golimumab Injection

Brand(s)
Simponi
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Biotech, Inc. (2015-08-10)
Oldest Current Product
2013-07-19
License(s)
BLA
RxNORM
INJECTION\GOLIMUMAB
SPL Active
INTRAVENOUS\SOLUTION\GOLIMUMAB
SPL Moiety
INTRAVENOUS\SOLUTION\GOLIMUMAB

product(s) by strength(s)

4 ml golimumab 12.5 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1578940350SimponiBLAJanssen Biotech, Inc.2013-07-19GOLIMUMABINTRAVENOUSSOLUTION1254339e260a47-55af-4c92-8d88-a86ccc767fff

application(s)

#idtitleapprovedtradenamesfda division
1125433golimumab injection, for IV use Application2013-07-18Simponi AriaCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
19e260a47-55af-4c92-8d88-a86ccc767fff (view SPL)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: 2009prescriptionHuman PrescriptionJanssen Biotech, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-08-106578940350

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII