Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 65340, held by Aurobindo Pharma. Cefprozil.
As of Nov 13, 2026, ANDA 65340 (Cefprozil), held by Aurobindo Pharma, was first approved by FDA on May 24, 2007, with 2 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 |
|---|---|---|---|
| May 24, 2007 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 15, 2017 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 5, 2008 | Supplement 1Labeling | Approved | None posted |
| May 24, 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
