NDA 21790, held by Otsuka. Decitabine.
As of Nov 14, 2026, NDA 21790 (Dacogen), held by Otsuka, was first approved by FDA on May 2, 2006, with 9 approved supplements and 0 published complete response letters.
| Mar 11, 2010 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| May 2, 2006 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dacogen50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intravenous | Decitabine | DiscontinuedReference drug |
| Jun 29, 2020 | Supplement 25Labeling · Standard review | Approved | |
| Feb 25, 2020 | Supplement 23Labeling · Standard review | Approved | |
| Dec 21, 2018 | Supplement 21Labeling · Standard review | Approved | |
| Dec 11, 2018 | Supplement 20Labeling · Standard review | Approved | |
| Mar 8, 2016 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Apr 7, 2015 | Supplement 18Manufacturing · Standard review | Approved | |
| Jan 15, 2014 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| May 6, 2013 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Mar 11, 2010 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| May 2, 2006 | Original applicationNew molecular entity · 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
