NDA 22013, held by Quagen. Clobetasol Propionate.
As of Nov 13, 2026, NDA 22013 (Olux E), held by Quagen, was first approved by FDA on Jan 12, 2007, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 12, 2007 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Olux E0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · aerosol, foam;topical | Clobetasol Propionate | DiscontinuedReference drug |
| May 14, 2018 | Supplement 13Labeling · Standard review | Approved | |
| Apr 21, 2016 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Apr 23, 2013 | Supplement 9Labeling · Standard review | Approved | |
| Nov 10, 2010 | Supplement 5Labeling | Approved | |
| Jul 17, 2007 | Supplement 1Manufacturing | Approved | |
| Jan 12, 2007 | Original applicationNew formulation or manufacturer · 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
