NDA 20389, held by Bayer Healthcare LLC. Clotrimazole.
As of Nov 14, 2026, NDA 20389 (Mycelex-7 Combination Pack), held by Bayer Healthcare LLC, was first approved by FDA on Jun 23, 1994, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 1994 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycelex-7 Combination Pack1%,100MG · cream, tablet;topical, vaginal | Clotrimazole | Discontinued |
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
