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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017450

MONISTAT 7 (MICONAZOLE NITRATE)
2%
Marketing Status: Over-the-counter
Active Ingredient: MICONAZOLE NITRATE
Proprietary Name: MONISTAT 7
Dosage Form; Route of Administration: CREAM; VAGINAL
Strength: 2%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N017450
Product Number: 002
Approval Date: Feb 15, 1991
Applicant Holder Full Name: MEDTECH PRODUCTS INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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