ANDA 60577, held by Delcor Asset Corp. Nystatin.
As of Nov 14, 2026, ANDA 60577 (Mycostatin), held by Delcor Asset Corp, was first approved by FDA on Jul 8, 1964, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 8, 1964 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycostatin100,000 UNITS ยท tablet;vaginal | Nystatin | Discontinued |
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
