FDA Orange Book · active-ingredient family
Cefprozil
Cefprozil: 2 brands, 16 generics; first approved Dec 23, 1991; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
16
Listed patents
0
Presentations
36
Brand (NDA) products
Originator applications
- CEFZILRLDCORDEN PHARMANDA 05066519912 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Discontinued — 250MG/5ML FOR SUSPENSION ORAL Discontinued — - CEFZILRLDCORDEN PHARMANDA 05066419912 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued —
Generic (ANDA) products (16)
Abbreviated applications
- CEFPROZILALKEM LABS LTDANDA 09085720242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CEFPROZILAPOTEX INCANDA 06535120122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Discontinued — 250MG/5ML FOR SUSPENSION ORAL Discontinued — - CEFPROZILAPOTEX INCANDA 06532720082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - CEFPROZILWOCKHARDTANDA 06542820072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - CEFPROZILAUROBINDO PHARMAANDA 06534020072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CEFPROZILAUROBINDO PHARMAANDA 06538120072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Rx AB 250MG/5ML FOR SUSPENSION ORAL Rx AB - CEFPROZILRANBAXY LABS LTDANDA 06519820062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - CEFPROZILRANBAXY LABS LTDANDA 06520220062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Discontinued — 250MG/5ML FOR SUSPENSION ORAL Discontinued — - CEFPROZILORCHID HLTHCAREANDA 06528420052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML FOR SUSPENSION ORAL Discontinued — 125MG/5ML FOR SUSPENSION ORAL Discontinued — - CEFPROZILLUPINANDA 06526120052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Rx AB 250MG/5ML FOR SUSPENSION ORAL Rx AB - CEFPROZILORCHID HLTHCAREANDA 06526720052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - CEFPROZILCHARTWELL RXANDA 06523620052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Discontinued — 250MG/5ML FOR SUSPENSION ORAL Discontinued — - CEFPROZILSANDOZANDA 06525720052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Discontinued — 250MG/5ML FOR SUSPENSION ORAL Discontinued — - CEFPROZILLUPINANDA 06527620052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CEFPROZILTEVAANDA 06520820052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CEFPROZILCHARTWELL RXANDA 06523520052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
35 yr 2 mo ago
Most recent approval
2 yr 5 mo ago
Approvals span 1991–2024 across 18 FDA applications.
Brand (NDA) 211%
Generic (ANDA) 1689%
Cefprozil: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
