ANDA 74395, held by Perrigo. Miconazole Nitrate.
As of Nov 15, 2026, ANDA 74395 (Miconazole Nitrate), held by Perrigo, was first approved by FDA on Mar 20, 1997, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 20, 1997 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Miconazole Nitrate100MG ยท suppository;vaginal | Miconazole Nitrate | Discontinued |
| Aug 27, 2002 | Supplement 3Labeling | Approved | None posted |
| Dec 30, 1998 | Supplement 2Manufacturing | Approved | None posted |
| Jan 20, 1998 | Supplement 1Manufacturing | Approved | None posted |
| Mar 20, 1997 | 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
