evolocumab Prefilled Syringe

Brand(s)
Repatha
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amgen Inc (2015-09-23)
Oldest Current Product
2015-08-31
License(s)
BLA
RxNORM
PREFILLED SYRINGE\EVOLOCUMAB
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\EVOLOCUMAB
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\EVOLOCUMAB

product(s) by strength(s)

1 ml evolocumab 140 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555130750RepathaBLAAmgen Inc2015-08-31EVOLOCUMABSUBCUTANEOUSINJECTION, SOLUTION125522709338ae-ab8f-44a9-b7d5-abaabec3493a

application(s)

#idtitleapprovedtradenamesfda division
1125522evolocumab Application2015-08-27RepathaCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1709338ae-ab8f-44a9-b7d5-abaabec3493a (view SPL)These highlights do not include all the information needed to use REPATHA safely and effectively. See full prescribing information for REPATHA . REPATHA (evolocumab) injection, for subcutaneous use Initial U.S. Approval: 2015prescriptionHuman PrescriptionAmgen IncANALYSIS, LABEL, MANUFACTURE, PACK2015-09-236555130750, 555130760evolocumab Auto-Injector

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