Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212904

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FOTIVDA (TIVOZANIB HYDROCHLORIDE)
EQ 0.89MG BASE
Marketing Status: Prescription

Active Ingredient: TIVOZANIB HYDROCHLORIDE
Proprietary Name: FOTIVDA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 0.89MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212904
Product Number: 001
Approval Date: Mar 10, 2021
Applicant Holder Full Name: AVEO PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FOTIVDA (TIVOZANIB HYDROCHLORIDE)
EQ 1.34MG BASE
Marketing Status: Prescription

Active Ingredient: TIVOZANIB HYDROCHLORIDE
Proprietary Name: FOTIVDA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 1.34MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212904
Product Number: 002
Approval Date: Mar 10, 2021
Applicant Holder Full Name: AVEO PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information