rituximab Injection

Brand(s)
Rituxan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2015-10-14)
Oldest Current Product
1997-11-26
License(s)
BLA
RxNORM
INJECTION\RITUXIMAB
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\RITUXIMAB
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\RITUXIMAB

product(s) by strength(s)

50 ml rituximab 10 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502420053RituxanBLAGenentech, Inc.1997-11-26RITUXIMABINTRAVENOUSINJECTION, SOLUTION103705b172773b-3905-4a1c-ad95-bab4b6126563

10 ml rituximab 10 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502420051RituxanBLAGenentech, Inc.1997-11-26RITUXIMABINTRAVENOUSINJECTION, SOLUTION103705b172773b-3905-4a1c-ad95-bab4b6126563

application(s)

#idtitleapprovedtradenamesfda division
1103705rituximab Application1997-11-26RituxanCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1b172773b-3905-4a1c-ad95-bab4b6126563 (view SPL)These highlights do not include all the information needed to use RITUXAN safely and effectively. See full prescribing information for RITUXAN. RITUXAN (rituximab) injection, for intravenous use Initial U.S. Approval: 1997prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-10-1414502420051, 502420053

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