Drug Approval Package

Lamisil (terbinafine hydrochloride) Oral Granules, 125 mg & 187.5 mg
Company: Novartis Pharmaceuticals Corporation
NDA: 022071
Approval Date: 9/28/2007

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

• 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) and Correspondence (PDF)

Date created: March 12, 2009

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