Product Details for: Renflexis

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
100MG
Single-Dose Vial
351(k) Biosimilar
Renflexis
Rx
Proper Name
infliximab-abda
Reference Product Proper Name
infliximab
Reference Product Properietary Name
Remicade
BLA Number
761054
Applicant
Samsung Bioepis Co., Ltd.
Original Approval Date
April 21, 2017
Date of First Licensure
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