Product Details for: Inflectra

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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
Inflectra
Rx
Proper Name
infliximab-dyyb
Reference Product Proper Name
infliximab
Reference Product Properietary Name
Remicade
BLA Number
125544
Applicant
CELLTRION, Inc.
Original Approval Date
April 5, 2016
Date of First Licensure
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