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FDA Orange Book · active-ingredient family

Cefprozil

Cefprozil is approved as 2 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CEFZIL · NDA 050665

2

Brand (NDA)

16

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · for suspension, tablet

ProductApplicantApplicationTEApproved
CEFZILRLD×2CORDEN PHARMANDA 050665—Dec 23, 1991
CEFZILRLD×2CORDEN PHARMANDA 050664—Dec 23, 1991

Generic (ANDA) products (16)

ProductApplicantApplicationTEApproved
CEFPROZIL×2ALKEM LABS LTDANDA 090857ABApr 09, 2024
CEFPROZIL×2APOTEX INCANDA 065351—Feb 29, 2012
CEFPROZIL×2APOTEX INCANDA 065327—Mar 26, 2008
CEFPROZIL×2WOCKHARDTANDA 065428—Jun 14, 2007
CEFPROZIL×2AUROBINDO PHARMAANDA 065340ABMay 24, 2007
CEFPROZIL×2AUROBINDO PHARMAANDA 065381ABJan 30, 2007
CEFPROZIL×2RANBAXY LABS LTDANDA 065198—Dec 13, 2006
CEFPROZIL×2RANBAXY LABS LTDANDA 065202—Jun 30, 2006
CEFPROZIL×2ORCHID HLTHCAREANDA 065284—Dec 30, 2005
CEFPROZIL×2LUPINANDA 065261ABDec 19, 2005
CEFPROZIL×2ORCHID HLTHCAREANDA 065267—Dec 19, 2005
CEFPROZIL×2CHARTWELL RXANDA 065236—Dec 08, 2005
CEFPROZIL×2SANDOZANDA 065257—Dec 08, 2005
CEFPROZIL×2LUPINANDA 065276ABDec 08, 2005
CEFPROZIL×2TEVAANDA 065208ABDec 06, 2005
CEFPROZIL×2CHARTWELL RXANDA 065235ABNov 14, 2005

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.

Cefprozil — 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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