NDA 20438, held by Cheplapharm. Tretinoin.
As of Nov 14, 2026, NDA 20438 (Vesanoid), held by Cheplapharm, was first approved by FDA on Nov 22, 1995, with 6 approved supplements and 0 published complete response letters.
| Feb 21, 2023 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Nov 22, 1995 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vesanoid10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Tretinoin | DiscontinuedReference drug |
| Oct 4, 2024 | Supplement 9Labeling · Standard review | Approved | |
| Feb 21, 2023 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Feb 21, 2023 | Supplement 7Labeling · Standard review | Approved | |
| Jul 1, 2008 | Supplement 6Labeling · Standard review | Approved | |
| Oct 5, 2004 | Supplement 4Labeling · Standard review | Approved | |
| Feb 14, 2000 | Supplement 1Labeling · Standard review | Approved | |
| Nov 22, 1995 | Original applicationNew dosage form · Priority 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
