Drug Approval Package
Monistat
Soft Gel Vaginal Insert & External Vulvar Cream
Company: Advanced Care Products
Application No.: 020968
Approval Date: 6/30/1999
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Approval Letter(s) & Final Printed Labeling (PDF) (2.6 MB)
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Medical Review(s)
Part 1 (PDF) (3 MB)
Part 2 (PDF) (3 MB)
Part 3 (PDF) (3 MB)
Part 4 (PDF) (3 MB)
Part 5 (PDF) (3 MB)
Part 6 (PDF) (2.6 MB) -
Chemistry Review(s), Pharmacology Review(s), & Statistical Review(s) (PDF) (2.5 MB)
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Microbiology Review(s) & Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.6 MB)
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Administrative Document(s)/Correspondence
Part 1 (PDF) (2.1 MB)
Part 2 (PDF) (2.3 MB)
Date created: March 30, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.