ANDA 208258, held by Sun Pharma Canada. Tazarotene.
As of Nov 15, 2026, ANDA 208258 (Tazarotene), held by Sun Pharma Canada, was first approved by FDA on Apr 3, 2017, with 0 approved supplements and 0 published complete response letters.
Tazarotene cream, 0.1% is indicated as an adjunctive agent for use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper-and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 3, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tazarotene0.1% · cream;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
