Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022405

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CAPRELSA (VANDETANIB)
100MG Marketing Status: Prescription

Active Ingredient: VANDETANIB
Proprietary Name: CAPRELSA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022405
Product Number: 001
Approval Date: Apr 6, 2011
Applicant Holder Full Name: GENZYME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

CAPRELSA (VANDETANIB)
300MG Marketing Status: Prescription

Active Ingredient: VANDETANIB
Proprietary Name: CAPRELSA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022405
Product Number: 002
Approval Date: Apr 6, 2011
Applicant Holder Full Name: GENZYME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

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