ANDA 65327, held by Apotex Inc. Cefprozil.
As of Nov 13, 2026, ANDA 65327 (Cefprozil), held by Apotex Inc, was first approved by FDA on Mar 26, 2008, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 26, 2008 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 1, 2017 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 26, 2008 | 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
