obinutuzumab Injection

Brand(s)
Gazyva
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2015-09-30)
Oldest Current Product
2013-11-01
License(s)
BLA
RxNORM
INJECTION\OBINUTUZUMAB
SPL Active
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\OBINUTUZUMAB
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\OBINUTUZUMAB

product(s) by strength(s)

40 ml obinutuzumab 25 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502420070GazyvaBLAGenentech, Inc.2013-11-01OBINUTUZUMABINTRAVENOUSINJECTION, SOLUTION, CONCENTRATE125486df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda

application(s)

#idtitleapprovedtradenamesfda division
1125486obinutuzumab Application2013-11-01GazyvaCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda (view SPL)These highlights do not include all the information needed to use GAZYVA safely and effectively. See full prescribing information for GAZYVA. GAZYVA (obinutuzumab) injection, for intravenous infusion Initial U.S. Approval: 2013prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-09-307502420070

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