Treats candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. ANDA 212281, held by Tp Anda Holdings. Clotrimazole.
As of Nov 15, 2026, ANDA 212281 (Clotrimazole), held by Tp Anda Holdings, was first approved by FDA on Jul 25, 2019, 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 |
|---|---|---|---|
| Jul 25, 2019 | 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
