEMET CR — FDA application NDA019856](/drug/nda-019856/) — original approval 1991-05-30
- [ELOCON — FDA application NDA019796](/drug/nda-019796/) — original approval 1989-03-30
- [DIPROLENE — FDA application NDA019716](/drug/nda-019716/) — original approval 1988-08-01
- [ELOCON — FDA application NDA019625](/drug/nda-019625/) — original approval 1987-05-06
- [ELOCON — FDA application NDA019543](/drug/nda-019543/) — original approval 1987-04-30
- [DIPROLENE AF — FDA application NDA019555](/drug/nda-019555/) — original approval 1987-04-27
- [LOTRISONE — FDA application NDA018827](/drug/nda-018827/) — original approval 1984-07-10
- [DIPROLENE — FDA application NDA018741](/drug/nda-018741/) — original approval 1983-07-27
- [SINEMET — FDA application NDA017555](/drug/nda-017555/) — original approval 1975-05-02
- [CELESTONE SOLUSPAN — FDA application NDA014602](/drug/nda-014602/) — original approval 1965-03-03

## OMER — OMEROS CORP

- [YARTEMLEA — FDA application BLA761152](/drug/bla-761152/) — original approval 2025-12-23

## PFE — PFIZER INC

- [HYMPAVZI — FDA application BLA761369](/drug/bla-761369/) — original approval 2024-10-11
- [TALZENNA — FDA application NDA217439](/drug/nda-217439/) — original approval 2024-03-07
- [VELSIPITY — FDA application NDA216956](/drug/nda-216956/) — original approval 2023-10-12
- [ELREXFIO — FDA application BLA761345](/drug/bla-761345/) — original approval 2023-08-14
- [LITFULO — FDA application NDA215830](/drug/nda-215830/) — original approval 2023-06-23
- [PAXLOVID (COPACKAGED) — FDA application NDA217188](/drug/nda-217188/) — original approval 2023-05-25
- [ZAVZPRET — FDA application NDA216386](/drug/nda-216386/) — original approval 2023-03-09
- [CIBINQO — FDA application NDA213871](/drug/nda-213871/) — original approval 2022-01-14
- [XELJANZ — FDA application NDA213082](/drug/nda-213082/) — original approval 2020-09-25
- [NURTEC ODT — FDA application NDA212728](/drug/nda-212728/) — original approval 2020-02-27
- [ABRILADA — FDA application BLA761118](/drug/bla-761118/) — original approval 2019-11-15
- [IBRANCE — FDA application NDA212436](/drug/nda-212436/) — original approval 2019-11-01
- [RUXIENCE — FDA application BLA761103](/drug/bla-761103/) — original approval 2019-07-23
- [ZIRABEV — FDA application BLA761099](/drug/bla-761099/) — original approval 2019-06-27
- [TRAZIMERA — FDA application BLA761081](/drug/bla-761081/) — original approval 2019-03-11
- [DAURISMO — FDA application NDA210656](/drug/nda-210656/) — original approval 2018-11-21
- [LORBRENA — FDA application NDA210868](/drug/nda-210868/) — original approval 2018-11-02
- [TALZENNA — FDA application NDA211651](/drug/nda-211651/) — original approval 2018-10-16
- [VIZIMPRO — FDA application NDA211288](/drug/nda-211288/) — original approval 2018-09-27
- [IXIFI — FDA application BLA761072](/drug/bla-761072/) — original approval 2017-12-13
- [TROXYCA ER — FDA application NDA207621](/drug/nda-207621/) — original approval 2016-08-19
- [XELJANZ XR — FDA application NDA208246](/drug/nda-208246/) — original approval 2016-02-23
- [IBRANCE — FDA application NDA207103](/drug/nda-207103/) — original approval 2015-02-03
- [ELELYSO — FDA application BLA022458](/drug/bla-022458/) — original approval 2012-05-01
- [HEPARIN SODIUM / HEPARIN SODIUM PRESERVATIVE FREE — FDA application NDA201370](/drug/nda-201370/) — original approval 2011-07-21
- [TOVIAZ — FDA application NDA022030](/drug/nda-022030/) — original approval 2008-10-31
- [GEODON — FDA application NDA021483](/drug/nda-021483/) — original approval 2006-03-29
- [ERAXIS — FDA application NDA021948](/drug/nda-021948/) — original approval 2006-02-17
- [DEPO-SUBQ PROVERA 104 — FDA application NDA021583](/drug/nda-021583/) — original approval 2004-12-17
