ANDA 74483, held by Cosette Pharms Nc. Captopril.
As of Nov 13, 2026, ANDA 74483 (Captopril), held by Cosette Pharms Nc, was first approved by FDA on Feb 13, 1996, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 1996 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 26, 2002 | Supplement 14Manufacturing | Approved | None posted |
| Aug 30, 2001 | Supplement 13Manufacturing | Approved | None posted |
| Jul 7, 2000 | Supplement 11Manufacturing | Approved | None posted |
| Apr 11, 2000 | Supplement 12Labeling | Approved | None posted |
| Feb 22, 2000 | Supplement 10Manufacturing | Approved | None posted |
| Jul 12, 1999 | Supplement 9Manufacturing | Approved | None posted |
| Jan 7, 1998 | Supplement 7Manufacturing | Approved | None posted |
| Oct 1, 1997 | Supplement 8Labeling | Approved | None posted |
| Apr 10, 1997 | Supplement 5Manufacturing | Approved | None posted |
| Jan 28, 1997 | Supplement 6Labeling | Approved | None posted |
| Dec 13, 1996 | Supplement 4Manufacturing | Approved | None posted |
| Aug 13, 1996 | Supplement 3Manufacturing | Approved | None posted |
| Aug 13, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Aug 13, 1996 | 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
