ANDA 73249, held by Teva Pharms. Clotrimazole.
As of Nov 15, 2026, ANDA 73249 (Gynix), held by Teva Pharms, was first approved by FDA on Feb 13, 1998, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gynix100MG ยท tablet;vaginal | Clotrimazole | Discontinued |
| Mar 23, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Feb 13, 1998 | Original application | Approved |
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