Treats cutaneous or mucocutaneous mycotic infections caused by Candidaalbicans and other…. ANDA 209114, held by Cosette. Nystatin.
As of Nov 14, 2026, ANDA 209114 (Nystatin), held by Cosette, was first approved by FDA on Oct 6, 2017, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Nystatin Ointment, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candidaalbicans and other susceptible Candidaspecies. Nystatin Ointment, USP is not indicated for systemic, oral, intravaginal or ophthalmic use.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 6, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nystatin100,000 UNITS/GM · ointment;topical | Nystatin | Rx |
| Apr 23, 2019 | Supplement 1Manufacturing | Approved | None posted |
| Oct 6, 2017 | Original application | Approved | None posted |
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
