Drug Approval Package
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Brovana (arformoterol tartrate) Inhalation Solution
Company: Sepracor Inc.
NDA: 021912
Approval Date: 10/6/2006
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- Summary Review (PDF)
- Medical Review(s)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s)
- Statistical Review(s) (PDF)
- Microbiology Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s)
- Risk Assessment and Risk Mitigation Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
Date created: April 14, 2009
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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