NDA 21142, held by Quagen. Clobetasol Propionate.
As of Nov 14, 2026, NDA 21142 (Olux), held by Quagen, was first approved by FDA on May 26, 2000, with 13 approved supplements and 0 published complete response letters.
| Dec 20, 2002 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| May 26, 2000 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Olux0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · aerosol, foam;topical | Clobetasol Propionate | DiscontinuedReference drug |
| Apr 25, 2018 | Supplement 22Labeling · Standard review | Approved | |
| Apr 23, 2014 | Supplement 19Labeling · Standard review | Approved | |
| Jun 7, 2013 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jul 11, 2006 | Supplement 12Labeling · Standard review | Approved | |
| Dec 29, 2003 | Supplement 10Manufacturing · Standard review | Approved | |
| Oct 31, 2003 | Supplement 9Labeling · Standard review | Approved | |
| Jul 21, 2003 | Supplement 7Manufacturing · Standard review | Approved | |
| Dec 20, 2002 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Sep 17, 2002 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Aug 21, 2002 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Mar 13, 2002 | Supplement 3Manufacturing · Standard review | Approved | |
| Nov 29, 2001 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Sep 14, 2000 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| May 26, 2000 | Original applicationNew dosage form · Standard review | Approved |
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
