Drug Approval Package

Advair HFA (Fluticasone Propionate and Salmeterol Xinafoate) Inhalation Aerosol
Company:  GlaxoSmithKline
Application No.:  021254
Approval Date: 06/08/2006

• Approval Letter(s) (PDF) 
  

• Approvable Letter (PDF) 
  Part 1 (PDF)  
  Part 2 (PDF)  

• Proprietary Name Review(s) (PDF) 

• Summary Review (PDF) 

• Printed Labeling (PDF) 

• Medical Review(s) (PDF) 
  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) & Correspondence (PDF) 

Date created: May 6, 2008

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