Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 022405

Expand all

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