NDA 21108, held by Valeant Pharms North. Tretinoin.
As of Nov 13, 2026, NDA 21108 (Renova), held by Valeant Pharms North, was first approved by FDA on Aug 31, 2000, with 7 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 2000 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Renova0.02% · cream;topical | Tretinoin | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 25, 2016 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Sep 22, 2014 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jun 13, 2014 | Supplement 15Manufacturing · Standard review | Approved | |
| Jan 8, 2013 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jul 14, 2002 | Supplement 1Labeling · Standard review | Approved | |
| Apr 6, 2001 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 20, 2001 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Aug 31, 2000 | Original applicationNew dosage form · Standard 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
