infliximab Injection

Brand(s)
Remicade
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Biotech, Inc. (2015-10-13)
Oldest Current Product
1998-08-24
License(s)
BLA
RxNORM
INJECTION\INFLIXIMAB
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\INFLIXIMAB
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\INFLIXIMAB

product(s) by strength(s)

infliximab 100 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1578940030RemicadeBLAJanssen Biotech, Inc.1998-08-24INFLIXIMABINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION103772a0a046c1-056d-45a9-bfd9-13b47c24f257

application(s)

#idtitleapprovedtradenamesfda division
1103772infliximab Application1998-08-24RemicadeCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a0a046c1-056d-45a9-bfd9-13b47c24f257 (view SPL)These highlights do not include all the information needed to use REMICADE safely and effectively. See full prescribing information for REMICADE. REMICADE (infliximab) Lyophilized Concentrate for Injection, for Intravenous UseInitial U.S. Approval: 1998prescriptionHuman PrescriptionJanssen Biotech, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2015-10-1321578940030

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