NDA 17739, held by Insight Pharms. Miconazole Nitrate.
As of Nov 13, 2026, NDA 17739 (Monistat-Derm), held by Insight Pharms, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Monistat-Derm2% ยท lotion;topical | 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