Drug Approval Package
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Tasigna (Nilotinib) Oral Capsules
Company: Novartis Pharmaceuticals Corporation
Application No.: 022068
Approval Date: 10/29/2007
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Summary Review (PDF)
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Officer Employee List (PDF)
- Cross Discipline Team Leader Review (PDF)
- Medical Review(s)
Part 1 (PDF)
Part 2 (PDF) -
Chemistry Review(s) (PDF)
- Pharmacology Review(s)
Part 1 (PDF)
Part 2 (PDF) - Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: March 14, 2008
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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