Drug Approval Package
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Xopenex
(Levalbuterol HCI) Inhalation Solution
Company: Sepracor Inc.
Application No.: 20-837
Approval Date: 3/25/1999
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
Part 1 (PDF) Part 2 (PDF) -
Chemistry Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Correspondence (PDF)
Date created: June 20, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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