Treats cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other…. ANDA 213566, held by Macleods Pharms. Nystatin.
As of Nov 14, 2026, ANDA 213566 (Nystatin), held by Macleods Pharms, was first approved by FDA on Aug 10, 2021, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & 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 |
|---|---|---|---|
| Aug 10, 2021 | 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
