Assyro AI

FDA Orange Book · active-ingredient family

Metronidazole

Metronidazole is approved as 29 brand and 62 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LIKMEZ · NDA 216755

29

Brand (NDA)

62

Generics (ANDA)

9

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, cream, gel, injectable, lotion, suspension, tablet, tablet, extended release

ProductApplicantApplicationTEApproved
LIKMEZRLDSAPTALIS PHARMSNDA 216755—Sep 22, 2023
NUVESSARLDALEMBIC THERAPNDA 205223—Mar 24, 2014
METROGELRLDGALDERMA LABS LPNDA 021789ABJun 30, 2005
METROLOTIONRLDGALDERMA LABS LPNDA 020901ABNov 24, 1998
FLAGYL ERRLDPFIZERNDA 020868—Nov 26, 1997
NORITATERLDBAUSCHNDA 020743—Sep 26, 1997
METROCREAMRLDGALDERMA LABS LPNDA 020531ABSep 20, 1995
FLAGYLRLDPFIZERNDA 020334ABMay 03, 1995
METROGEL-VAGINALRLDBAUSCHNDA 020208—Aug 17, 1992
METROGELRLDGALDERMA LABS LPNDA 019737—Nov 22, 1988
METRONIDAZOLE IN PLASTIC CONTAINERRLDHOSPIRANDA 018890APNov 18, 1983
METRO I.V. IN PLASTIC CONTAINERRLDB BRAUNNDA 018900—Sep 29, 1983
FLAGYL I.V. RTU IN PLASTIC CONTAINERRLDBAXTER HLTHCARENDA 018657APApproved Prior to Jan 1, 1982
FLAGYLRLD×2PFIZERNDA 012623—Approved Prior to Jan 1, 1982
VANDAZOLETEVA PHARMSNDA 021806BXMay 20, 2005
METRONIDAZOLELNKNDA 019029—Apr 10, 1984
METRONIDAZOLEHIKMANDA 018907—Mar 30, 1984
METRONIDAZOLEABBOTTNDA 018889—Nov 18, 1983
METRONIDAZOLECHARTWELL MOLECULESNDA 018845—Aug 18, 1983
METRONIDAZOLECHARTWELL MOLECULESNDA 018930—Aug 18, 1983
PROTOSTAT×2ORTHO MCNEIL PHARMNDA 018871—Mar 02, 1983
METRONIDAZOLE×2MUTUAL PHARMNDA 018818—Feb 16, 1983
METRONIDAZOLE×2FOSUN PHARMANDA 018740—Oct 22, 1982
METRONIDAZOLE×2WATSON LABSNDA 018599—Sep 17, 1982
METRONIDAZOLE×2WATSON LABSNDA 018764—Sep 17, 1982
METRO I.V.B BRAUNNDA 018674—Aug 31, 1982
METRONIDAZOLE×2FOSUN PHARMANDA 018620—Mar 04, 1982
FLAGYL I.V. RTU IN PLASTIC CONTAINERPFIZERNDA 018353—Approved Prior to Jan 1, 1982
METRONIDAZOLE×2IVAX SUB TEVA PHARMSNDA 018517—Approved Prior to Jan 1, 1982

Generic (ANDA) products (62)

