Drug Approval Package

Drug Name: Septocaine (articaine)
Company: Arent Fox PLLC
NDA: 022010
Approval Date: 3/30/2006

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)
• Medical Review(s)
  • Part 1 (PDF)  
  • Part 2 (PDF)  
  • Part 3 (PDF)  
• Chemistry Review(s) (PDF)
• Pharmacology Review(s)
  
• Statistical Review(s)
  
• Microbiology Review(s)
  
• Clinical Pharmacology Biopharmaceutics Review(s)
  
• Proprietary Name Review(s) (PDF)
• Administrative Document(s) and Correspondence (PDF)
  

Date created: September 5, 2008

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.