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SPRYCEL (nda021986)- (20MG,50MG,70MG,80MG,100MG,140MG)

DASATINIB BRISTOL MYERS SQUIBB
20MG,50MG,70MG,80MG,100MG,140MG
Yes No
2026-Sep-28 2011-Jun-28
2013-Jun-28 None
None No
SPRYCEL is a kinase inhibitor indicated for the treatment of • newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. • adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. • adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. • pediatric patients 1 year of age and older with Ph+ CML in chronic phase. • pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.
2 5 2
Total Other Developers 39
Drugs with Suitability No
20MG ** ** - - -
50MG ** ** - - -
70MG ** ** - - -
80MG ** ** - - -
100MG ** ** Up - -
140MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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