Drug Approval Package
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Sanctura XR (Trospium Chloride) Extended Release Capsules
Company: Indevus Pharmaceutical, Inc.
Application No.: 022103s000
Approval Date: 08/03/2007
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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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Medical Review(s) (PDF)
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Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
- Risk Assessment and Risk Mitigation Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: July 11, 2008
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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