Product Details for: Avsola
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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
Avsola
Rx
Proper Name
infliximab-axxq
infliximab-axxq
Reference Product Proper Name
infliximab
infliximab
Reference Product Properietary Name
Remicade
Remicade
BLA Number
761086
761086
Applicant
Amgen Inc.
Amgen Inc.
Original Approval Date
December 6, 2019
December 6, 2019
Date of First Licensure