Treats acne vulgaris. ANDA 75213, held by Padagis US. Tretinoin.
As of Nov 15, 2026, ANDA 75213 (Tretinoin), held by Padagis US, was first approved by FDA on Dec 24, 1998, with 12 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 |
|---|---|---|---|
| Dec 24, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tretinoin0.1% · cream;topical | Tretinoin | Rx |
| Apr 20, 2007 | Supplement 26Labeling | Approved | None posted |
| Feb 21, 2007 | Supplement 24Labeling | Approved | None posted |
| Oct 24, 2001 | Supplement 15Manufacturing | Approved | None posted |
| Oct 24, 2001 | Supplement 14Manufacturing | Approved | None posted |
| Oct 24, 2001 | Supplement 13Manufacturing | Approved | None posted |
| Jan 23, 2001 | Supplement 12Manufacturing | Approved | None posted |
| Jan 23, 2001 | Supplement 7Manufacturing | Approved | None posted |
| Jan 23, 2001 | Supplement 6Manufacturing | Approved | None posted |
| Aug 1, 2000 | Supplement 9Manufacturing | Approved | None posted |
| Aug 1, 2000 | Supplement 8Manufacturing | Approved | None posted |
| Feb 29, 2000 | Supplement 5Manufacturing | Approved | None posted |
| Dec 23, 1999 | Supplement 3Manufacturing | Approved | None posted |
| Dec 24, 1998 | Original application | Approved |
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
