NDA 20337, held by Fougera Pharms. Clobetasol Propionate.
As of Nov 13, 2026, NDA 20337 (Temovate), held by Fougera Pharms, was first approved by FDA on Apr 29, 1994, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 1994 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Temovate0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · gel;topical | Clobetasol Propionate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 2, 2003 | Supplement 5Labeling · Standard review | Approved | |
| Jun 5, 1998 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1997 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 15, 1996 | Supplement 1Manufacturing · Standard review | Approved | |
| Apr 29, 1994 | Original applicationNew dosage form · 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
