Drug Approval Package

Ambien (Zolpidem Tartrate) Tablets
Company: Lorex Pharmaceuticals
Application No.: 019908
Approval Date: 12/16/1992

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• Approval Letter(s) & Printed Labeling (PDF)  
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)  
• Environmental Assessment (PDF)  
• Pharmacology Review(s) (PDF)  
• Pharmacology Memos & Exclusivity Summary (PDF)
• Statistical Review(s) (PDF)  
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

Date created: July 13, 2005

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