ANDA 61718, held by Holland Rantos. Nystatin.
As of Nov 14, 2026, ANDA 61718 (Korostatin), held by Holland Rantos, was first approved by FDA on Sep 30, 1974, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 30, 1974 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Korostatin100,000 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
