ERBITUX (cetuximab) BLA 125084

by IMCLONE

attributevalue
Drug NameERBITUX
Application Number125084
Active Ingredient(s)CETUXIMAB
CompanyIMCLONE
Dosages/Routes/Forms
Drug NameActive Ingredient(s)StrengthForm/RouteMarketing StatusRLDTE Code
ERBITUXCETUXIMAB100mg/VIALVIAL; INTRAVENOUS10
Approval History
DateSupplement No.ActionDocuments
Mar 04, 2013242Labeling Revision
Jul 06, 2012225Supplement
Jan 24, 2012228Supplement
Jan 19, 2012229Supplement
Oct 02, 2007103Supplement
Nov 07, 2011153Supplement
Sep 01, 20050030Supplement
Jul 22, 20090167Supplement
Jul 17, 2009168Supplement
Sep 12, 2008139Supplement
Mar 01, 20060076Supplement
Mar 01, 20060046Supplement
Feb 12, 2004000Approval
Jun 18, 20040001Supplement