Drug Approval Package

Clarinex-D 12 Hour (Desloratadine and Pseudoephedrine Sulfate) Extended-Release Tablets
Company: Schering Corporation
Application No.:  021313
Approval Date: 10/05/2006

• Approval Letter(s) (PDF) 
  

• Approvable Letter (PDF) 

• Printed Labeling (PDF) 

• Medical Review(s) (PDF) 
  Part 1 (PDF)  
  Part 2 (PDF)  

• Chemistry Review(s) (PDF) 

• Pharmacology Review(s) (PDF) 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)
  Part 4 (PDF)  

• Statistical Review(s) (PDF) 

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) 

• Administrative Document(s) & Correspondence (PDF) 

Date created: July 9, 2008

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