Treats plaque psoriasis. NDA 208183, held by Lacer Pharma. Halobetasol Propionate.
As of Nov 14, 2026, NDA 208183 (Ultravate), held by Lacer Pharma, was first approved by FDA on Nov 6, 2015, with 1 approved supplement and 0 published complete response letters.
Halobetasol Propionate Lotion 0.05% is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.
| Aug 27, 2020 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Nov 6, 2015 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ultravate0.05% · lotion;topical | Halobetasol Propionate | RxReference drug |
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
