Drug Approval Package

 Fosamax (Alendronate Sodium) Oral Solution
Company:  Merck & Co., Inc.
Application No.:  021575
Approval Date: 9/17/2003

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) (PDF)  

Date created: April 052005

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