Drug Approval Package
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Monistat
3 (Miconazole Nitrate 4%) Vaginal Cream
Company: Advanced Care Products
Application No.: 20827
Approval Date: 3/30/1998
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
Part 1 (PDF) Part 2 (PDF) -
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: September 10, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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