ANDA 62524, held by Chartwell Rx. Nystatin.
As of Nov 14, 2026, ANDA 62524 (Nystatin), held by Chartwell Rx, was first approved by FDA on Nov 26, 1985, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 26, 1985 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nystatin500,000 UNITS ยท tablet;oral | Nystatin | Discontinued |
| Jul 16, 1993 | Supplement 7Manufacturing | Approved | None posted |
| Sep 11, 1992 | Supplement 8Labeling | Approved | None posted |
| Nov 26, 1985 | 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
