Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 65276, held by Lupin. Cefprozil.
As of Nov 13, 2026, ANDA 65276 (Cefprozil), held by Lupin, was first approved by FDA on Dec 8, 2005, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Cefprozil tablets are 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 8, 2005 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 9, 2018 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jan 16, 2008 | Supplement 3Labeling | Approved | None posted |
| Dec 8, 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