- [VFEND — FDA application NDA021466](/drug/nda-021466/) — original approval 2003-11-14
- [VFEND — FDA application NDA021464](/drug/nda-021464/) — original approval 2003-11-14
- [DAYPRO ALTA — FDA application NDA020776](/drug/nda-020776/) — original approval 2002-10-17
- [CAVERJECT IMPULSE — FDA application NDA021212](/drug/nda-021212/) — original approval 2002-06-11
- [ZITHROMAX — FDA application NDA050784](/drug/nda-050784/) — original approval 2002-05-24
- [ZYVOX — FDA application NDA021132](/drug/nda-021132/) — original approval 2000-04-18
- [ZYVOX — FDA application NDA021131](/drug/nda-021131/) — original approval 2000-04-18
- [ZYVOX — FDA application NDA021130](/drug/nda-021130/) — original approval 2000-04-18
- [AROMASIN — FDA application NDA020753](/drug/nda-020753/) — original approval 1999-10-21
- [TIKOSYN — FDA application NDA020931](/drug/nda-020931/) — original approval 1999-10-01
- [ELLENCE — FDA application NDA050778](/drug/nda-050778/) — original approval 1999-09-15
- [CLEOCIN — FDA application NDA050767](/drug/nda-050767/) — original approval 1999-08-13
- [SONATA — FDA application NDA020859](/drug/nda-020859/) — original approval 1999-08-13
- [TROVAN/ZITHROMAX COMPLIANCE PAK — FDA application NDA050762](/drug/nda-050762/) — original approval 1998-12-18
- [STERANE — FDA application NDA011446](/drug/nda-011446/) — original approval 1998-05-12
- [ARTHROTEC — FDA application NDA020607](/drug/nda-020607/) — original approval 1997-12-24
- [TROVAN PRESERVATIVE FREE — FDA application NDA020760](/drug/nda-020760/) — original approval 1997-12-18
- [TROVAN — FDA application NDA020759](/drug/nda-020759/) — original approval 1997-12-18
- [FLAGYL ER — FDA application NDA020868](/drug/nda-020868/) — original approval 1997-11-26
- [CAVERJECT — FDA application NDA020755](/drug/nda-020755/) — original approval 1997-10-31
- [NICOTROL — FDA application NDA020714](/drug/nda-020714/) — original approval 1997-05-02
- [IDAMYCIN PFS / IDARUBICIN HYDROCHLORIDE — FDA application NDA050734](/drug/nda-050734/) — original approval 1997-02-17
- [ZITHROMAX — FDA application NDA050733](/drug/nda-050733/) — original approval 1997-01-30
- [DOSTINEX — FDA application NDA020664](/drug/nda-020664/) — original approval 1996-12-23
- [GLYSET — FDA application NDA020682](/drug/nda-020682/) — original approval 1996-12-18
- [ZITHROMAX — FDA application NDA050711](/drug/nda-050711/) — original approval 1996-07-18
- [MERREM IV — FDA application NDA050706](/drug/nda-050706/) — original approval 1996-06-21
- [CAMPTOSAR — FDA application NDA020571](/drug/nda-020571/) — original approval 1996-06-14
- [ZITHROMAX — FDA application NDA050730](/drug/nda-050730/) — original approval 1996-06-12
- [ESTRING — FDA application NDA020472](/drug/nda-020472/) — original approval 1996-04-26
- [NICOTROL — FDA application NDA020385](/drug/nda-020385/) — original approval 1996-03-22
- [COVERA-HS — FDA application NDA020552](/drug/nda-020552/) — original approval 1996-02-26
- [CORVERT — FDA application NDA020491](/drug/nda-020491/) — original approval 1995-12-28
- [ZITHROMAX — FDA application NDA050710](/drug/nda-050710/) — original approval 1995-10-19
- [CAVERJECT — FDA application NDA020379](/drug/nda-020379/) — original approval 1995-07-06
- [ZINECARD — FDA application NDA020212](/drug/nda-020212/) — original approval 1995-05-26
- [FLAGYL — FDA application NDA020334](/drug/nda-020334/) — original approval 1995-05-03
- [CEFOBID — FDA application ANDA063333](/drug/anda-063333/) — original approval 1995-03-31
- [FRAGMIN — FDA application NDA020287](/drug/nda-020287/) — original approval 1994-12-22
- [ZITHROMAX — FDA application NDA050693](/drug/nda-050693/) — original approval 1994-09-28
