Drug Approval Package
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Vivitrol (Naltrexone)
Company: Alkermes
Application No.: 021897
Approval Date: 04/13/2006
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Approval Letter(s) (PDF)
- Approvable Letter (PDF)
- Printed Labeling (PDF)
- Medical Review(s) (PDF)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF) -
Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
Part 1 (PDF)
Part 2 (PDF) -
Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: January 16, 2008
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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