Drug Approval Package

Fosamax(Alendronate Sodium) Tablets
Company: Merck Research Laboratories
Application No.: 020560/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

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.