Treats plaque psoriasis of up to 20% body surface area involvement. ANDA 214136, held by Cosette Pharms Nc. Tazarotene.
As of Nov 15, 2026, ANDA 214136 (Tazarotene), held by Cosette Pharms Nc, was first approved by FDA on Sep 13, 2022, with 0 approved supplements and 0 published complete response letters.
Trilitas gel, 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. Trilitas gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. Limitations of Use The safety of Trilitas gel use on more than 20% body surface area has not been established. 1.1 Plaque Psoriasis Trilitas (tazarotene) gel, 0.1% is indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement. 1.2 Acne Vulgaris Trilitas (tazarotene) gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 13, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tazarotene0.1% · gel;topical | Tazarotene | Rx |
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
