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FDA Orange Book · active-ingredient family

Famotidine

Famotidine is approved as 10 brand and 90 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FAMOTIDINE · NDA 219935

10

Brand (NDA)

90

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · for suspension, injectable, solution, tablet, tablet, chewable, tablet, orally disintegrating

ProductApplicantApplicationTEApproved
FAMOTIDINERLD×3SAGENTNDA 219935—Jul 16, 2025
PEPCID ACRLD×2KENVUE BRANDSNDA 020801—Sep 24, 1998
PEPCID ACRLD×2KENVUE BRANDSNDA 020325—Apr 28, 1995
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINERRLDMERCK SHARP DOHMENDA 020249—Feb 18, 1994
PEPCIDRLDSALIX PHARMSNDA 019527—Feb 02, 1987
PEPCIDRLD×2MERCKNDA 019510—Nov 04, 1986
PEPCIDRLD×2BAUSCHNDA 019462—Oct 15, 1986
FLUXID×2UCB INCNDA 021712—Sep 24, 2004
PEPCID ACJ AND J CONSUMER INCNDA 020902—Aug 05, 1999
PEPCID RPD×2MERCKNDA 020752—May 28, 1998

Generic (ANDA) products (90)

ProductApplicantApplicationTEApproved
FAMOTIDINELUPINANDA 217432APMay 12, 2026
FAMOTIDINECONTRACT PHARMACALANDA 219603ABMar 09, 2026
FAMOTIDINEMSNANDA 219863ABJul 24, 2025
FAMOTIDINEAUROBINDO PHARMA LTDANDA 219091ABJul 09, 2025
FAMOTIDINEBIONPHARMAANDA 219153—Jun 23, 2025
FAMOTIDINELANNETT CO INCANDA 217982ABJun 02, 2025
FAMOTIDINE×2REGCON HOLDINGSANDA 218631ABMar 25, 2025
FAMOTIDINEEPIC PHARMA LLCANDA 218344ABOct 16, 2024
FAMOTIDINE×2MSNANDA 217400ABAug 06, 2024
FAMOTIDINE×2CONTRACT PHARMACALANDA 218003—May 28, 2024
FAMOTIDINE×2GRAVITI PHARMSANDA 218461—Mar 14, 2024
FAMOTIDINEUNICHEMANDA 217605ABJan 16, 2024
FAMOTIDINE×2RISINGANDA 218181ABDec 22, 2023
FAMOTIDINE×2CONTRACT PHARMACALANDA 217669ABDec 20, 2023
FAMOTIDINEAJANTA PHARMA LTDANDA 217529ABSep 18, 2023
FAMOTIDINEMICRO LABSANDA 217842ABSep 14, 2023
FAMOTIDINEANNORA PHARMAANDA 217330ABAug 17, 2023
FAMOTIDINECARNEGIEANDA 217137ABJul 07, 2023
FAMOTIDINESOMERSET THERAPS LLCANDA 217655ABJun 16, 2023
FAMOTIDINEALKEM LABS LTDANDA 216400ABMay 15, 2023
FAMOTIDINE×2ALKEM LABS LTDANDA 217375ABApr 24, 2023
FAMOTIDINE×2MARKSANS PHARMAANDA 217543—Mar 08, 2023
FAMOTIDINEZYDUS PHARMSANDA 215828—Nov 22, 2022
FAMOTIDINEAMNEALANDA 216427ABAug 04, 2022
FAMOTIDINE×2ZYDUS PHARMSANDA 216441ABJun 03, 2022
FAMOTIDINE×2VKT PHARMAANDA 215822—Jan 28, 2022
FAMOTIDINE×2VKT PHARMAANDA 215630ABJan 07, 2022
FAMOTIDINE×2ANNORA PHARMAANDA 215766—Nov 08, 2021
FAMOTIDINE×2ANNORA PHARMAANDA 215767ABNov 04, 2021
FAMOTIDINE×2ASCENT PHARMS INCANDA 216030—Nov 03, 2021
FAMOTIDINE×2ASCENT PHARMS INCANDA 215689ABOct 15, 2021
FAMOTIDINENOVITIUM PHARMAANDA 215043ABApr 20, 2021
FAMOTIDINE×2AUROBINDO PHARMAANDA 206531—Apr 26, 2016
FAMOTIDINE×2AUROBINDO PHARMA LTDANDA 206530ABDec 22, 2015
FAMOTIDINENOVITIUM PHARMAANDA 201995ABMay 30, 2014
FAMOTIDINENOVEL LABS INCANDA 201695ABDec 17, 2012
FAMOTIDINEGLENMARK PHARMSANDA 090837—Aug 04, 2010
FAMOTIDINELUPIN LTDANDA 090440ABJun 29, 2010