- [COLESTID — FDA application NDA020222](/drug/nda-020222/) — original approval 1994-07-19
- [GLUCOTROL XL — FDA application NDA020329](/drug/nda-020329/) — original approval 1994-04-26
- [DIFLUCAN — FDA application NDA020090](/drug/nda-020090/) — original approval 1993-12-23
- [MYCOBUTIN — FDA application NDA050689](/drug/nda-050689/) — original approval 1992-12-23
- [PREPIDIL — FDA application NDA019617](/drug/nda-019617/) — original approval 1992-12-09
- [DEPO-PROVERA — FDA application NDA020246](/drug/nda-020246/) — original approval 1992-10-29
- [DAYPRO — FDA application NDA018841](/drug/nda-018841/) — original approval 1992-10-29
- [CLEOCIN — FDA application NDA050680](/drug/nda-050680/) — original approval 1992-08-11
- [VANTIN — FDA application NDA050675](/drug/nda-050675/) — original approval 1992-08-07
- [VANTIN — FDA application NDA050674](/drug/nda-050674/) — original approval 1992-08-07
- [GLYNASE — FDA application NDA020051](/drug/nda-020051/) — original approval 1992-03-04
- [MINIPRESS XL — FDA application NDA019775](/drug/nda-019775/) — original approval 1992-01-29
- [ZITHROMAX — FDA application NDA050670](/drug/nda-050670/) — original approval 1991-11-01
- [ADRIAMYCIN PFS — FDA application ANDA063165](/drug/anda-063165/) — original approval 1991-01-30
- [IDAMYCIN — FDA application NDA050661](/drug/nda-050661/) — original approval 1990-09-27
- [SYNAREL — FDA application NDA019886](/drug/nda-019886/) — 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](/drug/nda-019950/) — original approval 1990-01-29
- [DIFLUCAN — FDA application NDA019949](/drug/nda-019949/) — original approval 1990-01-29
- [PROCARDIA XL — FDA application NDA019684](/drug/nda-019684/) — original approval 1989-09-06
- [CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER — FDA application NDA050639](/drug/nda-050639/) — original approval 1989-08-30
- [CLEOCIN T — FDA application NDA050600](/drug/nda-050600/) — original approval 1989-05-31
- [CYTOTEC — FDA application NDA019268](/drug/nda-019268/) — original approval 1988-12-27
- [UNASYN — FDA application ANDA062901](/drug/anda-062901/) — original approval 1988-11-25
- [DOXORUBICIN HYDROCHLORIDE — FDA application NDA050629](/drug/nda-050629/) — original approval 1987-12-23
- [CLEOCIN PHOSPHATE — FDA application ANDA062803](/drug/anda-062803/) — original approval 1987-10-16
- [CLEOCIN T — FDA application NDA050615](/drug/nda-050615/) — original approval 1987-01-07
- [UNASYN — FDA application NDA050608](/drug/nda-050608/) — original approval 1986-12-31
- [CYKLOKAPRON — FDA application NDA019281](/drug/nda-019281/) — original approval 1986-12-30
- [CALAN SR — FDA application NDA019152](/drug/nda-019152/) — original approval 1986-12-16
- [CEFOBID IN PLASTIC CONTAINER — FDA application NDA050613](/drug/nda-050613/) — original approval 1986-07-23
- [NORQUEST FE — FDA application NDA018926](/drug/nda-018926/) — original approval 1986-07-18
- [CLEOCIN — FDA application ANDA062644](/drug/anda-062644/) — original approval 1986-04-07
- [PSORCON — FDA application NDA019260](/drug/nda-019260/) — original approval 1985-08-28
- [FLORONE E — FDA application NDA019259](/drug/nda-019259/) — original approval 1985-08-28
- [CALAN — FDA application NDA018817](/drug/nda-018817/) — original approval 1984-09-10
- [GLUCOTROL — FDA application NDA017783](/drug/nda-017783/) — original approval 1984-05-08
- [MICRONASE — FDA application NDA017498](/drug/nda-017498/) — original approval 1984-05-01
- [TZ-3 — FDA application NDA018682](/drug/nda-018682/) — original approval 1983-02-18
- [CEFOBID — FDA application NDA050551](/drug/nda-050551/) — original approval 1982-11-18
- [HALCION — FDA application NDA017892](/drug/nda-017892/) — original approval 1982-11-15
