Product Details for: Opuviz
RETURN TO SEARCH RESULTS
PRODUCT LABEL
Grayed out Product Label links indicate that there is no product label available for the product.
Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravitreal
2MG/0.05ML
Single-Dose Vial
351(k) Interchangeable
Opuviz
Rx
Proper Name
aflibercept-yszy
aflibercept-yszy
Reference Product Proper Name
aflibercept
aflibercept
Reference Product Properietary Name
Eylea
Eylea
BLA Number
761350
761350
Applicant
Samsung Bioepis Co., Ltd.
Samsung Bioepis Co., Ltd.
Original Approval Date
May 20, 2024
May 20, 2024
Date of First Licensure