Drug Approval Package

Sanctura XR (Trospium Chloride) Extended Release Capsules
Company: Indevus Pharmaceutical, Inc.
Application No.:  022103s000
Approval Date: 08/03/2007

• Approval Letter(s) (PDF) 

• Printed Labeling (PDF) 

• Summary Review (PDF) 

• Medical Review(s) (PDF) 

• Chemistry Review(s) (PDF) 

• Pharmacology Review(s) (PDF) 

• Statistical Review(s) (PDF) 

• Microbiology Review(s) (PDF) 

• Clinical Pharmacology Biopharmaceutics 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

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