ANDA 74164, held by Encube. Miconazole Nitrate.
As of Nov 15, 2026, ANDA 74164 (Miconazole 7), held by Encube, was first approved by FDA on Mar 29, 1996, with 13 approved supplements and 0 published complete response letters.
Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 1996 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Miconazole 72% · cream;vaginal | Miconazole Nitrate | OTC |
| Apr 27, 2022 | Supplement 33Labeling · Standard review | Approved | None posted |
| Jun 8, 2015 | Supplement 27Manufacturing | Approved | None posted |
| Mar 24, 2015 | Supplement 22Labeling | Approved | None posted |
| Mar 24, 2015 | Supplement 25Labeling · Standard review | Approved | None posted |
| Nov 19, 2001 | Supplement 10Labeling | Approved | None posted |
| Dec 29, 2000 | Supplement 8Manufacturing | Approved | None posted |
| Feb 17, 2000 | Supplement 6Manufacturing | Approved | None posted |
| Dec 27, 1999 | Supplement 7Manufacturing | Approved | None posted |
| Oct 18, 1996 | Supplement 1Manufacturing | Approved | None posted |
| Oct 18, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Oct 18, 1996 | Supplement 3Manufacturing | Approved | None posted |
| Oct 18, 1996 | Supplement 4Manufacturing | Approved | None posted |
| Jun 28, 1996 | Supplement 5Manufacturing | Approved | None posted |
| Mar 29, 1996 | Original application | Approved | None posted |
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
