Treats cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other…. ANDA 64022, held by Sun Pharma Canada. Nystatin.
As of Nov 14, 2026, ANDA 64022 (Nystatin), held by Sun Pharma Canada, was first approved by FDA on Jan 29, 1993, with 2 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 |
|---|---|---|---|
| Jan 29, 1993 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nystatin100,000 UNITS/GM · cream;topical | Nystatin | Rx |
| Sep 17, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Apr 30, 1996 | Supplement 1Manufacturing | Approved | None posted |
| Jan 29, 1993 | 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
