Drug Approval Package

 Ambien CR (Zolpidem Tartrate) Tabelts
Company:  Sanofi-Synthelabo, Inc.
Application No.:  021774
Approval Date: 06/01/2005

• Approval Letter(s) (PDF)

• Approvable 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) & Correspondence (PDF)  

Date created: June 072006

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