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JAKAFI (nda202192)- (EQ 5MG BASE,EQ 10MG BASE,EQ 15MG BASE,EQ 20MG BASE,EQ 25MG BASE)

RUXOLITINIB PHOSPHATE INCYTE CORP
EQ 5MG BASE,EQ 10MG BASE,EQ 15MG BASE,EQ 20MG BASE,EQ 25MG BASE
Yes No
2028-Dec-12 2016-Nov-16
2018-Nov-16 None
None No
Jakafi is a kinase inhibitor indicated for treatment of: • intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults. • polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. • steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. • chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
0 0 0
Total Other Developers 14
Drugs with Suitability No
EQ 5MG BASE ** ** - - -
EQ 10MG BASE ** ** - - -
EQ 15MG BASE ** ** - - -
EQ 20MG BASE ** ** - - -
EQ 25MG BASE ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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