ANDA 65236, held by Chartwell Rx. Cefprozil.
As of Nov 13, 2026, ANDA 65236 (Cefprozil), held by Chartwell Rx, was first approved by FDA on Dec 8, 2005, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 8, 2005 | Original application | Approved |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 25, 2025 | Supplement 7Labeling · Standard review | Approved | None posted |
| Apr 9, 2018 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 4, 2009 | Supplement 5Labeling | Approved | None posted |
| Dec 8, 2005 | Original application | Approved |
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
