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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 201367

Marketing Status: Prescription
Active Ingredient: RUFINAMIDE
Proprietary Name: BANZEL
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 40MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N201367
Product Number: 001
Approval Date: Mar 3, 2011
Applicant Holder Full Name: EISAI INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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