Treats plaque psoriasis of up to 20% body surface area involvement. ANDA 213644, held by Solaris Pharma Corp. Tazarotene.
As of Nov 15, 2026, ANDA 213644 (Tazarotene), held by Solaris Pharma Corp, was first approved by FDA on Mar 20, 2023, with 0 approved supplements and 0 published complete response letters.
Tazarotene gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. Tazarotene gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. Limitations of Use The safety of tazarotene gel use on more than 20% body surface area has not been established. 1.1 Plaque Psoriasis Tazarotene gel, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement. 1.2 Acne Vulgaris 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 |
|---|---|---|---|
| Mar 20, 2023 | Original application | Approved | None posted |
| Tazarotene0.05% · gel;topical | Tazarotene | Rx |
| 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
