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Treats plaque psoriasis of up to 20% body surface area involvement. ANDA 213079, held by Padagis Israel. Tazarotene.
As of Nov 15, 2026, ANDA 213079 (Tazarotene), held by Padagis Israel, was first approved by FDA on Apr 25, 2023, with 0 approved supplements and 0 published complete response letters.
First approved: Apr 25, 2023
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
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.
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
