Treats candidiasis in the oral cavity. ANDA 203621, held by Pharm Assoc. Nystatin.
As of Nov 14, 2026, ANDA 203621 (Nystatin), held by Pharm Assoc, was first approved by FDA on Jan 7, 2016, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 7, 2016 | 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
