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Purple Book
Database of Licensed Biological Products

Product Details for: Simponi
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 Subcutaneous50MG/0.5MLAutoinjector351(a)SimponiRx
002Injection Subcutaneous50MG/0.5MLPre-Filled Syringe351(a)SimponiRx
003Injection Subcutaneous100MG/MLAutoinjector351(a)SimponiRx
004Injection Subcutaneous100MG/MLPre-Filled Syringe351(a)SimponiRx

Proper Name
golimumab

BLA Number
125289

Applicant
Janssen Biotech, Inc.

Original Approval Date
April 24, 2009

Date of First Licensure