Drug Approval Package
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Mentax
(Butenafine HCI) Cream
Company: Bertek Pharmaceuticals Inc.
Application No.: 20-524/S005
Approval Date: 6/6/2001
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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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Statistical Review(s) (PDF)
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Microbiology 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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