denosumab Injection

Brand(s)
Xgeva
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amgen Inc (2015-06-22)
Oldest Current Product
2010-11-18
License(s)
BLA
RxNORM
INJECTION\DENOSUMAB
SPL Active
SUBCUTANEOUS\INJECTION\DENOSUMAB
SPL Moiety
SUBCUTANEOUS\INJECTION\DENOSUMAB

product(s) by strength(s)

1.7 ml denosumab 70 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555130730XgevaBLAAmgen Inc2010-11-18DENOSUMABSUBCUTANEOUSINJECTION125320628f0998-1206-4001-aeee-18133aa9f3bf

application(s)

#idtitleapprovedtradenamesfda division
1125320denosumab Application2010-06-01Prolia, XgevaCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1628f0998-1206-4001-aeee-18133aa9f3bf (view SPL)These highlights do not include all the information needed to use X GEVA safely and effectively. See full prescribing information for X GEVA . Xgeva ( denosumab ) i njection , for subcutaneous u se Initial U.S. Approval: 2010prescriptionHuman PrescriptionAmgen IncANALYSIS, MANUFACTURE2015-06-22147555130730

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