Product Details for: Simponi Aria
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
50MG/4ML (12.5MG/ML)
Single-Dose Vial
351(a)
Simponi Aria
Rx
Proper Name
golimumab
golimumab
BLA Number
125433
125433
Applicant
Janssen Biotech, Inc.
Janssen Biotech, Inc.
Original Approval Date
July 18, 2013
July 18, 2013
Date of First Licensure