- [NORPACE CR — FDA application NDA018655](/drug/nda-018655/) — original approval 1982-07-20
- [FELDENE — FDA application NDA018147](/drug/nda-018147/) — original approval 1982-04-06
- [SPECTROBID — FDA application NDA050556](/drug/nda-050556/) — original approval 1982-03-23
- [PROCARDIA — FDA application NDA018482](/drug/nda-018482/) — original approval 1981-12-31
- [PROSTIN VR PEDIATRIC — FDA application NDA018484](/drug/nda-018484/) — original approval 1981-10-16
- [SPECTROBID — FDA application NDA050520](/drug/nda-050520/) — original approval 1980-12-22
- [FLAGYL I.V. / FLAGYL I.V. RTU IN PLASTIC CONTAINER — FDA application NDA018353](/drug/nda-018353/) — original approval 1980-11-28
- [VANSIL — FDA application NDA018069](/drug/nda-018069/) — original approval 1980-07-23
- [CLEOCIN / CLEOCIN T — FDA application NDA050537](/drug/nda-050537/) — original approval 1980-07-09
- [MINIZIDE — FDA application NDA017986](/drug/nda-017986/) — original approval 1980-06-13
- [VIBRA-TABS — FDA application NDA050533](/drug/nda-050533/) — original approval 1980-01-15
- [LONITEN — FDA application NDA018154](/drug/nda-018154/) — original approval 1979-10-18
- [DEPO-ESTRADIOL — FDA application ANDA085470](/drug/anda-085470/) — original approval 1979-08-15
- [DEPO-TESTOSTERONE — FDA application ANDA085635](/drug/anda-085635/) — original approval 1979-07-25
- [HEMABATE — FDA application NDA017989](/drug/nda-017989/) — original approval 1979-01-09
- [PSORCON E — FDA application NDA017994](/drug/nda-017994/) — original approval 1978-03-01
- [PFIZERPEN-A — FDA application ANDA062049](/drug/anda-062049/) — original approval 1977-12-02
- [FLORONE — FDA application NDA017741](/drug/nda-017741/) — original approval 1977-09-14
- [NORPACE — FDA application NDA017447](/drug/nda-017447/) — original approval 1977-09-01
- [PROSTIN E2 — FDA application NDA017810](/drug/nda-017810/) — original approval 1977-08-23
- [PFIZERPEN-A — FDA application ANDA062050](/drug/anda-062050/) — original approval 1977-07-05
- [OGEN .625 / OGEN 1.25 / OGEN 2.5 / OGEN 5 — FDA application ANDA083220](/drug/anda-083220/) — original approval 1977-05-19
- [COLESTID / FLAVORED COLESTID — FDA application NDA017563](/drug/nda-017563/) — original approval 1977-04-04
- [MINIPRESS — FDA application NDA017442](/drug/nda-017442/) — original approval 1976-06-23
- [PFIZERPEN VK — FDA application ANDA061815](/drug/anda-061815/) — original approval 1974-11-14
- [VIBRAMYCIN — FDA application NDA050480](/drug/nda-050480/) — original approval 1974-09-23
- [PFIZERPEN VK — FDA application ANDA061836](/drug/anda-061836/) — original approval 1974-08-09
- [DOXORUBICIN HYDROCHLORIDE — FDA application NDA050467](/drug/nda-050467/) — original approval 1974-08-07
- [EMETE-CON — FDA application NDA016820](/drug/nda-016820/) — original approval 1974-03-12
- [SINEQUAN — FDA application NDA017516](/drug/nda-017516/) — original approval 1974-03-11
- [GEOCILLIN — FDA application NDA050435](/drug/nda-050435/) — original approval 1972-10-26
- [CLEOCIN PHOSPHATE — FDA application NDA050441](/drug/nda-050441/) — original approval 1972-10-02
- [VIBRAMYCIN — FDA application NDA050442](/drug/nda-050442/) — original approval 1972-09-05
- [NAVANE — FDA application NDA016904](/drug/nda-016904/) — original approval 1971-08-19
- [TROBICIN — FDA application NDA050347](/drug/nda-050347/) — original approval 1971-06-30
- [MITHRACIN — FDA application NDA050109](/drug/nda-050109/) — original approval 1970-05-05
- [LITHIUM CARBONATE — FDA application NDA016834](/drug/nda-016834/) — original approval 1970-04-06
- [NAVANE — FDA application NDA016758](/drug/nda-016758/) — original approval 1970-04-06
- [CLEOCIN HYDROCHLORIDE — FDA application NDA050162](/drug/nda-050162/) — original approval 1970-02-22
