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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022404

Marketing Status: Prescription
Active Ingredient: MICONAZOLE
Proprietary Name: ORAVIG
Dosage Form; Route of Administration: TABLET; BUCCAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022404
Product Number: 001
Approval Date: Apr 16, 2010
Applicant Holder Full Name: GALT PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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