Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202570

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XALKORI (CRIZOTINIB)
200MG
Marketing Status: Prescription

Active Ingredient: CRIZOTINIB
Proprietary Name: XALKORI
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202570
Product Number: 001
Approval Date: Aug 26, 2011
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information

XALKORI (CRIZOTINIB)
250MG
Marketing Status: Prescription

Active Ingredient: CRIZOTINIB
Proprietary Name: XALKORI
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 250MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202570
Product Number: 002
Approval Date: Aug 26, 2011
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information