Drug Approval Package

Luvox (fluvoxamine maleate) 25 mg, 50 mg, and 100 mg tablets
Company: Jazz Pharmaceuticals, Inc
Application No.:  022235
Approval Date: 4/14/2008

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

• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: September 3, 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®.