Drug Approval Package
Tektuma (Aliskiren) Tablets
Company: Novartis Pharmaceuticals Corporation
Application No.: 021985
Approval Date: 03/05/2007
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Chemistry Review(s) (PDF)
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Environmental Assessment (PDF)
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Pharmacology Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF) -
Statistical Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF) -
Administrative Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Date created: April 30, 2007
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