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FDA Orange Book · active-ingredient family

Ranitidine hydrochloride

Ranitidine hydrochloride is approved as 9 brand and 75 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ZANTAC 150 · NDA 021698

9

Brand (NDA)

75

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, granule, effervescent, injectable, syrup, tablet, tablet, effervescent

ProductApplicantApplicationTEApproved
ZANTAC 150RLD×2CHATTEM SANOFINDA 021698—Aug 31, 2004
ZANTAC 75RLDCHATTEM SANOFINDA 020745—Feb 26, 1998
ZANTAC 75RLDCHATTEM SANOFINDA 020520—Dec 19, 1995
ZANTAC 150RLD×2GLAXOSMITHKLINENDA 020095—Mar 08, 1994
ZANTACRLDGLAXO GRP LTDNDA 019675—Dec 30, 1988
ZANTACRLDPAI HOLDINGS PHARMNDA 019090—Oct 19, 1984
ZANTAC 150RLD×2GLAXO GRP LTDNDA 018703—Jun 09, 1983
ZANTAC 150×3GLAXO GRP LTDNDA 020251—Mar 31, 1994
ZANTAC IN PLASTIC CONTAINER×2PAI HOLDINGS PHARMNDA 019593—Sep 27, 1991

Generic (ANDA) products (75)

