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FDA Orange Book · active-ingredient family

Amoxicillin; clavulanate potassium

Amoxicillin; clavulanate potassium is approved as 8 brand and 41 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AUGMENTIN XR · NDA 050785

8

Brand (NDA)

41

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · for suspension, tablet, tablet, chewable, tablet, extended release

ProductApplicantApplicationTEApproved
AUGMENTIN XRRLDUS ANTIBIOTICSNDA 050785ABSep 25, 2002
AUGMENTIN ES-600RLDUS ANTIBIOTICSNDA 050755ABJun 22, 2001
AUGMENTIN '200'RLD×2US ANTIBIOTICSNDA 050725—May 31, 1996
AUGMENTIN '200'RLD×2US ANTIBIOTICSNDA 050726—May 31, 1996
AUGMENTIN '875'RLDUS ANTIBIOTICSNDA 050720ABFeb 13, 1996
AUGMENTIN '125'RLD×2US ANTIBIOTICSNDA 050597—Jul 22, 1985
AUGMENTIN '125'RLD×2US ANTIBIOTICSNDA 050575ABAug 06, 1984
AUGMENTIN '250'RLD×2US ANTIBIOTICSNDA 050564—Aug 06, 1984

Generic (ANDA) products (41)

ProductApplicantApplicationTEApproved
AMOXICILLIN AND CLAVULANATE POTASSIUMDEVA HOLDING ASANDA 210416ABDec 11, 2023
AMOXICILLIN AND CLAVULANATE POTASSIUMMICRO LABSANDA 217805ABDec 08, 2023
AMOXICILLIN AND CLAVULANATE POTASSIUMDEVA HOLDING ASANDA 210374ABNov 29, 2023
AMOXICILLIN AND CLAVULANATE POTASSIUMDEVA HOLDING ASANDA 209992ABSep 15, 2023
AMOXICILLIN AND CLAVULANATE POTASSIUMDEVA HOLDING ASANDA 209991ABSep 15, 2023
AMOXICILLIN AND CLAVULANATE POTASSIUMDEVA HOLDING ASANDA 209351ABSep 13, 2023
AMOXICILLIN AND CLAVULANATE POTASSIUM×2MICRO LABS LTD INDIAANDA 205187ABMay 21, 2021
AMOXICILLIN AND CLAVULANATE POTASSIUM×2AUROBINDO PHARMAANDA 209371ABApr 19, 2019
AMOXICILLIN AND CLAVULANATE POTASSIUM×2MICRO LABS LTD INDIAANDA 205707ABDec 30, 2016
AMOXICILLIN AND CLAVULANATE POTASSIUMMICRO LABS LTD INDIAANDA 204755ABDec 30, 2016
AMOXICILLIN AND CLAVULANATE POTASSIUMHIKMA PHARMSANDA 203824ABAug 23, 2016
AMOXICILLIN AND CLAVULANATE POTASSIUMCIPLAANDA 065420ABDec 02, 2013
AMOXICILLIN AND CLAVULANATE POTASSIUM×2AUROBINDO PHARMA LTDANDA 091569ABJan 20, 2012
AMOXICILLIN AND CLAVULANATE POTASSIUMAUROBINDO PHARMA LTDANDA 091568ABJan 20, 2012
AMOXICILLIN AND CLAVULANATE POTASSIUM×2AUROBINDO PHARMA LTDANDA 201090ABDec 20, 2011
AMOXICILLIN AND CLAVULANATE POTASSIUMAUROBINDO PHARMA LTDANDA 201091ABDec 20, 2011
AMOXICILLIN AND CLAVULANATE POTASSIUMSANDOZANDA 090227ABApr 21, 2010
AMOXICILLIN AND CLAVULANATE POTASSIUM×2APOTEX INCANDA 065333—Feb 24, 2009
AMOXICILLIN AND CLAVULANATE POTASSIUMCIPLAANDA 065431ABNov 25, 2008
AMOXICILLIN AND CLAVULANATE POTASSIUMAPOTEX INCANDA 065317—Oct 20, 2008
AMOXICILLIN AND CLAVULANATE POTASSIUMHIKMA PHARMSANDA 065373ABNov 09, 2007
AMOXICILLIN AND CLAVULANATE POTASSIUMSANDOZ INCANDA 065358ABAug 13, 2007
AMOXICILLIN AND CLAVULANATE POTASSIUMSUN PHARM INDS LTDANDA 065207—Jan 30, 2007
AMOXICILLIN AND CLAVULANATE POTASSIUMSANDOZANDA 065189ABAug 23, 2005
AMOXICILLIN AND CLAVULANATE POTASSIUM×2TEVAANDA 065205—Feb 09, 2005
AMOXICILLIN AND CLAVULANATE POTASSIUM×2HIKMA PHARMSANDA 065191ABJan 25, 2005
AMOXICILLIN AND CLAVULANATE POTASSIUM×2TEVAANDA 065089ABMay 25, 2004
AMOXICILLIN AND CLAVULANATE POTASSIUMTEVAANDA 065162ABMar 12, 2004
AMOXICILLIN AND CLAVULANATE POTASSIUM×2SUN PHARM INDS LTDANDA 065161—Dec 03, 2003
AMOXICILLIN AND CLAVULANATE POTASSIUM×2SUN PHARM INDS LTDANDA 065132—Mar 19, 2003
AMOXICILLIN AND CLAVULANATE POTASSIUM×2SANDOZ INCANDA 065098ABDec 16, 2002
AMOXICILLIN AND CLAVULANATE POTASSIUMSANDOZ INCANDA 065117—Nov 27, 2002
AMOXICILLIN AND CLAVULANATE POTASSIUMSANDOZ INCANDA 065093ABNov 21, 2002
AMOXICILLIN AND CLAVULANATE POTASSIUMSUN PHARM INDS LTDANDA 065109—Nov 04, 2002
AMOXICILLIN AND CLAVULANATE POTASSIUMTEVAANDA 065101ABOct 30, 2002
AMOXICILLIN AND CLAVULANATE POTASSIUMTEVA PHARMS USAANDA 065096ABOct 29, 2002
AMOXICILLIN AND CLAVULANATE POTASSIUMSUN PHARM INDS LTDANDA 065102—Sep 17, 2002
AMOXICILLIN AND CLAVULANATE POTASSIUM×2SANDOZANDA 065066ABJun 05, 2002
AMOXICILLIN AND CLAVULANATE POTASSIUM×2CHARTWELL RXANDA 065065—Apr 18, 2002
AMOXICILLIN AND CLAVULANATE POTASSIUMSANDOZANDA 065064ABMar 15, 2002
AMOXICILLIN AND CLAVULANATE POTASSIUMSANDOZANDA 065063ABMar 14, 2002

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.

Amoxicillin; clavulanate potassium — frequently asked questions

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

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