Treats cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans…. ANDA 62840, held by Actavis Mid Atlantic. Nystatin.
As of Nov 14, 2026, ANDA 62840 (Nystatin), held by Actavis Mid Atlantic, was first approved by FDA on Nov 13, 1987, with 9 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nystatin ointment, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other Candida species.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 13, 1987 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nystatin100,000 UNITS/GM · ointment;topical | Nystatin | Rx |
| May 30, 2001 | Supplement 11Manufacturing | Approved | None posted |
| Jan 18, 2000 | Supplement 10Manufacturing | Approved | None posted |
| Jun 1, 1998 | Supplement 8Manufacturing | Approved | None posted |
| Oct 25, 1995 | Supplement 7Manufacturing | Approved | None posted |
| Oct 25, 1995 | Supplement 6Manufacturing | Approved | None posted |
| Jun 19, 1995 | Supplement 5Manufacturing | Approved | None posted |
| Oct 11, 1994 | Supplement 4Manufacturing | Approved | None posted |
| May 29, 1992 | Supplement 3Manufacturing | Approved | None posted |
| May 9, 1988 | Supplement 2Manufacturing | Approved | None posted |
| Nov 13, 1987 | 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
