Treats cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other…. ANDA 219527, held by Aurobindo Pharma. Nystatin.
As of Nov 14, 2026, ANDA 219527 (Nystatin), held by Aurobindo Pharma, was first approved by FDA on Mar 21, 2025, 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 |
|---|---|---|---|
| Mar 21, 2025 | 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
