Drug Approval Package
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Fosamax (Alendronate Sodium) Tablets
Company: Merck Research Laboratories
Application No.: 20560/S012
Approval Date: 6/16/1999
- Approval Letter(s) (PDF) (819 KB)
- Final Printed Labeling (PDF) (3 MB)
- Medical Review(s)
Part 1 (PDF) (2.8 MB)
Part 2 (PDF) (3 MB)
Part 3 (PDF) (3 MB)
Part 4 (PDF) (2.3 MB)
Part 5 (PDF) (2.5 MB)
Part 6 (PDF) (2.5 MB) - Statistical Review(s) (PDF) (1.7 MB)
- Administrative Document(s)/Correspondence
Part 1 (PDF) (2.4 MB)
Part 2 (PDF) (2.2 MB)
Part 3 (PDF) (2.5 MB)
Part 4 (PDF) (2.2 MB)
Part 5 (PDF) (2.7 MB)
Date created: March 30, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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