Treats candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. ANDA 216569, held by Sciegen Pharms. Clotrimazole.
As of Nov 15, 2026, ANDA 216569 (Clotrimazole), held by Sciegen Pharms, was first approved by FDA on Oct 16, 2023, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. This formulation is also available as a nonprescription product which 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 fluoccosum, and Microsporum canis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 16, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clotrimazole1% · solution;topical | Clotrimazole | Rx |
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
