Drug Approval Package

Tri-Luma (Fluocinolone Acetonide/Hydroquinone/Tretinoin) Cream
Company:  Hill Dermaceuticals, Inc.
Application No.:  21-112
Approval Date: 1/18/2002

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

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

• Chemistry Review(s) (PDF)  

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

• Statistical Review(s) (PDF)  

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

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence 
  Part 1 (PDF)  
  Part 2 (PDF)

Date created: April 20, 2006

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