Treats candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. ANDA 90219, held by Glenmark Pharms. Clotrimazole.
As of Nov 15, 2026, ANDA 90219 (Clotrimazole), held by Glenmark Pharms, was first approved by FDA on Aug 3, 2010, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item 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 floccosum, and Microsporum canis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 3, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clotrimazole1% · cream;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
