Treats acne vulgaris. NDA 216632, held by Bausch. Adapalene; Benzoyl Peroxide; Clindamycin Phosphate.
As of Nov 14, 2026, NDA 216632 (Cabtreo), held by Bausch, was first approved by FDA on Oct 20, 2023, with 0 approved supplements and 0 published complete response letters.
CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 20, 2023 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cabtreo0.15%;3.1%;1.2% · gel;topical | Adapalene; Benzoyl Peroxide; Clindamycin Phosphate | 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
