ANDA 78338, held by Fougera Pharms. Clotrimazole.
As of Nov 15, 2026, ANDA 78338 (Clotrimazole), held by Fougera Pharms, was first approved by FDA on Sep 2, 2008, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 2, 2008 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clotrimazole1% ยท 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
