Treats cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other…. ANDA 213826, held by Macleods Pharms. Nystatin.
As of Nov 14, 2026, ANDA 213826 (Nystatin), held by Macleods Pharms, was first approved by FDA on Jan 14, 2021, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nystatin Ointment, is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Ointment is not indicated for systemic, oral, intravaginal or ophthalmic use.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 14, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nystatin100,000 UNITS/GM · ointment;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
