FDA Application
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Ketoconazole
Tabelts
Company: Novopharm NC, Inc. Agent for: Novopharm Limited
Application No.: 74-971
Approval Date: 6/15/1999
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Chemistry Review(s) (PDF)
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Bioequivalence Review(s) (PDF)
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Correspondence (PDF)
Date created: November 20, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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