ANDA 76790, held by Sun Pharma Canada. Ciclopirox.
As of Nov 15, 2026, ANDA 76790 (Ciclopirox), held by Sun Pharma Canada, was first approved by FDA on Apr 12, 2005, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 12, 2005 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ciclopirox0.77% · cream;topical | Ciclopirox | Rx |
| Jul 29, 2026 | Supplement 12Labeling · Standard review | Approved | None posted |
| Oct 27, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 12, 2005 | 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