- [SINEQUAN — FDA application NDA016798](/drug/nda-016798/) — original approval 1969-09-23
- [TERRA-CORTRIL — FDA application ANDA061016](/drug/anda-061016/) — original approval 1969-09-18
- [TAO — FDA application NDA050336](/drug/nda-050336/) — original approval 1969-05-27
- [VISTARIL — FDA application NDA011459](/drug/nda-011459/) — original approval 1968-11-15
- [PFIZERPEN — FDA application ANDA060657](/drug/anda-060657/) — original approval 1968-08-30
- [VIBRAMYCIN — FDA application NDA050006](/drug/nda-050006/) — original approval 1967-12-06
- [VIBRAMYCIN — FDA application NDA050007](/drug/nda-050007/) — original approval 1967-12-05
- [NAVANE — FDA application NDA016584](/drug/nda-016584/) — original approval 1967-07-24
- [LINCOCIN — FDA application NDA050317](/drug/nda-050317/) — original approval 1964-12-29
- [TERRAMYCIN — FDA application ANDA060567](/drug/anda-060567/) — original approval 1964-09-15
- [TERRAMYCIN — FDA application NDA050286](/drug/nda-050286/) — original approval 1964-09-08
- [RENESE-R — FDA application NDA013636](/drug/nda-013636/) — original approval 1963-10-15
- [FLAGYL — FDA application NDA012623](/drug/nda-012623/) — original approval 1963-07-18
- [RENESE — FDA application NDA012845](/drug/nda-012845/) — original approval 1961-09-26
- [ALDACTAZIDE — FDA application NDA012616](/drug/nda-012616/) — original approval 1961-01-27
- [DIDREX — FDA application NDA012427](/drug/nda-012427/) — original approval 1960-10-26
- [DEPO-PROVERA — FDA application NDA012541](/drug/nda-012541/) — original approval 1960-09-23
- [LOMOTIL — FDA application NDA012462](/drug/nda-012462/) — original approval 1960-09-15
- [ALDACTONE — FDA application NDA012151](/drug/nda-012151/) — original approval 1960-01-21
- [PROVERA — FDA application NDA011839](/drug/nda-011839/) — original approval 1959-06-18
- [VISTARIL — FDA application NDA011795](/drug/nda-011795/) — original approval 1959-06-03
- [DEPO-MEDROL — FDA application NDA011757](/drug/nda-011757/) — original approval 1959-05-27
- [DIABINESE — FDA application NDA011641](/drug/nda-011641/) — original approval 1958-10-28
- [TESSALON — FDA application NDA011210](/drug/nda-011210/) — original approval 1958-02-10
- [MEDROL — FDA application NDA011153](/drug/nda-011153/) — original approval 1957-10-24
- [VISTARIL — FDA application NDA011111](/drug/nda-011111/) — original approval 1957-09-18
- [MODERIL — FDA application NDA010686](/drug/nda-010686/) — original approval 1956-10-31
- [MAGNACORT — FDA application NDA010554](/drug/nda-010554/) — original approval 1956-10-15
- [ATARAX — FDA application NDA010392](/drug/nda-010392/) — original approval 1956-04-12
- [STERANE — FDA application NDA009996](/drug/nda-009996/) — original approval 1955-07-01
- [TETRACYN — FDA application ANDA060285](/drug/anda-060285/) — original approval 1954-01-04
- [CORTRIL — FDA application NDA009127](/drug/nda-009127/) — original approval 1953-12-03
- [STREPTOMYCIN SULFATE — FDA application ANDA060111](/drug/anda-060111/) — original approval 1952-02-12
- [PFIZERPEN G — FDA application ANDA060587](/drug/anda-060587/) — original approval 1951-09-13
- [PFIZERPEN-AS — FDA application ANDA060286](/drug/anda-060286/) — original approval 1950-11-01
- [AZULFIDINE / AZULFIDINE EN-TABS — FDA application NDA007073](/drug/nda-007073/) — original approval 1950-06-20
- [PENICILLIN G PROCAINE — FDA application ANDA060099](/drug/anda-060099/) — original approval 1948-11-10
- [PFIZERPEN G — FDA application ANDA060075](/drug/anda-060075/) — original approval 1948-03-02
- [PENICILLIN G POTASSIUM — FDA application ANDA060074](/drug/anda-060074/) — original approval 1947-02-06
- [STREPTOMYCIN SULFATE — FDA application ANDA060076](/drug/anda-060076/) — original approval 1946-02-18

