Drug Approval Package
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Stavzor (valproic acid) Delayed Release Capsules, 125 mg, 250 mg and 500 mg
Company: Banner Pharmacaps Inc.
Application No.: 022152
Approval Date: 7/29/2008
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)
- Cross Discipline Team Leader Review (PDF)
- Printed Labeling (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Action Letter(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: August 25, 2009
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