ANDA 76773, held by Sun Pharma Canada. Miconazole Nitrate.
As of Nov 15, 2026, ANDA 76773 (Miconazole 3), held by Sun Pharma Canada, was first approved by FDA on Mar 2, 2005, with 0 approved supplements and 0 published complete response letters.
Use treats vaginal yeast infections
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 2, 2005 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Miconazole 34% · cream;vaginal | Miconazole Nitrate | OTC |
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
