Drug Approval Package
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Adderall
XR CapsuleCompany: Shire Laboratories, Inc.
Application No.: 21-303
Approval Date: 10/11/2001
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) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Statistical Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Administrative Document(s) (PDF)
- Correspondence (PDF)
Date created: November 20, 2001
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®.
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