Drug Approval Package

 Codeprex (Codeine Polistirex & Chlorpheniramine Polistirex) ER Suspension
Company:  Celltech Pharmaceuticals, Inc.
Application No.:  021369
Approval Date: 6/21/2004

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

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

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: March 312005

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