peginterferon alfa-2a Injection

Brand(s)
Pegasys
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2015-07-27)
Oldest Current Product
2002-10-16
License(s)
BLA
RxNORM
INJECTION\PEGINTERFERON ALFA-2A
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\PEGINTERFERON ALFA-2A
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\PEGINTERFERON ALFA-2A

product(s) by strength(s)

1 ml peginterferon alfa-2a 0.18 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000040350PegasysBLAGenentech, Inc.2002-10-16PEGINTERFERON ALFA-2ASUBCUTANEOUSINJECTION, SOLUTION103964de61685e-2b8c-4e22-84bb-869e13600440

application(s)

#idtitleapprovedtradenamesfda division
1103964peginterferon alfa-2a Application2002-10-16PegasysCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1de61685e-2b8c-4e22-84bb-869e13600440 (view SPL)These highlights do not include all the information needed to use PEGASYS safely and effectively. See full prescribing information for PEGASYS. PEGASYS (peginterferon alfa-2a) injection, for subcutaneous use Initial U.S. Approval: 2002prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-07-2726000040350, 000040352, 000040357, 000040360, 000040365peginterferon alfa-2a Prefilled Syringe
peginterferon alfa-2a Auto-Injector

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