Product Details for: Byooviz

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravitreal
10MG/ML
Single-Dose Vial
351(k) Interchangeable
Byooviz
Rx
Proper Name
ranibizumab-nuna
Reference Product Proper Name
ranibizumab
Reference Product Properietary Name
Lucentis
BLA Number
761202
Applicant
Samsung Bioepis Co., Ltd.
Original Approval Date
September 17, 2021
Date of First Licensure
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