Drug Approval Package

RAPAFLO (Silodosin) Capsules
Company:  Watson Laboratories, Inc.
Application No.:  022206
Approval Date: 10/08/2008

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

Approval Letter(s) (PDF) 

• Summary Review (PDF) 

• Officer/Employee List (PDF) 

• Printed Labeling (PDF) 

• Medical Review(s) 

  • Part 1 (PDF) 
  • Part 2 (PDF) 
  • Part 3 (PDF)

• Pharmacology Review(s) 

  • Part 1 (PDF) 
  • Part 2 (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) 

• Other Review(s) (PDF) 

• Administrative Document(s) & Correspondence (PDF) 

Date created: November 14, 2008

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