Drug Approval Package

Fosamax(Alendronate Sodium) Tablets
Company:  Merck Research Laboratories
Application No.:  20560/S013
Approval Date: 6/8/1999

• Approval Letter(s) (PDF) (600 KB)

• Final Printed Labeling (PDF) (3 MB)

• Medical Review(s)
  Part 1 (PDF) (2.9 MB)
  Part 2 (PDF) (2.9 MB)
  Part 3 (PDF) (2.5 MB)
  Part 4 (PDF) (2.8 MB)
  Part 5 (PDF) (2.9 MB)
  Part 6 (PDF) (2.5 MB)

• Statistical Review(s)
  Part 1 (PDF) (2.1 MB)
  Part 2 (PDF) (1.9 MB)

• Administrative Document(s)/Correspondence (PDF) (3 MB)

Date created: March 30, 2001

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