Drug Approval Package
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Zyflo CR (zileuton) extended release tablets
Company: Critical Therapeutics, Inc.
NDA: 022052
Approval Date: 5/30/2007
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- Medical Review(s)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Statistical Review(s) (PDF)
- Microbiology Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Administrative Document(s) and Correspondence (PDF)
Date created: October 3, 2008
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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