Drug Approval Package

Quinine Sulfate Capsules
Company: Mutual Pharmaceutical Company, Inc.
Application No.:  021799
Approval Date: 08/12/2005

• Approval Letter(s) (PDF) 

• Proprietary Name Review(s) (PDF) 

• Summary Review (PDF) 

• Printed Labeling (PDF) 

• Medical Review(s) (PDF) 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)
  Part 4 (PDF)  
  Part 5 (PDF)  
  Part 6 (PDF)

• Chemistry Review(s) (PDF) 

• Pharmacology Review(s) (PDF) 

• Statistical Review(s) (PDF) 

• Microbiology Review(s) (PDF) 

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) 

• Administrative Document(s) & Correspondence (PDF) 

Date created: July 9, 2008

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