Treats cutaneous or mucocutaneous mycotic infections caused by Candida. ANDA 62472, held by Padagis US. Nystatin.
As of Nov 14, 2026, ANDA 62472 (Nystatin), held by Padagis US, was first approved by FDA on Feb 13, 1984, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nystatin Ointment USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia] albicans and other Candida species.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 1984 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nystatin100,000 UNITS/GM · ointment;topical | Nystatin | Rx |
| Apr 17, 2009 | Supplement 4Labeling | Approved | None posted |
| Sep 5, 2000 | Supplement 2Manufacturing | Approved | None posted |
| Apr 6, 1994 | Supplement 1Labeling | Approved | None posted |
| Feb 13, 1984 | 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
