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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021308

MONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE)
2%,1.2GM
Marketing Status: Over-the-counter
Active Ingredient: MICONAZOLE NITRATE
Proprietary Name: MONISTAT 1 COMBINATION PACK
Dosage Form; Route of Administration: CREAM, INSERT; TOPICAL, VAGINAL
Strength: 2%,1.2GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021308
Product Number: 001
Approval Date: Jun 29, 2001
Applicant Holder Full Name: MEDTECH PRODUCTS INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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