## PHAT — Phathom Pharmaceuticals, Inc.

- [VOQUEZNA — FDA application NDA218710](/drug/nda-218710/) — original approval 2024-07-17

## PRGO — PERRIGO Co plc

- [DESLORATADINE — FDA application ANDA078361](/drug/anda-078361/) — original approval 2011-12-22
- [FAMOTIDINE — FDA application ANDA075400](/drug/anda-075400/) — original approval 2005-03-18
- [LORATADINE — FDA application ANDA075728](/drug/anda-075728/) — original approval 2004-08-20
- [LORATADINE — FDA application ANDA076301](/drug/anda-076301/) — original approval 2004-06-25
- [LORATADINE — FDA application NDA021512](/drug/nda-021512/) — original approval 2004-06-24
- [MICONAZOLE 3 COMBINATION PACK — FDA application ANDA076357](/drug/anda-076357/) — original approval 2004-03-30
- [NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE — FDA application ANDA076518](/drug/anda-076518/) — original approval 2004-03-17
- [IBUPROFEN — FDA application ANDA076359](/drug/anda-076359/) — original approval 2004-01-16
- [IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE — FDA application ANDA076478](/drug/anda-076478/) — original approval 2003-11-05
- [FAMOTIDINE — FDA application ANDA075715](/drug/anda-075715/) — original approval 2003-08-22
- [RANITIDINE HYDROCHLORIDE — FDA application ANDA076195](/drug/anda-076195/) — original approval 2002-08-30
- [LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE — FDA application ANDA076029](/drug/anda-076029/) — original approval 2002-08-30
- [IBUPROFEN — FDA application ANDA075995](/drug/anda-075995/) — original approval 2002-03-14
- [KETOPROFEN — FDA application ANDA075364](/drug/anda-075364/) — original approval 2002-02-07
- [CROMOLYN SODIUM — FDA application ANDA075427](/drug/anda-075427/) — original approval 2001-12-12
- [ACETAMINOPHEN, ASPIRIN AND CAFFEINE — FDA application ANDA075794](/drug/anda-075794/) — original approval 2001-11-26
- [TIOCONAZOLE — FDA application ANDA075915](/drug/anda-075915/) — original approval 2001-11-21
- [MINOXIDIL EXTRA STRENGTH (FOR MEN) — FDA application ANDA075598](/drug/anda-075598/) — original approval 2001-06-13
- [ACETAMINOPHEN — FDA application ANDA075077](/drug/anda-075077/) — original approval 2000-02-25
- [CHILDREN'S IBUPROFEN — FDA application ANDA074937](/drug/anda-074937/) — original approval 1998-12-22
- [CIMETIDINE — FDA application ANDA074972](/drug/anda-074972/) — original approval 1998-06-19
- [MICONAZOLE NITRATE — FDA application ANDA074760](/drug/anda-074760/) — original approval 1997-05-15
- [MICONAZOLE NITRATE — FDA application ANDA074395](/drug/anda-074395/) — original approval 1997-03-20
- [NAPROXEN SODIUM — FDA application ANDA074661](/drug/anda-074661/) — original approval 1997-01-13
- [CLINDETS — FDA application ANDA064136](/drug/anda-064136/) — original approval 1996-09-30
- [DOXYLAMINE SUCCINATE — FDA application ANDA040167](/drug/anda-040167/) — original approval 1996-09-18
- [LOPERAMIDE HYDROCHLORIDE — FDA application ANDA074194](/drug/anda-074194/) — original approval 1992-10-30
- [LOPERAMIDE HYDROCHLORIDE — FDA application ANDA073243](/drug/anda-073243/) — original approval 1992-01-21
- [IBUPROFEN — FDA application ANDA072098](/drug/anda-072098/) — original approval 1987-12-08
- [CAP-PROFEN — FDA application ANDA072097](/drug/anda-072097/) — original approval 1987-12-08
- [IBUPROFEN — FDA application ANDA072096](/drug/anda-072096/) — original approval 1987-12-08
- [TAB-PROFEN — FDA application ANDA072095](/drug/anda-072095/) — original approval 1987-12-08

