Application Nr Approved Date Route Status External Links
NDA021986 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Sprycel (Dasatinib) Is Indicated For The Treatment Of Adult Patients With • Newly Diagnosed Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia (Cml) In Chronic Phase. • Chronic, Accelerated, Or Myeloid Or Lymphoid Blast Phase Ph+ Cml With Resistance Or Intolerance To Prior Therapy Including Imatinib. • Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ All) With Resistance Or Intolerance To Prior Therapy. Sprycel (Dasatinib) Is Indicated For The Treatment Of Pediatric Patients 1 Year Of Age And Older With • Ph+ Cml In Chronic Phase. • Newly Diagnosed Ph+ All In Combination With Chemotherapy. 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. (1 , 14) • Adults With Chronic, Accelerated, Or Myeloid Or Lymphoid Blast Phase Ph+ Cml With Resistance Or Intolerance To Prior Therapy Including Imatinib. (1 , 14) • Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ All) With Resistance Or Intolerance To Prior Therapy. (1 , 14) • Pediatric Patients 1 Year Of Age And Older With Ph+ Cml In Chronic Phase. (1 , 14) • Pediatric Patients 1 Year Of Age And Older With Newly Diagnosed Ph+ All In Combination With Chemotherapy. (1 , 14)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Dasatinib DASATINIB ZINC3986735

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