Drug Approval Package

Drug Name: Aerospan (flunisolide HFA, 80 mcg) Inhalation Aerosol
Company: Forest Laboratories, Inc.
NDA: 021247
Approval Date: 1/27/2006

• Approvable Letter(s) (PDF)
• 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) (PDF)
• Statistical Review(s) (PDF)  
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  
• Proprietary Name Review(s) (PDF)
• Administrative Document(s) and Correspondence (PDF)
  
  • Part 1 (PDF)
  • Part 2 (PDF)

Date created: December 22, 2008

Back to Top    Drugs@FDA

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