Drug Approval Package: HUMIRA (adalimumab)

Company:  ABBVIE INC
Application No.:  125057
Approval Date: December 31, 2002

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 (PDF)
  • Part 1 (PDF)
  • Part 2 (PDF)
  • Part 3 (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

Last updated: April 7, 2017

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®.