SIMPONI ARIA
These highlights do not include all the information needed to use SIMPONI ARIA safely and effectively. See full prescribing information for SIMPONI ARIA. SIMPONI ARIA (golimumab) injection, for intravenous use Initial U.S. Approval: 2009
Approved
Approval ID
9e260a47-55af-4c92-8d88-a86ccc767fff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 19, 2023
Manufacturers
FDA
Janssen Biotech, Inc.
DUNS: 099091753
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
golimumab
PRODUCT DETAILS
NDC Product Code57894-350
Application NumberBLA125433
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateJuly 19, 2023
Generic Namegolimumab
INGREDIENTS (6)
SORBITOLInactive
Quantity: 180 mg in 4 mL
Code: 506T60A25R
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 6.42 mg in 4 mL
Code: X573657P6P
Classification: IACT
HISTIDINEInactive
Quantity: 1.14 mg in 4 mL
Code: 4QD397987E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GOLIMUMABActive
Quantity: 50 mg in 4 mL
Code: 91X1KLU43E
Classification: ACTIB
POLYSORBATE 80Inactive
Quantity: 0.6 mg in 4 mL
Code: 6OZP39ZG8H
Classification: IACT