ANDA 65351, held by Apotex Inc. Cefprozil.
As of Nov 13, 2026, ANDA 65351 (Cefprozil), held by Apotex Inc, was first approved by FDA on Feb 29, 2012, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 29, 2012 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 12, 2017 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 29, 2012 | 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
