Treats candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. ANDA 74580, held by Sun Pharma Canada. Clotrimazole.
As of Nov 15, 2026, ANDA 74580 (Clotrimazole), held by Sun Pharma Canada, was first approved by FDA on Jul 29, 1996, with 4 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 29, 1996 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clotrimazole1% · solution;topical | Clotrimazole | Rx |
| Sep 11, 2003 | Supplement 6Labeling | Approved | None posted |
| Nov 4, 2002 | Supplement 4Manufacturing | Approved | None posted |
| Jan 18, 2001 | Supplement 3Manufacturing | Approved | None posted |
| Dec 8, 1997 | Supplement 2Manufacturing | Approved | None posted |
| Jul 29, 1996 | Original application | Approved | None posted |
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
