Drug Approval Package
Fosamax(Alendronate Sodium) Tablets
Company: Merck Research Laboratories
Application No.: 20560/S013
Approval Date: 6/8/1999
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Approval Letter(s) (PDF) (600 KB)
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Final Printed Labeling (PDF) (3 MB)
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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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