Treats cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other…. ANDA 212557, held by Torrent. Nystatin.
As of Nov 14, 2026, ANDA 212557 (Nystatin), held by Torrent, was first approved by FDA on Jul 24, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 24, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nystatin100,000 UNITS/GM · cream;topical | Nystatin | Rx |
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
