Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202324

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INLYTA (AXITINIB)
1MG
Marketing Status: Prescription

Active Ingredient: AXITINIB
Proprietary Name: INLYTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202324
Product Number: 001
Approval Date: Jan 27, 2012
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information

INLYTA (AXITINIB)
5MG
Marketing Status: Prescription

Active Ingredient: AXITINIB
Proprietary Name: INLYTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202324
Product Number: 002
Approval Date: Jan 27, 2012
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information