Treats myelodysplastic syndromes (MDS) including previously treated and untreated, de…. NDA 205582, held by Sun Pharm. Decitabine.
As of Nov 13, 2026, NDA 205582 (Decitabine), held by Sun Pharm, was first approved by FDA on Jan 23, 2014, with 6 approved supplements and 0 published complete response letters.
Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 23, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Decitabine50MG/VIAL · powder;intravenous | Decitabine | DiscontinuedReference drug |
| Sep 16, 2020 | Supplement 15Labeling · Standard review | Approved | |
| May 21, 2020 | Supplement 14Labeling · Standard review | Approved | |
| Feb 3, 2020 | Supplement 12Labeling · Standard review | Approved | |
| May 22, 2019 | Supplement 9Labeling · Standard review | Approved | |
| Mar 16, 2016 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Aug 14, 2014 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jan 23, 2014 | Original applicationNew formulation or manufacturer · 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
