Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 90857, held by Alkem Labs Ltd. Cefprozil.
As of Nov 13, 2026, ANDA 90857 (Cefprozil), held by Alkem Labs Ltd, was first approved by FDA on Apr 9, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Cefprozil 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 |
|---|---|---|---|
| Apr 9, 2024 | 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
