ANDA 74477, held by Prinston Inc. Captopril.
As of Nov 13, 2026, ANDA 74477 (Captopril), held by Prinston Inc, was first approved by FDA on Feb 13, 1996, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 1996 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 19, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 21, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Feb 13, 1996 | 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
