ANDA 74423, held by Dava Pharms Inc. Captopril.
As of Nov 13, 2026, ANDA 74423 (Captopril), held by Dava Pharms 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 |
|---|---|---|---|
| Dec 12, 2001 | Supplement 3Manufacturing | Approved | None posted |
| Aug 27, 2001 | 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
