Drug Approval Package

Morphine Sulfate Oral Solution, 10mg/5 mL and 20 mg/5 mL(NDA 022-195) and Morphine Sulfate Tablets, 15 mg and 30 mg (NDA 022-207)
Company: Roxane Laboratories, Inc.
NDA: 022195 and 022207
Approval Date: 3/17/2008

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

• Approval Letter(s) (PDF)
  
  
• Printed Labeling (PDF)
  
  
• Summary Review (PDF)
  
  
• Officer/Employee List (PDF)
  
  
• Office Director Memo (PDF)
   
• Chemistry Review(s) (PDF)
  
  
• Pharmacology Review(s) (PDF)
  
  
• Microbiology Review(s) (PDF)
  
  
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
  
  
• Risk Assessment and Risk Mitigation Review(s) (PDF)

• Administrative Document(s) and Correspondence
  • Part 1 (PDF)
  • Part 2 (PDF)

Date created: April 1, 2009

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