Drug Approval Package
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Biaxin XL Filmtab (Clarithromycin Extended Release Tablets)
Company: Abbott Laboratories
Application No.: 50-775
Approval Date: 3/3/2001
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
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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: October 11, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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