vedolizumab Injection

Brand(s)
Entyvio
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Takeda Pharmaceuticals America, Inc. (2014-05-22)
Oldest Current Product
2014-05-20
License(s)
BLA
RxNORM
INJECTION\VEDOLIZUMAB
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\VEDOLIZUMAB
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\VEDOLIZUMAB

product(s) by strength(s)

vedolizumab 300 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640300EntyvioBLATakeda Pharmaceuticals America, Inc.2014-05-20VEDOLIZUMABINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION1254766e94621c-1a95-4af9-98d1-52b9e6f1949c

application(s)

#idtitleapprovedtradenamesfda division
1125476vedolizumab Application2014-05-20EntyvioCDER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
16e94621c-1a95-4af9-98d1-52b9e6f1949c (view SPL)These highlights do not include all the information needed to use ENTYVIO safely and effectively. See full prescribing information for ENTYVIO.ENTYVIO (vedolizumab) for injection, for intravenous useInitial U.S. Approval: 2014prescriptionHuman PrescriptionTakeda Pharmaceuticals America, Inc.2014-05-221647640300

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