Drug Approval Package
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Sabril (Vigabatrin) Tablets
Company: Lundbeck Inc.
Application No.: 020427
Approval Date: 8/21/2009
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Summary Review (PDF
- Risk Evaluation and Mitigation Strategy (PDF)
- Officer/Employee List (PDF)
- Office Director Memo (PDF)
- Other Action Letter(s) (PDF)
- Printed Labeling (PDF)
- Medical Review(s)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s)
- Statistical Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s)
- Risk Assessment and Risk Mitigation Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: November 23, 2009
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
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