alirocumab Prefilled Syringe

Brand(s)
Praluent
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2015-07-24)
Oldest Current Product
2015-07-24
License(s)
BLA
RxNORM
PREFILLED SYRINGE\ALIROCUMAB
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\ALIROCUMAB
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\ALIROCUMAB

product(s) by strength(s)

1 ml alirocumab 150 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000245904PraluentBLASanofi-Aventis U.S. Llc2015-07-24ALIROCUMABSUBCUTANEOUSINJECTION, SOLUTION125559446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4

1 ml alirocumab 75 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000245903PraluentBLASanofi-Aventis U.S. Llc2015-07-24ALIROCUMABSUBCUTANEOUSINJECTION, SOLUTION125559446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4

application(s)

#idtitleapprovedtradenamesfda division
1125559alirocumab Application2015-07-24PraluentCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4 (view SPL)These highlights do not include all the information needed to use PRALUENT safely and effectively. See full prescribing information for PRALUENT. PRALUENT (alirocumab) injection, for subcutaneous useInitial U.S. Approval: 2015prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-07-241000245903, 000245904, 000245901, 000245902alirocumab Auto-Injector

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