Product Details for: Eticovo

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
50MG/ML
Pre-Filled Syringe
351(k) Interchangeable
Eticovo
Disc
002
Injection
Subcutaneous
25MG/0.5ML
Pre-Filled Syringe
351(k) Interchangeable
Eticovo
Disc
003
Injection
Subcutaneous
50MG/ML
Autoinjector
351(k) Biosimilar
Eticovo
Disc
Proper Name
etanercept-ykro
Reference Product Proper Name
etanercept
Reference Product Properietary Name
Enbrel
BLA Number
761066
Applicant
Samsung Bioepis Co., Ltd.
Original Approval Date
April 25, 2019
Date of First Licensure
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