ANDA 76585, held by Cosette Pharms Nc. Miconazole Nitrate.
As of Nov 15, 2026, ANDA 76585 (Miconazole 7 Combination Pack), held by Cosette Pharms Nc, was first approved by FDA on Mar 26, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 26, 2004 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Miconazole 7 Combination Pack2%,100MG ยท cream, suppository;topical, vaginal | Miconazole Nitrate | 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
