cetuximab Injection

Brand(s)
Erbitux
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Imclone Llc (2015-10-05)
Oldest Current Product
2004-02-12
License(s)
BLA
RxNORM
INJECTION\CETUXIMAB
SPL Active
INTRAVENOUS\SOLUTION\CETUXIMAB
SPL Moiety
INTRAVENOUS\SOLUTION\CETUXIMAB

product(s) by strength(s)

50 ml cetuximab 2 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1667330948ErbituxBLAImclone Llc2004-02-12CETUXIMABINTRAVENOUSSOLUTION1250848bc6397e-4bd8-4d37-a007-a327e4da34d9

100 ml cetuximab 2 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1667330958ErbituxBLAImclone Llc2007-10-02CETUXIMABINTRAVENOUSSOLUTION1250848bc6397e-4bd8-4d37-a007-a327e4da34d9

application(s)

#idtitleapprovedtradenamesfda division
1125084cetuximab Application2004-02-12ErbituxCDER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
18bc6397e-4bd8-4d37-a007-a327e4da34d9 (view SPL)These highlights do not include all the information needed to use ERBITUX safely and effectively. See full prescribing information for ERBITUX. ERBITUX (cetuximab)injection, for intravenous infusionInitial U.S. Approval: 2004prescriptionHuman PrescriptionImclone Llc2015-10-0534667330948, 667330958

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