FDA Application

Erbitux (Cetuximab)
Company: ImClone Systems, Inc.
Application No.: 125084
Approval Date: 2/12/2004

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

• Approval Letter(s) (PDF)
  

• Printed Labeling (PDF)
  

• Medical Review(s)
  Part 1 (PDF)
  Part 2 (PDF)
  Part 3 (PDF)

• Chemistry Review(s) (PDF)
  

• Pharmacology Review(s)
  Part 1 (PDF)
  Part 2 (PDF)
  Part 3 (PDF)

• Statistical Review(s) (PDF)
  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
  

• Administrative Document(s) & Correspondence (PDF)

Date created: September 13, 2004

Back to Top    Drugs@FDA

Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.

Note: Documents in PDF format require the Adobe Acrobat Reader®.