Treats candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. ANDA 209815, held by Novitium Pharma. Clotrimazole.
As of Nov 15, 2026, ANDA 209815 (Clotrimazole), held by Novitium Pharma, was first approved by FDA on Feb 15, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & 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 |
|---|---|---|---|
| Feb 15, 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
