ANDA 74451, held by Watson Labs. Captopril.
As of Nov 13, 2026, ANDA 74451 (Captopril), held by Watson Labs, was first approved by FDA on Feb 13, 1996, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 1996 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 10, 2000 | Supplement 8Labeling | Approved | None posted |
| Mar 21, 2000 | Supplement 6Manufacturing | Approved | None posted |
| Jul 8, 1997 | Supplement 2Manufacturing | 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
