albiglutide Pen Injector

Brand(s)
Tanzeum
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2015-05-07)
Oldest Current Product
2014-04-15
License(s)
BLA
RxNORM
PEN INJECTOR\ALBIGLUTIDE
SPL Active
SUBCUTANEOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ALBIGLUTIDE
SPL Moiety
SUBCUTANEOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ALBIGLUTIDE

product(s) by strength(s)

0.5 ml albiglutide 100 mg/ml pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730867TanzeumBLAGlaxosmithkline Llc2014-04-15ALBIGLUTIDESUBCUTANEOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION1254315fcad939-76e7-49cf-af94-4e6aef17901f

0.5 ml albiglutide 60 mg/ml pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730866TanzeumBLAGlaxosmithkline Llc2014-04-15ALBIGLUTIDESUBCUTANEOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION1254315fcad939-76e7-49cf-af94-4e6aef17901f

application(s)

#idtitleapprovedtradenamesfda division
1125431albiglutide Application2014-04-15TanzeumCDER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
15fcad939-76e7-49cf-af94-4e6aef17901f (view SPL)These highlights do not include all the information needed to use TANZEUM safely and effectively. See full prescribing information for TANZEUM.TANZEUM (albiglutide) for injection, for subcutaneous useInitial U.S. Approval: 2014prescriptionHuman PrescriptionGlaxosmithkline Llc2015-05-0710001730866, 001730867

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