Treats infections of the oral cavity caused by Candida albicans. ANDA 214346, held by Pharmazone. Nystatin.
As of Nov 14, 2026, ANDA 214346 (Nystatin), held by Pharmazone, was first approved by FDA on Mar 10, 2022, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 10, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nystatin100,000 UNITS/ML · suspension;oral | 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
