FDA Application
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M-Zole 3 Combination
Pack [Miconazole Nitrate Vaginal Suppositories USP and Miconazole Cream USP
Company: Alpharma, U.S. Pharmaceuticals Division
Application No.: 74-926
Approval Date: 4/16/1999
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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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