Drug Approval Package
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Pylera (Biskalcitrate, Metronidazole and Tetracycline Hydrochloride) Capsules
Company: Axcan Scandipharm, Inc.
Application No.: 050786
Approval Date: 09/28/2006
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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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Microbiology Review(s) (PDF)
Date created: November 222006
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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