Drug Approval Package

Triglide (Fenofibrate) Tablets
Company: Skye Pharma, Inc.
Application No.:  021350
Approval Date: 05/07/2005

• Approval Letter(s) (PDF)  

• Approvable Letter
  Part 1 (PDF)  
  Part 2 (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created:  September 10, 2007

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