Drug Approval Package
Zometa (Zoledronic Acid) Injection
Company: Novartis Pharmaceuticals Corporation
Application No.: 21-386
Approval Date: 2/22/2002
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF) -
Chemistry Review(s) (PDF)
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Environmental Assessment (PDF)
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Administrative Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Date created: July 1, 2002
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