Drug Approval Package

Synera (Lidocaine and Tertracaine) Topical Patch
Company: Zars, Inc.
Application No.:  021623
Approval Date: 06/23/2005

• Approval Letter(s) (PDF)  

• Approvable Letter (PDF)  

• Printed Labeling (PDF)  

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

• Chemistry Review(s) (PDF)  

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

• Statistical Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: March 14, 2008

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