Product Details for: Avzivi
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
100MG/4ML (25MG/ML)
Single-Dose Vial
351(k) Biosimilar
Avzivi
Rx
002
Injection
Intravenous
400MG/16ML (25MG/ML)
Single-Dose Vial
351(k) Biosimilar
Avzivi
Rx
Proper Name
bevacizumab-tnjn
bevacizumab-tnjn
Reference Product Proper Name
bevacizumab
bevacizumab
Reference Product Properietary Name
Avastin
Avastin
BLA Number
761198
761198
Applicant
Bio-Thera Solutions, Ltd.
Bio-Thera Solutions, Ltd.
Original Approval Date
December 6, 2023
December 6, 2023
Date of First Licensure