Drug Approval Package
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Alinia (Nitazoxanide) Tablets
Company: Romark Laboratories
Application No.: 021818 & 021498s003
Approval Date: 06/16/2005
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Approval Letter(s) (PDF)
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Approvable Letter (PDF)
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Printed Labeling (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)
Part 1 (PDF)
Part 2 (PDF)
Date created: April 04, 2002
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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