Treats cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other…. ANDA 64118, held by Padagis US. Nystatin.
As of Nov 14, 2026, ANDA 64118 (Nystop), held by Padagis US, was first approved by FDA on Aug 16, 1996, with 12 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 16, 1996 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nystop100,000 UNITS/GM · powder;topical | Nystatin | Rx |
| Nov 13, 2002 | Supplement 11Manufacturing | Approved | None posted |
| Nov 13, 2002 | Supplement 12Labeling | Approved | None posted |
| Sep 8, 2000 | Supplement 10Labeling | Approved | None posted |
| Sep 21, 1998 | Supplement 8Manufacturing | Approved | None posted |
| Sep 21, 1998 | Supplement 9Manufacturing | Approved | None posted |
| Jul 10, 1998 | Supplement 4Manufacturing | Approved | None posted |
| Jul 10, 1998 | Supplement 5Labeling | Approved | None posted |
| Jul 10, 1998 | Supplement 6Manufacturing | Approved | None posted |
| Apr 20, 1998 | Supplement 7Manufacturing | Approved | None posted |
| Jul 30, 1997 | Supplement 3Manufacturing | Approved | None posted |
| Jul 17, 1997 | Supplement 2Manufacturing | Approved | None posted |
| Feb 10, 1997 | Supplement 1Manufacturing | Approved | None posted |
| Aug 16, 1996 | Original application | Approved |
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
