Drug Approval Package
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Luvox (fluvoxamine maleate) 25mg, 50mg, and 100mg tablets
Company: Solvay Pharmaceuticals, Inc.
NDA: 021519
Approval Date: 12/20/2007
- Approvable Letter(s) (PDF)
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Administrative Document(s) and Correspondence (PDF)
Date created: November 10, 2008
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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