Drug Approval Package

Tovalt Odt (zolpidem tartrate) Orally Disintegrating Tablets, 5 and 10 mg
Company: Biovail Laboratories International SRL
NDA: 021412
Approval Date: 4/25/2007

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

• Approvable Letter(s) (PDF)
  
  
• Approval Letter(s) (PDF)
  
  
• Printed Labeling (PDF)
  
  
• Medical Review(s) (PDF)
  
  
• Chemistry Review(s) (PDF)
  
  
• Pharmacology Review(s) (PDF)
  
  
• Microbiology Review(s) (PDF)  
  
  
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
  

• Administrative Document(s) and Correspondence (PDF)

Date created: April 14, 2009

Back to Top    Drugs@FDA

Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.

Note: Documents in PDF format require the Adobe Acrobat Reader®.