ANDA 74519, held by Chartwell Rx. Captopril.
As of Nov 13, 2026, ANDA 74519 (Captopril), held by Chartwell Rx, was first approved by FDA on Feb 13, 1996, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 1996 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 27, 1997 | Supplement 1Labeling | 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
