NDA 19963, held by Valeant Pharms North. Tretinoin.
As of Nov 13, 2026, NDA 19963 (Renova), held by Valeant Pharms North, was first approved by FDA on Dec 29, 1995, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 1, 2000 | Supplement 5Efficacy (new indication or use) | Approved | |
| Dec 29, 1995 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Renova0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · cream;topical | Tretinoin | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 8, 2013 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Mar 20, 2001 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Aug 1, 2000 | Supplement 7Labeling · Standard review | Approved | |
| Aug 1, 2000 | Supplement 5Efficacy (new indication or use) | Approved | |
| Jan 25, 1999 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 23, 1998 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Feb 20, 1998 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 19, 1996 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 9, 1996 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 29, 1995 | Original applicationNew dosage form · Standard review | 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
