Drug Approval Package

 Clarinex-D 24 Hour (Desloratadine/Pseudoephedrine Sulfate) Extended-Release Tablets
Company: Schering Corporation
Application No.:  021605
Approval Date: 03/03/2005

• 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)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: May 09 , 2007

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