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