Drug Approval Package
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Lotrimin
Ultra (Butenafine Hydrochloride) Cream
Company: Schering-Plough HealthCare Products
Application No.: 21-307
Approval Date: 12/7/2001
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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)
Date created: November 20, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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