FAMOTIDINENAVINTA LLCANDA 091020ABMay 27, 2010
FAMOTIDINE×2SUN PHARM INDS LTDANDA 090283—Nov 17, 2009
FAMOTIDINE×2ALEMBIC PHARMS LTDANDA 078916ABMay 22, 2009
FAMOTIDINEMYLAN LABS LTDANDA 078641APJun 25, 2008
FAMOTIDINE PRESERVATIVE FREEMYLAN LABS LTDANDA 078642APJun 25, 2008
FAMOTIDINEPERRIGO R AND DANDA 077351—Sep 25, 2006
FAMOTIDINE×2PERRIGO R AND DANDA 077352—Jul 27, 2005
FAMOTIDINEPERRIGOANDA 075400—Mar 18, 2005
FAMOTIDINEGLENMARK PHARMSANDA 077146—Mar 07, 2005
FAMOTIDINEPERRIGOANDA 075715—Aug 22, 2003
FAMOTIDINE PRESERVATIVE FREEEPIC PHARMA LLCANDA 076324—Nov 27, 2002
FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK)EPIC PHARMA LLCANDA 076322—Nov 27, 2002
FAMOTIDINESANDOZANDA 076101—Oct 21, 2002
FAMOTIDINEAPOTEX INCANDA 075942—Aug 02, 2002
FAMOTIDINEHIKMAANDA 075799—Apr 30, 2002
FAMOTIDINE PRESERVATIVE FREEHIKMAANDA 075789—Apr 30, 2002
FAMOTIDINEAPOTEXANDA 075610—Mar 12, 2002
FAMOTIDINENATCO PHARMAANDA 075674—Dec 21, 2001
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINERABBVIEANDA 075729—Dec 17, 2001
FAMOTIDINE×2SUN PHARM INDUSTRIESANDA 075639—Dec 12, 2001
FAMOTIDINEWATSON LABSANDA 075404—Nov 28, 2001
FAMOTIDINEHOSPIRAANDA 075870—Nov 23, 2001
FAMOTIDINEHOSPIRAANDA 075905—Nov 23, 2001
FAMOTIDINE×2ACTAVIS ELIZABETHANDA 075650—Sep 14, 2001
FAMOTIDINE×2DR REDDYS LABS LTDANDA 077367—Aug 17, 2001
FAMOTIDINEP AND LANDA 075512—Jul 26, 2001
FAMOTIDINE×2APOTEXANDA 075611—Jul 23, 2001
FAMOTIDINETEVAANDA 075312—May 31, 2001
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINERBAXTER HLTHCAREANDA 075591—May 10, 2001
FAMOTIDINE×2SANDOZANDA 075607—May 10, 2001
FAMOTIDINE×2MYLAN PHARMS INCANDA 075457—Apr 18, 2001
FAMOTIDINE PRESERVATIVE FREESAGENTANDA 075825APApr 17, 2001
FAMOTIDINEAPOTHECONANDA 075707—Apr 16, 2001
FAMOTIDINEFRESENIUS KABI USAANDA 075709APApr 16, 2001
FAMOTIDINEHIKMAANDA 075488APApr 16, 2001
FAMOTIDINEHOSPIRAANDA 075705—Apr 16, 2001
FAMOTIDINESAGENTANDA 075651APApr 16, 2001
FAMOTIDINESAGENTANDA 075684APApr 16, 2001
FAMOTIDINE PRESERVATIVE FREEAPOTHECONANDA 075708—Apr 16, 2001
FAMOTIDINE PRESERVATIVE FREEFRESENIUS KABI USAANDA 075813APApr 16, 2001
FAMOTIDINE PRESERVATIVE FREEHIKMAANDA 075486APApr 16, 2001
FAMOTIDINE PRESERVATIVE FREEHOSPIRAANDA 075669—Apr 16, 2001
FAMOTIDINE PRESERVATIVE FREESAGENTANDA 075622APApr 16, 2001
FAMOTIDINE×2CARLSBADANDA 075805ABApr 16, 2001
FAMOTIDINE×2CHARTWELL RXANDA 075786ABApr 16, 2001
FAMOTIDINE×2DR REDDYS LABS LTDANDA 075718ABApr 16, 2001
FAMOTIDINE×2IVAX SUB TEVA PHARMSANDA 075511ABApr 16, 2001
FAMOTIDINE×2MANKIND PHARMAANDA 075302ABApr 16, 2001
FAMOTIDINE×2RISINGANDA 075704ABApr 16, 2001
FAMOTIDINE×2SANDOZANDA 075793—Apr 16, 2001
FAMOTIDINE×2TEVAANDA 075311—Apr 16, 2001
FAMOTIDINE×2WATSON LABSANDA 075062—Apr 16, 2001

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Famotidine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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