Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 65381, held by Aurobindo Pharma. Cefprozil.
As of Nov 13, 2026, ANDA 65381 (Cefprozil), held by Aurobindo Pharma, was first approved by FDA on Jan 30, 2007, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 30, 2007 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 15, 2025 | Supplement 11Labeling · Standard review | Approved | None posted |
| May 15, 2017 | Supplement 8Labeling · Standard review | Approved | None posted |
| Apr 3, 2009 | Supplement 3Labeling | Approved | None posted |
| Feb 5, 2008 | Supplement 1Labeling | Approved | None posted |
| Jan 30, 2007 | 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
