Treats moderate to severe scalp psoriasis in subjects 18 years of age and older. NDA 21644, held by Galderma Labs. Clobetasol Propionate.
As of Nov 14, 2026, NDA 21644 (Clobex), held by Galderma Labs, was first approved by FDA on Feb 5, 2004, with 2 approved supplements and 0 published complete response letters.
Clobetasol Propionate Shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older. Limitations of Use: Do not use on the face, axillae or groin. Avoid any contact with the eyes and lips. 1.1 Indication
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 5, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clobex0.05% · shampoo;topical | Clobetasol Propionate | RxReference drug |
| Nov 30, 2012 | Supplement 3Labeling | Approved | |
| Aug 17, 2012 | Supplement 2Labeling | Approved | |
| Feb 5, 2004 | 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
