Treats cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other…. ANDA 208581, held by Zydus Pharms. Nystatin.
As of Nov 14, 2026, ANDA 208581 (Nystatin), held by Zydus Pharms, was first approved by FDA on Jun 8, 2017, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 8, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nystatin100,000 UNITS/GM · powder;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
