Drug Approval Package
Aplenzin (Bupropion Hydrobromide) Extended-Release Tablets
Company: Biovail Laboratories International
Application No.: 022108
Approval Date: 4/23/2008
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- Approval Letter(s) (PDF)
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Summary Review (PDF)
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Officer/Employee List (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
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Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
Date created: April 07, 2009
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