Drug Approval Package

Adderall XR (Mixed Salts of a Single-Entity Amphetamine Product) Extended Release Tablets
Company: Shire Laboratories, Inc.
Application No.:  021303s001
Approval Date: 05/22/2002

• Approval Letter(s) (PDF)  

• Approvable Letter (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created:  June 22, 2007

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