tocilizumab Prefilled Syringe

Brand(s)
Actemra
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2014-11-19)
Oldest Current Product
2013-10-21
License(s)
BLA
RxNORM
PREFILLED SYRINGE\TOCILIZUMAB
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\TOCILIZUMAB
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\TOCILIZUMAB

product(s) by strength(s)

0.9 ml tocilizumab 180 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502420138ActemraBLAGenentech, Inc.2013-10-21TOCILIZUMABSUBCUTANEOUSINJECTION, SOLUTION1254722e5365ff-cb2a-4b16-b2c7-e35c6bf2de13

application(s)

#idtitleapprovedtradenamesfda division
1125472tocilizumab Application2013-10-21ActemraCDER

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, PACK2014-11-1914502420138, 502420135, 502420136, 502420137tocilizumab Injection

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