Treats acne vulgaris. NDA 211882, held by Bausch. Tazarotene.
As of Nov 13, 2026, NDA 211882 (Arazlo), held by Bausch, was first approved by FDA on Dec 18, 2019, with 0 approved supplements and 0 published complete response letters.
ARAZLO (tazarotene) lotion, 0.045% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 18, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Arazlo0.045% · lotion;topical | 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
