Drug Approval Package

Ondansetron Injection, USP, 32 mg/50 mL iso-osmotic sodium chloride solution PreMix in Intravia Plastic Container
Company: Baxter Healthcare Corportation
NDA: 021915
Approval Date: 12/27/2006

• Approvable Letter(s) (PDF)
• Approval Letter(s) (PDF)
• Printed Labeling (PDF)
• Medical Review(s)
  • Part 1 (PDF)  
  • Part 2 (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) and Correspondence (PDF)
  
  • Part 1 (PDF)
  • Part 2 (PDF)

Date created: October 3, 2008

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