Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217581

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XALKORI (CRIZOTINIB)
20MG
Marketing Status: Prescription

Active Ingredient: CRIZOTINIB
Proprietary Name: XALKORI
Dosage Form; Route of Administration: CAPSULE, PELLETS; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N217581
Product Number: 001
Approval Date: Sep 7, 2023
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information

XALKORI (CRIZOTINIB)
50MG
Marketing Status: Prescription

Active Ingredient: CRIZOTINIB
Proprietary Name: XALKORI
Dosage Form; Route of Administration: CAPSULE, PELLETS; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N217581
Product Number: 002
Approval Date: Sep 7, 2023
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information

XALKORI (CRIZOTINIB)
150MG
Marketing Status: Prescription

Active Ingredient: CRIZOTINIB
Proprietary Name: XALKORI
Dosage Form; Route of Administration: CAPSULE, PELLETS; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217581
Product Number: 003
Approval Date: Sep 7, 2023
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information