Drug Approval Package

Edex
Company: Schwarz Pharma
Application No.: 020649
Approval Date: 06/12/1997

• Approval Letter(s) (PDF)  

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

• Chemistry Review(s) (PDF)  

• Environmental Assessment (PDF)  

• Pharmacology Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence (PDF)  

Date created: August 8, 2003

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