ANDA 73507, held by Cosette Pharms Nc. Miconazole Nitrate.
As of Nov 15, 2026, ANDA 73507 (Miconazole Nitrate), held by Cosette Pharms Nc, was first approved by FDA on Nov 19, 1993, with 15 approved supplements and 0 published complete response letters.
Use treats vaginal yeast infections
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 19, 1993 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Miconazole Nitrate100MG · suppository;vaginal | Miconazole Nitrate | OTC |
| Apr 22, 2005 | Supplement 16Labeling | Approved | None posted |
| Feb 20, 2004 | Supplement 15Labeling | Approved | None posted |
| Nov 21, 2002 | Supplement 14Labeling | Approved | None posted |
| Jan 8, 2002 | Supplement 13Manufacturing | Approved | None posted |
| Dec 29, 2000 | Supplement 12Manufacturing | Approved | None posted |
| Aug 30, 2000 | Supplement 11Labeling | Approved | None posted |
| Apr 7, 1999 | Supplement 10Manufacturing | Approved | None posted |
| Apr 6, 1998 | Supplement 9Manufacturing | Approved | None posted |
| Oct 11, 1996 | Supplement 7Manufacturing | Approved | None posted |
| Jul 24, 1996 | Supplement 5Manufacturing | Approved | None posted |
| Jul 24, 1996 | Supplement 4Manufacturing | Approved | None posted |
| Jul 24, 1996 | Supplement 3Manufacturing | Approved | None posted |
| Jun 28, 1996 | Supplement 8Manufacturing | Approved | None posted |
| Jan 30, 1995 | Supplement 2Manufacturing | Approved | None posted |
| Jan 30, 1995 | Supplement 1Manufacturing | Approved | None posted |
| Nov 19, 1993 | 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
