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Purple Book
Database of Licensed Biological Products

Product Details for: Simponi Aria
Product Label Grayed out Product Label links indicate that there is no product label available for the product.

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001Injection Intravenous50MG/4ML (12.5MG/ML)Single-Dose Vial351(a)Simponi AriaRx

Proper Name
golimumab

BLA Number
125433

Applicant
Janssen Biotech, Inc.

Original Approval Date
July 18, 2013

Date of First Licensure