Treats acne vulgaris. ANDA 211644, held by Sun Pharma Canada. Tretinoin.
As of Nov 15, 2026, ANDA 211644 (Tretinoin), held by Sun Pharma Canada, was first approved by FDA on Jan 25, 2019, with 0 approved supplements and 0 published complete response letters.
Indications and Usage Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 25, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tretinoin0.05% · cream;topical | Tretinoin | 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
