Treats cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other…. ANDA 62225, held by Padagis US. Nystatin.
As of Nov 14, 2026, ANDA 62225 (Nystatin), held by Padagis US, was first approved by FDA on Dec 11, 1979, with 8 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nystatin Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Cream USP is not indicated for systemic, oral, intravaginal or ophthalmic use.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 11, 1979 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nystatin100,000 UNITS/GM · cream;topical | Nystatin | Rx |
| Dec 3, 2009 | Supplement 11Labeling | Approved | None posted |
| Apr 17, 2009 | Supplement 10Labeling | Approved | None posted |
| Sep 5, 2000 | Supplement 8Manufacturing | Approved | None posted |
| Jun 15, 1995 | Supplement 7Manufacturing | Approved | None posted |
| Jun 15, 1995 | Supplement 6Manufacturing | Approved | None posted |
| Jul 6, 1994 | Supplement 4Labeling | Approved | None posted |
| Oct 4, 1993 | Supplement 5Labeling | Approved | None posted |
| Mar 18, 1988 | Supplement 3Manufacturing | Approved | None posted |
| Dec 11, 1979 | 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
