← FDA DRUG APPROVALS

FDA NDA · NDA217581

XALKORI

crizotinib

Sponsor: PF PRISM CV

APPLICATION
NDA217581
TYPE
NDA
ORIGINAL APPROVAL
2023-09-07
LATEST ACTION
2023-09-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE, PELLETS
MARKETING STATUS
Prescription

Products

XALKORI · ReferencePrescription
CRIZOTINIB 50MG · CAPSULE, PELLETS · ORAL
XALKORI · ReferencePrescription
CRIZOTINIB 150MG · CAPSULE, PELLETS · ORAL
XALKORI · ReferencePrescription
CRIZOTINIB 20MG · CAPSULE, PELLETS · ORAL

Approval history

2023-09-07Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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