ANDA 65235, held by Chartwell Rx. Cefprozil.
As of Nov 13, 2026, ANDA 65235 (Cefprozil), held by Chartwell Rx, was first approved by FDA on Nov 14, 2005, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 14, 2005 | Original application | Approved |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 12, 2017 | Supplement 13Labeling · Standard review | Approved | None posted |
| Oct 8, 2008 | Supplement 8Labeling | Approved | None posted |
| Oct 11, 2006 | Supplement 2Labeling | Approved | None posted |
| Nov 14, 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
