natalizumab Injection

Brand(s)
Tysabri
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Elan Pharmaceuticals, Inc. (2012-12-21)
Oldest Current Product
2004-11-23
License(s)
BLA
RxNORM
INJECTION\NATALIZUMAB
SPL Active
INTRAVENOUS\INJECTION\NATALIZUMAB
SPL Moiety
INTRAVENOUS\INJECTION\NATALIZUMAB

product(s) by strength(s)

15 ml natalizumab 20 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1590750730TysabriBLAElan Pharmaceuticals, Inc.2004-11-232016-06-30NATALIZUMABINTRAVENOUSINJECTION1251046fa00cb8-4229-4770-9d2a-d4a8542b3180

application(s)

#idtitleapprovedtradenamesfda division
1125104natalizumab Application2004-11-23TysabriCDER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
16fa00cb8-4229-4770-9d2a-d4a8542b3180 (view SPL)These highlights do not include all the information needed to use TYSABRI safely and effectively. See full prescribing information for TYSABRI.TYSABRI (natalizumab) injection, for intravenous useInitial U.S. Approval: 2004prescriptionHuman PrescriptionElan Pharmaceuticals, Inc.2012-12-2126590750730
2c5fdde91-1989-4dd2-9129-4f3323ea2962 (view SPL)These highlights do not include all the information needed to use TYSABRI safely and effectively. See full prescribing information for TYSABRI.TYSABRI (natalizumab) injection, for intravenous useInitial U.S. Approval: 2004prescriptionHuman PrescriptionBiogen Idec Inc.2015-05-1422644060008

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