Treats plaque psoriasis. NDA 209354, held by Bausch. Halobetasol Propionate; Tazarotene.
As of Nov 14, 2026, NDA 209354 (Duobrii), held by Bausch, was first approved by FDA on Apr 25, 2019, with 0 approved supplements and 1 published complete response letter.
DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is indicated for the topical treatment of plaque psoriasis in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 25, 2019 | Original applicationNew combination · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jun 15, 2018 | Halobetasol propionate and tazarotene lotionNonclinical | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Duobrii0.01%;0.045% · lotion;topical | Halobetasol Propionate; Tazarotene | 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
