omalizumab Injection

Brand(s)
Xolair
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2014-10-06)
Oldest Current Product
2003-06-20
License(s)
BLA
RxNORM
INJECTION\OMALIZUMAB
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\OMALIZUMAB
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\OMALIZUMAB

product(s) by strength(s)

omalizumab 150 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502420040XolairBLAGenentech, Inc.2003-06-20OMALIZUMABSUBCUTANEOUSINJECTION, SOLUTION1039767f6a2191-adfb-48b9-9bfa-0d9920479f0d

application(s)

#idtitleapprovedtradenamesfda division
1103976omalizumab Application2003-06-20XolairCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
17f6a2191-adfb-48b9-9bfa-0d9920479f0d (view SPL)These highlights do not include all the information needed to use XOLAIR safely and effectively. See full prescribing information for XOLAIR. XOLAIR (omalizumab) for injection, for subcutaneous useInitial U.S. Approval: 2003prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-10-065502420040

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