Drug Approval Package
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Xopenex HFA (Levalbuterol Tartrate) Inhalation Aerosol
Company: Sepracor Inc.
Application No.: 021730
Approval Date: 03/11/2005
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Approval Letter(s) (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)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
Date created: December 132006
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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