Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206947

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LENVIMA (LENVATINIB MESYLATE)
EQ 4MG BASE
Marketing Status: Prescription

Active Ingredient: LENVATINIB MESYLATE
Proprietary Name: LENVIMA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N206947
Product Number: 001
Approval Date: Feb 13, 2015
Applicant Holder Full Name: EISAI INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LENVIMA (LENVATINIB MESYLATE)
EQ 10MG BASE
Marketing Status: Prescription

Active Ingredient: LENVATINIB MESYLATE
Proprietary Name: LENVIMA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N206947
Product Number: 002
Approval Date: Feb 13, 2015
Applicant Holder Full Name: EISAI INC
Marketing Status:  Prescription
Patent and Exclusivity Information