Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021911

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BANZEL (RUFINAMIDE)
200MG
Marketing Status: Prescription

Active Ingredient: RUFINAMIDE
Proprietary Name: BANZEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021911
Product Number: 002
Approval Date: Nov 14, 2008
Applicant Holder Full Name: EISAI INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BANZEL (RUFINAMIDE)
400MG
Marketing Status: Prescription

Active Ingredient: RUFINAMIDE
Proprietary Name: BANZEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021911
Product Number: 003
Approval Date: Nov 14, 2008
Applicant Holder Full Name: EISAI INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BANZEL (RUFINAMIDE)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: RUFINAMIDE
Proprietary Name: BANZEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021911
Product Number: 001
Approval Date: Nov 14, 2008
Applicant Holder Full Name: EISAI INC
Marketing Status:  Discontinued
Patent and Exclusivity Information