Drug Approval Package

 Cozaar (Losartan Potassium) Tablets
Company:  Merck and Co., Inc.
Application No.:  020386/S019 & S029
Approval Date: 3/11/2004

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)

• Environmental Assessment (PDF)

• Statistical Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: June /4/2004

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