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DACOGEN (nda021790)- (50MG/VIAL)

DECITABINE OTSUKA
50MG/VIAL
No Yes
Expired 2011-May-02
2013-May-02 None
None No
DACOGEN is a nucleoside metabolic inhibitor 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.
18 0 16
Total Other Developers 9
Drugs with Suitability No
50MG/VIAL ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 13
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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