Drug Approval Package
Aredia
(Pamidronate Disodium for Injection)
Company: Novartis Pharmaceuticals Corporation
Application No.: 20036/S-015
Approval Date: 9/22/1998
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Approval Letter(s) (PDF) (801 KB)
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Medical Review(s)
Part 1 (PDF) (2.4 MB)
Part 2 (PDF) (1.7 MB) -
Chemistry Review(s) & Pharmacology Review(s) (PDF) (1.3 MB)
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Statistical Review(s)
Part 1 (PDF) (1.1 MB)
Part 2 (PDF) (2 MB) -
Clinical Pharmacology Biopharmaceutics Review(s) & Administrative Document(s)/Correspondence (PDF) (2.6 MB)
Date created: September 10, 2001
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