Product Details for: Remicade
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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(a)
Remicade
Rx
Proper Name
infliximab
infliximab
BLA Number
103772
103772
Applicant
Janssen Biotech, Inc.
Janssen Biotech, Inc.
Original Approval Date
August 24, 1998
August 24, 1998
Date of First Licensure