## REGN — REGENERON PHARMACEUTICALS, INC.

- [EYLEA HD — FDA application BLA761355](/drug/bla-761355/) — original approval 2023-08-18
- [VEOPOZ — FDA application BLA761339](/drug/bla-761339/) — original approval 2023-08-18
- [EVKEEZA — FDA application BLA761181](/drug/bla-761181/) — original approval 2021-02-11
- [INMAZEB — FDA application BLA761169](/drug/bla-761169/) — original approval 2020-10-14
- [LIBTAYO — FDA application BLA761097](/drug/bla-761097/) — original approval 2018-09-28
- [DUPIXENT — FDA application BLA761055](/drug/bla-761055/) — original approval 2017-03-28
- [PRALUENT — FDA application BLA125559](/drug/bla-125559/) — original approval 2015-07-24
- [EYLEA — FDA application BLA125387](/drug/bla-125387/) — original approval 2011-11-18

## RIGL — RIGEL PHARMACEUTICALS INC

- [VEPPANU — FDA application NDA219835](/drug/nda-219835/) — original approval 2026-05-01
- [REZLIDHIA — FDA application NDA215814](/drug/nda-215814/) — original approval 2022-12-01
- [GAVRETO — FDA application NDA213721](/drug/nda-213721/) — original approval 2020-09-04
- [TAVALISSE — FDA application NDA209299](/drug/nda-209299/) — original approval 2018-04-17

## SIGA — SIGA TECHNOLOGIES INC

- [TPOXX — FDA application NDA214518](/drug/nda-214518/) — original approval 2022-05-18
- [TPOXX — FDA application NDA208627](/drug/nda-208627/) — original approval 2018-07-13

## SUPN — SUPERNUS PHARMACEUTICALS, INC.

- [QELBREE — FDA application NDA211964](/drug/nda-211964/) — original approval 2021-04-02
- [OSMOLEX ER — FDA application NDA209410](/drug/nda-209410/) — original approval 2018-02-16
- [GOCOVRI — FDA application NDA208944](/drug/nda-208944/) — original approval 2017-08-24
- [TROKENDI XR — FDA application NDA201635](/drug/nda-201635/) — original approval 2013-08-16
- [OXTELLAR XR — FDA application NDA202810](/drug/nda-202810/) — original approval 2012-10-19

## TGTX — TG THERAPEUTICS, INC.

- [BRIUMVI — FDA application BLA761238](/drug/bla-761238/) — original approval 2022-12-28

