tocilizumab Injection

Brand(s)
Actemra
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2014-11-19)
Oldest Current Product
2010-01-08
License(s)
BLA
RxNORM
INJECTION\TOCILIZUMAB
SPL Active
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\TOCILIZUMAB
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\TOCILIZUMAB

product(s) by strength(s)

4 ml tocilizumab 20 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502420135ActemraBLAGenentech, Inc.2010-01-08TOCILIZUMABINTRAVENOUSINJECTION, SOLUTION, CONCENTRATE1252762e5365ff-cb2a-4b16-b2c7-e35c6bf2de13

10 ml tocilizumab 20 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502420136ActemraBLAGenentech, Inc.2010-01-08TOCILIZUMABINTRAVENOUSINJECTION, SOLUTION, CONCENTRATE1252762e5365ff-cb2a-4b16-b2c7-e35c6bf2de13

20 ml tocilizumab 20 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502420137ActemraBLAGenentech, Inc.2010-01-08TOCILIZUMABINTRAVENOUSINJECTION, SOLUTION, CONCENTRATE1252762e5365ff-cb2a-4b16-b2c7-e35c6bf2de13

application(s)

#idtitleapprovedtradenamesfda division
1125276tocilizumab Application2010-01-08ActemraCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
12e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 (view SPL)These highlights do not include all the information needed to use ACTEMRA safely and effectively. See full prescribing information for ACTEMRA. ACTEMRA (tocilizumab) injection, for intravenous useinjection, for subcutaneous useInitial U.S. Approval: 2010prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-11-1914502420135, 502420136, 502420137, 502420138tocilizumab Prefilled Syringe

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