trial
Product details Drug product assessment reports API Information Product Details Active Ingredient: CRIZOTINIB Proprietary Name : XALKORI Dosage Form; Route of Administration: CAPSULE; ORAL Strength: 200 MG and 250 MG Reference Listed Drug: 200 MG and 250 MG Reference Standard: 250 MG TE Code: None Application Number: N202570 Approval Date: Aug 26, 2011 Applicant Holder Full Name: PF PRISM CV Marketing Status: Prescription Regulatory status: Approval in different country: US FDA: Aug 26, 2011 EMA: 23 October 2012 Health Canada: May 10, 2012 Australia: 13 December 2017 Note: XALKORI has received approval for patients with ALK-positive NSCLC in more than 90 countries including Australia...