## URGN — UroGen Pharma Ltd.

- [ZUSDURI — FDA application NDA215793](/drug/nda-215793/) — original approval 2025-06-12
- [JELMYTO — FDA application NDA211728](/drug/nda-211728/) — original approval 2020-04-15

## VERA — Vera Therapeutics, Inc.

- [TRUTAKNA — FDA application BLA761486](/drug/bla-761486/) — original approval 2026-07-07

## VNDA — Vanda Pharmaceuticals Inc.

- [BYSANTI — FDA application NDA220358](/drug/nda-220358/) — original approval 2026-02-20
- [NEREUS — FDA application NDA220152](/drug/nda-220152/) — original approval 2025-12-30
- [PONVORY — FDA application NDA213498](/drug/nda-213498/) — original approval 2021-03-18
- [HETLIOZ LQ — FDA application NDA214517](/drug/nda-214517/) — original approval 2020-12-01
- [HETLIOZ — FDA application NDA205677](/drug/nda-205677/) — original approval 2014-01-31
- [FANAPT — FDA application NDA022192](/drug/nda-022192/) — original approval 2009-05-06

## VSTM — Verastem, Inc.

- [AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) — FDA application NDA219616](/drug/nda-219616/) — original approval 2025-05-08

## VTRS — Viatris Inc

- [TOBI PODHALER — FDA application NDA201688](/drug/nda-201688/) — original approval 2013-03-22
- [REVATIO — FDA application NDA203109](/drug/nda-203109/) — original approval 2012-08-30
- [REVATIO — FDA application NDA022473](/drug/nda-022473/) — original approval 2009-11-18
- [EDLUAR — FDA application NDA021997](/drug/nda-021997/) — original approval 2009-03-13
- [ASTEPRO — FDA application NDA022203](/drug/nda-022203/) — original approval 2008-10-15
- [ELESTRIN — FDA application NDA021813](/drug/nda-021813/) — original approval 2006-12-15
- [REVATIO — FDA application NDA021845](/drug/nda-021845/) — original approval 2005-06-03
- [CARDURA XL — FDA application NDA021269](/drug/nda-021269/) — original approval 2005-02-22
- [GEODON — FDA application NDA020919](/drug/nda-020919/) — original approval 2002-06-21
- [GEODON — FDA application NDA020825](/drug/nda-020825/) — original approval 2001-02-05
- [NITROSTAT — FDA application NDA021134](/drug/nda-021134/) — original approval 2000-05-01
- [NEURONTIN — FDA application NDA021129](/drug/nda-021129/) — original approval 2000-03-02
- [ZOLOFT — FDA application NDA020990](/drug/nda-020990/) — original approval 1999-12-07
- [NEURONTIN — FDA application NDA020882](/drug/nda-020882/) — original approval 1998-10-09
- [VIAGRA — FDA application NDA020895](/drug/nda-020895/) — original approval 1998-03-27
- [TOBI — FDA application NDA050753](/drug/nda-050753/) — original approval 1997-12-22
- [MUSE — FDA application NDA020700](/drug/nda-020700/) — original approval 1996-11-19
- [NEURONTIN — FDA application NDA020235](/drug/nda-020235/) — original approval 1993-12-30
- [NORVASC — FDA application NDA019787](/drug/nda-019787/) — original approval 1992-07-31
- [ZOLOFT — FDA application NDA019839](/drug/nda-019839/) — original approval 1991-12-30
- [CARDURA — FDA application NDA019668](/drug/nda-019668/) — original approval 1990-11-02
- [EPI E Z PEN JR / EPIPEN / EPIPEN E Z PEN / EPIPEN JR. — FDA application NDA019430](/drug/nda-019430/) — original approval 1987-12-22
- [CORTIFOAM — FDA application NDA017351](/drug/nda-017351/) — original approval 1982-02-12
- [DILANTIN — FDA application ANDA084349](/drug/anda-084349/) — original approval 1976-08-27
- [DILANTIN-125 / DILANTIN-30 — FDA application NDA008762](/drug/nda-008762/) — original approval 1953-01-06