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XALKORI (nda202570)- (200MG,250MG)

CRIZOTINIB PF PRISM CV
200MG,250MG
No No
2029-Nov-06 2016-Aug-26
2018-Aug-26 None
None No
XALKORI is a kinase inhibitor indicated for the treatment of • adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. • pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. • adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.
0 0 0
Total Other Developers None
Drugs with Suitability No
200MG ** ** - - -
250MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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