Treats cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other…. ANDA 210532, held by Epic Pharma LLC. Nystatin.
As of Nov 14, 2026, ANDA 210532 (Klayesta), held by Epic Pharma LLC, was first approved by FDA on Apr 30, 2018, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE KLAYESTA is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. KLAYESTA is not indicated for systemic, oral, intravaginal or ophthalmic use.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 30, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Klayesta100,000 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
