Drug Approval Package
Humira (Adalimumab) Injection
Company: Abbott Laboratories
Application No.: 125057s0110
Approval Date: 01/18/2008
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- Approval
Letter(s) (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Cross Disipline Team Leader Review (PDF)
- Printed Labeling (PDF)
- Medical Review(s)
Part 1 (PDF)
Part 2 (PDF)
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Chemistry Review(s) (PDF)
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Environmental Assessment (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Other Review(s) (PDF)
Date created: March 24, 2009
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