Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 65261, held by Lupin. Cefprozil.
As of Nov 13, 2026, ANDA 65261 (Cefprozil), held by Lupin, was first approved by FDA on Dec 19, 2005, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Cefprozil for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Upper Respiratory Tract: Pharyngitis/Tonsillitis: Caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 2005 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 22, 2025 | Supplement 21Manufacturing | Approved | None posted |
| Apr 9, 2018 | Supplement 15Labeling · Standard review | Approved | None posted |
| Jan 7, 2008 | Supplement 6Labeling | Approved | None posted |
| Jul 27, 2007 | Supplement 2Labeling | Approved | None posted |
| Dec 19, 2005 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
