Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125084
Company: IMCLONE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ERBITUX CETUXIMAB 100mg/VIAL VIAL; INTRAVENOUS Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/12/2004 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125084ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2004/125084_erbitux_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/11/2016 SUPPL-265 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125084s265lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125084Orig1s265ltr.pdf
03/11/2015 SUPPL-263 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125084s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125084Orig1s263ltr.pdf
04/10/2015 SUPPL-262 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125084s262lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125084Orig1s262ltr.pdf
03/04/2013 SUPPL-242 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125084s242lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125084Orig1s242ltr.pdf
01/19/2012 SUPPL-229 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s229lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125084s229ltr.pdf
01/24/2012 SUPPL-228 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s0228lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125084s228ltr.pdf
07/06/2012 SUPPL-225 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s225lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125084s225ltr.pdf
03/24/2011 SUPPL-203 Supplement

Label is not available on this site.

07/08/2010 SUPPL-193 Supplement

Label is not available on this site.

07/17/2009 SUPPL-168 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125084s168lbl.pdf
07/17/2009 SUPPL-167 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125084s167lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125084s0167ltr.pdf
11/07/2011 SUPPL-153 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125084s153lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125084s153ltr.pdf
09/12/2008 SUPPL-139 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125084s139ltr.pdf
11/20/2007 SUPPL-112 Supplement

Label is not available on this site.

10/02/2007 SUPPL-103 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125084s103lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125084s103ltl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2007/125084Orig1s103.pdf
03/01/2006 SUPPL-76 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125084s046LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125084s046, 125084s076, 125084s077LTR.pdf
03/01/2006 SUPPL-46 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125084s046LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125084s046LTR.pdf
09/01/2005 SUPPL-30 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125084_0030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125084_0030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/0125084_s030_erbitux.pdf
06/18/2004 SUPPL-1 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125084-0001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/11/2016 SUPPL-265 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125084s265lbl.pdf
04/10/2015 SUPPL-262 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125084s262lbl.pdf
03/11/2015 SUPPL-263 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125084s063lbl.pdf
03/04/2013 SUPPL-242 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125084s242lbl.pdf
07/06/2012 SUPPL-225 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s225lbl.pdf
01/24/2012 SUPPL-228 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s0228lbl.pdf
01/19/2012 SUPPL-229 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s229lbl.pdf
11/07/2011 SUPPL-153 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125084s153lbl.pdf
07/17/2009 SUPPL-168 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125084s168lbl.pdf
07/17/2009 SUPPL-167 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125084s167lbl.pdf
10/02/2007 SUPPL-103 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125084s103lbl.pdf
03/01/2006 SUPPL-76 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125084s046LBL.pdf
03/01/2006 SUPPL-46 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125084s046LBL.pdf
09/01/2005 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125084_0030lbl.pdf
02/12/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125084lbl.pdf

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