Drug Approval Package

Intuniv (guanfacine) extended-release 1 mg, 2 mg, 3 mg, and 4 mg tablets
Company: Shire Pharmaceuticals, Inc.
Application No.: 022037
Approval Date: 9/02/2009

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• Summary Review (PDF)
• Officer/Employee List (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)
• Proprietary Name Review(s) (PDF)
• Other Action Letter(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: July 9, 2010

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