Treats cutaneous lesions. NDA 21056, held by Bausch. Bexarotene.
As of Nov 14, 2026, NDA 21056 (Targretin), held by Bausch, was first approved by FDA on Jun 28, 2000, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Targretin (bexarotene) gel 1% is indicated for the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 28, 2000 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Targretin1% · gel;topical | Bexarotene | RxReference drug |
| Feb 9, 2015 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Jul 22, 2013 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Apr 8, 2011 | Supplement 3Labeling · Standard review | Approved | |
| Mar 14, 2002 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Jun 28, 2000 | Original applicationNew dosage form · Priority review | 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
