Treats acne vulgaris. ANDA 75589, held by Padagis US. Tretinoin.
As of Nov 15, 2026, ANDA 75589 (Tretinoin), held by Padagis US, was first approved by FDA on Jun 11, 2002, with 2 approved supplements and 0 published complete response letters.
Indications and Usage: Tretinoin gel and cream are 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 |
|---|---|---|---|
| Jun 11, 2002 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tretinoin0.01% · gel;topical | Tretinoin | Rx |
| May 25, 2007 | Supplement 6Labeling | Approved | None posted |
| Feb 21, 2007 | Supplement 4Labeling | Approved | None posted |
| Jun 11, 2002 | Original application | Approved | None posted |
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
