Drug Approval Package

Synercid (Quinupristin/Dalfopristin) I.V.
Company:  Rhone-Poulenc Rorer Pharmaceuticals
Application No.:  50-747 & 50-748
Approval Date: 9/21/1999

• 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)  

• Microbiology Review(s) (PDF)   

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence (PDF)  
  Part 1 (PDF)
  Part 2 (PDF)

Date created: July 13, 2001

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