ProductApplicantApplicationTEApproved
METRONIDAZOLEZYDUS LIFESCIENCESANDA 220095ABFeb 13, 2026
METRONIDAZOLEAUROBINDO PHARMA LTDANDA 219295ABJul 09, 2025
METRONIDAZOLESCIEGEN PHARMSANDA 216750ABDec 31, 2024
METRONIDAZOLE×3INNOGENIXANDA 070772—Oct 29, 2024
METRONIDAZOLEAUROBINDO PHARMA LTDANDA 218941ABOct 15, 2024
METRONIDAZOLEENCUBEANDA 216795—Mar 18, 2024
METRONIDAZOLECOSETTE PHARMS NCANDA 216323ABJul 12, 2023
METRONIDAZOLEENCUBEANDA 215610ABJun 16, 2023
METRONIDAZOLE IN PLASTIC CONTAINERAMNEALANDA 217665APMay 24, 2023
METRONIDAZOLEZYDUS LIFESCIENCESANDA 217128BXApr 21, 2023
METRONIDAZOLECOSETTE PHARMS NCANDA 216692ABJan 23, 2023
METRONIDAZOLEGLENMARK PHARMS LTDANDA 215794ABJan 27, 2022
METRONIDAZOLESOLARIS PHARMA CORPANDA 213648ABOct 14, 2021
METRONIDAZOLEALEMBICANDA 212646ABSep 03, 2021
METRONIDAZOLE IN PLASTIC CONTAINERGLANDANDA 212435APAug 03, 2020
METRONIDAZOLEPADAGIS ISRAELANDA 211786ABJul 02, 2019
METRONIDAZOLE IN PLASTIC CONTAINERINFORLIFEANDA 206191APFeb 25, 2019
METRONIDAZOLE×2CADILA PHARMS LTDANDA 209794ABDec 12, 2017
METRONIDAZOLE×2LUPINANDA 209096—Sep 12, 2017
METRONIDAZOLE×2ALEMBICANDA 208681ABJun 20, 2017
METRONIDAZOLE IN PLASTIC CONTAINERRISINGANDA 205531—May 09, 2017
METRONIDAZOLETAROANDA 204651ABMar 14, 2017
METRONIDAZOLE×2CADILAANDA 206560ABNov 16, 2016
METRONIDAZOLE×2NOVITIUM PHARMAANDA 208162ABMay 25, 2016
METRONIDAZOLE×2FLAMINGO PHARMSANDA 207309—May 16, 2016
METRONIDAZOLE×2SOMERSET THERAPS LLCANDA 205245ABSep 23, 2015
METRONIDAZOLE×2AUROBINDO PHARMA LTDANDA 203974ABMay 29, 2015
METRONIDAZOLE×2UNICHEMANDA 203458ABJan 22, 2014
METRONIDAZOLECHARTWELL RXANDA 090903—Jul 22, 2011
METRONIDAZOLECOSETTE PHARMS NCANDA 078178ABJan 19, 2011
METRONIDAZOLEALEMBICANDA 090222—May 05, 2010
METRONIDAZOLEALEMBICANDA 079065ABJun 23, 2009
METRONIDAZOLE×2ALEMBIC PHARMS LTDANDA 079067ABMar 13, 2009
METRONIDAZOLE IN PLASTIC CONTAINERBAXTER HLTHCARE CORPANDA 078084—Mar 31, 2008
METRONIDAZOLECOSETTE PHARMS NCANDA 077549ABDec 19, 2007
METRONIDAZOLEENCUBEANDA 077264—Oct 31, 2006
METRONIDAZOLETAROANDA 077819ABJul 18, 2006
METRONIDAZOLEENCUBEANDA 077547ABJul 13, 2006
METRONIDAZOLEFOUGERA PHARMSANDA 077018ABJun 06, 2006
METRONIDAZOLEFOUGERA PHARMSANDA 077197ABMay 24, 2006
METRONIDAZOLEFOUGERA PHARMSANDA 076408ABMay 28, 2004
METRONIDAZOLECHARTWELL RXANDA 076522ABJan 29, 2004
METRONIDAZOLEABLEANDA 076505—Nov 13, 2003
METRONIDAZOLE×2ABLEANDA 076519—Jun 27, 2003
METRONIDAZOLEABLEANDA 076462—Jun 25, 2003
METROMIDOL×2LABS AFANDA 074523—Oct 24, 1996
SATRICSAVAGE LABSANDA 070731—Jun 08, 1987
METRONIDAZOLEWATSON LABSANDA 070170—Apr 01, 1986
METRONIDAZOLEHALSEYANDA 070593—Feb 27, 1986
METRONIDAZOLEINTL MEDICATIONANDA 070004—May 08, 1985
METRONIDAZOLEHALSEYANDA 070021—Apr 02, 1985
SATRICSAVAGE LABSANDA 070029—Mar 19, 1985
METRONIDAZOLEWATSON LABS INCANDA 070044ABFeb 08, 1985
METRONIDAZOLESTRIDES PHARMAANDA 070040—Jan 29, 1985
METRONIDAZOLESTRIDES PHARMAANDA 070039—Jan 29, 1985
METRONIDAZOLEWATSON LABSANDA 070042—Dec 20, 1984
METRONIDAZOLEWATSON LABSANDA 070035ABDec 20, 1984
METRONIDAZOLESUPERPHARMANDA 070008—Dec 11, 1984
METRONIDAZOLESUPERPHARMANDA 070009—Dec 11, 1984
METRONIDAZOLEPLIVAANDA 070033ABDec 06, 1984
METRONIDAZOLEABRAXIS PHARMANDA 070071—Dec 03, 1984
METRONIDAZOLETEVA PHARMS USAANDA 070027ABNov 06, 1984

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8877792Feb 02, 2028in 1 yr 8 mo
Product
7893097Feb 19, 2028in 1 yr 8 mo
Product
8658678Jun 27, 2028in 2 yr 1 mo
U-1682
9198858Jun 28, 2032in 6 yr 1 mo
U-1664
8946276Jun 28, 2032in 6 yr 1 mo
U-1664
10238634Jun 28, 2032in 6 yr 1 mo
Product
10596155Jun 28, 2032in 6 yr 1 mo
Product
12257236Jan 16, 2039in 12 yr 9 mo
ProductU-3169
11541035Oct 04, 2039in 13 yr 6 mo
Product

Metronidazole — 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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