siltuximab Injection

Brand(s)
Sylvant
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Biotech, Inc. (2015-05-04)
Oldest Current Product
2014-04-01
License(s)
BLA
RxNORM
INJECTION\SILTUXIMAB
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\SILTUXIMAB
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\SILTUXIMAB

product(s) by strength(s)

siltuximab 100 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1578940420SylvantBLAJanssen Biotech, Inc.2014-04-23SILTUXIMABINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION125496451f535b-8b6b-4ecf-9f19-d921b72eea39

siltuximab 400 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1578940421SylvantBLAJanssen Biotech, Inc.2014-04-01SILTUXIMABINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION125496451f535b-8b6b-4ecf-9f19-d921b72eea39

application(s)

#idtitleapprovedtradenamesfda division
1125496siltuximab Application2014-04-23SylvantCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1451f535b-8b6b-4ecf-9f19-d921b72eea39 (view SPL)These highlights do not include all the information needed to use SYLVANT safely and effectively. See full prescribing information for SYLVANT. SYLVANT (siltuximab) for Injection, for Intravenous InfusionInitial U.S. Approval: [2014]prescriptionHuman PrescriptionJanssen Biotech, Inc.API MANUFACTURE, MANUFACTURE2015-05-044578940420, 578940421

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