NDA 18182, held by Bayer Healthcare LLC. Clotrimazole.
As of Nov 13, 2026, NDA 18182 (Mycelex-7), held by Bayer Healthcare LLC, was first approved by FDA on Feb 27, 1979, with 11 approved supplements and 0 published complete response letters.
| Dec 26, 1991 | Supplement 9Efficacy (new indication or use) | Approved | None posted |
| Feb 27, 1979 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycelex-7100MG · tablet;vaginal | Clotrimazole | Discontinued |
| Sep 7, 2001 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Feb 10, 2000 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| May 24, 1993 | Supplement 12Labeling · Standard review | Approved | None posted |
| Feb 22, 1993 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Oct 8, 1992 | Supplement 11Labeling | Approved | None posted |
| Dec 26, 1991 | Supplement 9Efficacy (new indication or use) | Approved | None posted |
| Nov 15, 1990 | Supplement 8Labeling | Approved | None posted |
| Jun 3, 1987 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1982 | Supplement 5Labeling | Approved | None posted |
| Jan 9, 1981 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 5, 1980 | Supplement 1Labeling | Approved | None posted |
| Feb 27, 1979 | Original applicationNew formulation or manufacturer · Standard review | 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
