ofatumumab Injection

Brand(s)
Arzerra
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2014-04-17)
Oldest Current Product
2011-07-22
License(s)
BLA
RxNORM
INJECTION\OFATUMUMAB
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\OFATUMUMAB
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\OFATUMUMAB

product(s) by strength(s)

ofatumumab 20 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730821ArzerraBLAGlaxosmithkline Llc2011-07-22OFATUMUMABINTRAVENOUSINJECTION, SOLUTION125326e6e738dc-9026-4cd3-8f85-7b10ac730e7d

application(s)

#idtitleapprovedtradenamesfda division
1125326ofatumumab Application2009-10-26ArzerraCDER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1e6e738dc-9026-4cd3-8f85-7b10ac730e7d (view SPL)These highlights do not include all the information needed to use ARZERRA safely and effectively. See full prescribing information for ARZERRA.ARZERRA (ofatumumab)Injection, for intravenous infusionInitial U.S. Approval: 2009prescriptionHuman PrescriptionGlaxosmithkline Llc2014-04-178001730821

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