ProductApplicantApplicationTEApproved
RANITIDINE HYDROCHLORIDETHINQ PHARM-CRO PVTANDA 210250—Aug 30, 2019
RANITIDINE HYDROCHLORIDETHINQ PHARM-CRO PVTANDA 210228—Aug 30, 2019
RANITIDINE HYDROCHLORIDE×2APPCOANDA 211893—Apr 05, 2019
RANITIDINE HYDROCHLORIDE×2VKT PHARMAANDA 211289ABJan 31, 2019
RANITIDINE HYDROCHLORIDE×2NOVITIUM PHARMAANDA 210681—Nov 23, 2018
RANITIDINE HYDROCHLORIDE×2AJANTA PHARMA LTDANDA 209859—Sep 27, 2018
RANITIDINE HYDROCHLORIDE×2GRANULESANDA 210243—Aug 20, 2018
RANITIDINE HYDROCHLORIDE×2STRIDES PHARMAANDA 210010—Aug 01, 2018
RANITIDINE HYDROCHLORIDE×2AUROBINDO PHARMAANDA 211058—Jul 16, 2018
RANITIDINE HYDROCHLORIDESTRIDES PHARMAANDA 209160—Mar 05, 2018
RANITIDINE HYDROCHLORIDESTRIDES PHARMAANDA 209161—Feb 22, 2018
RANITIDINE HYDROCHLORIDE×2MPP PHARMAANDA 203694—Nov 30, 2017
RANITIDINE HYDROCHLORIDEAUROBINDO PHARMAANDA 207579—Nov 13, 2017
RANITIDINE HYDROCHLORIDEAUROBINDO PHARMAANDA 207578—Nov 13, 2017
RANITIDINE HYDROCHLORIDE×2STRIDES PHARMAANDA 205512—Aug 22, 2016
RANITIDINE HYDROCHLORIDEMYLAN LABS LTDANDA 079076—Jun 09, 2016
RANITIDINE HYDROCHLORIDEZYDUS PHARMS USA INCANDA 091534—Feb 22, 2013
RANITIDINE HYDROCHLORIDEAPOTEX INCANDA 200172—May 31, 2012
RANITIDINE HYDROCHLORIDESTRIDES PHARMAANDA 201745—Feb 29, 2012
RANITIDINE HYDROCHLORIDENOSTRUM LABS INCANDA 091091—Sep 20, 2011
RANITIDINE HYDROCHLORIDESTRIDES PHARMAANDA 200536—Jun 28, 2011
RANITIDINE HYDROCHLORIDESUN PHARMA CANADAANDA 077476—Jun 13, 2011
RANITIDINE HYDROCHLORIDE×2PERRIGO R AND DANDA 091429—May 11, 2011
RANITIDINE HYDROCHLORIDEEPIC PHARMA LLCANDA 091078—Mar 22, 2011
RANITIDINE HYDROCHLORIDELANNETT CO INCANDA 091288—Dec 09, 2010
RANITIDINE HYDROCHLORIDETOLMARANDA 090054—Nov 15, 2010
RANITIDINE HYDROCHLORIDEAUROBINDO PHARMAANDA 090623—Jul 28, 2010
RANITIDINE HYDROCHLORIDELANNETT CO INCANDA 078890—Jul 01, 2010
RANITIDINE HYDROCHLORIDE×2WOCKHARDTANDA 078701—Nov 12, 2009
RANITIDINE HYDROCHLORIDENOSTRUM LABS INCANDA 078684—Aug 27, 2009
RANITIDINE HYDROCHLORIDETORRENTANDA 090102—May 26, 2009
RANITIDINE HYDROCHLORIDEWOCKHARDTANDA 079211—May 26, 2009
RANITIDINE HYDROCHLORIDEWOCKHARDTANDA 079212—Feb 23, 2009
RANITIDINE HYDROCHLORIDE×2GLENMARK PHARMSANDA 078542—Nov 19, 2008
RANITIDINE HYDROCHLORIDEAMNEAL PHARMSANDA 078312—Sep 02, 2008
RANITIDINE HYDROCHLORIDEWOCKHARDTANDA 078884—Jul 31, 2008
RANITIDINE HYDROCHLORIDERANBAXYANDA 078448—Dec 13, 2007
RANITIDINE HYDROCHLORIDEWOCKHARDTANDA 078653—Nov 26, 2007
RANITIDINE HYDROCHLORIDEPHARM ASSOCANDA 077405—Sep 21, 2007
RANITIDINE HYDROCHLORIDEAPOTEX INCANDA 077602—Sep 17, 2007
RANITIDINE HYDROCHLORIDEDR REDDYS LABS LTDANDA 078192—Aug 31, 2007
RANITIDINE HYDROCHLORIDEACTAVIS MID ATLANTICANDA 076124—Feb 21, 2007
RANITIDINE HYDROCHLORIDE×2AMNEAL PHARMS NYANDA 077824—Oct 13, 2006
RANITIDINE HYDROCHLORIDEWOCKHARDTANDA 076760—Feb 24, 2006
RANITIDINE HYDROCHLORIDEHIKMAANDA 077458—Feb 16, 2006
RANITIDINE HYDROCHLORIDE×2ANI PHARMSANDA 077426—Dec 19, 2005
RANITIDINE HYDROCHLORIDE×2DR REDDYS LABS INCANDA 076705ABJul 27, 2005
RANITIDINE HYDROCHLORIDEHIKMAANDA 074777—Mar 02, 2005
RANITIDINE HYDROCHLORIDEBEDFORDANDA 074764—Nov 19, 2004
RANITIDINE HYDROCHLORIDE×2TEVAANDA 075557—Oct 31, 2003
RANITIDINE HYDROCHLORIDESANDOZANDA 075519—Sep 26, 2002
RANITIDINE HYDROCHLORIDEPERRIGOANDA 076195—Aug 30, 2002
RANITIDINE HYDROCHLORIDE×2DR REDDYS LABS LTDANDA 075742ABNov 29, 2000
RANITIDINE HYDROCHLORIDE×2RISINGANDA 075564—Oct 27, 2000
RANITIDINE HYDROCHLORIDEAPOTEXANDA 075167—May 04, 2000
RANITIDINE HYDROCHLORIDE×2SUN PHARM INDS LTDANDA 075439—Apr 19, 2000
RANITIDINE HYDROCHLORIDEDR REDDYS LABS LTDANDA 075294—Mar 28, 2000
RANITIDINE HYDROCHLORIDEANI PHARMSANDA 075212—Jan 14, 2000
RANITIDINE HYDROCHLORIDEANI PHARMSANDA 075296—Jan 14, 2000
RANITIDINE HYDROCHLORIDERANBAXYANDA 075254—Jan 14, 2000
RANITIDINE HYDROCHLORIDERISINGANDA 075497—Jan 14, 2000
RANITIDINE HYDROCHLORIDESUN PHARM INDS LTDANDA 075132—Jan 14, 2000
RANITIDINE HYDROCHLORIDECONTRACT PHARMACALANDA 075094—Jun 21, 1999
RANITIDINE HYDROCHLORIDE×2PH HEALTHANDA 075180—Jan 28, 1999
RANITIDINE HYDROCHLORIDE×2WOCKHARDT LTDANDA 075208—Dec 17, 1998
RANITIDINE HYDROCHLORIDE×2HERITAGE PHARMA AVETANDA 075165—Sep 30, 1998
RANITIDINE HYDROCHLORIDE×2PHARMOBEDIENTANDA 074552—Jul 30, 1998
RANITIDINE HYDROCHLORIDE×2RANBAXYANDA 075000—Jan 30, 1998
RANITIDINE HYDROCHLORIDE×2SANDOZANDA 074655ABOct 22, 1997
RANITIDINE HYDROCHLORIDE×2WATSON LABSANDA 074864—Oct 20, 1997
RANITIDINE HYDROCHLORIDE×2APOTEXANDA 074680—Sep 12, 1997
RANITIDINE HYDROCHLORIDE×2BOEHRINGER INGELHEIMANDA 074662—Aug 29, 1997
RANITIDINE HYDROCHLORIDE×2SANDOZANDA 074467ABAug 29, 1997
RANITIDINE HYDROCHLORIDE×2MYLANANDA 074023—Aug 22, 1997
RANITIDINE HYDROCHLORIDE×2ANI PHARMSANDA 074488—Jul 31, 1997

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.

Ranitidine hydrochloride — frequently asked questions

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

Agent CTA Background

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