Details for New Drug Application (NDA): 021911
NDA 021911 describes BANZEL, which is a drug marketed by Eisai Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the BANZEL profile page.
The generic ingredient in BANZEL is rufinamide. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the rufinamide profile page.
The generic ingredient in BANZEL is rufinamide. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the rufinamide profile page.
Summary for 021911
| Tradename: | BANZEL |
| Applicant: | Eisai Inc |
| Ingredient: | rufinamide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021911
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BANZEL | rufinamide | TABLET;ORAL | 021911 | NDA | Eisai Inc. | 62856-582 | 62856-582-04 | 4 TABLET, FILM COATED in 1 BOTTLE (62856-582-04) |
| BANZEL | rufinamide | TABLET;ORAL | 021911 | NDA | Eisai Inc. | 62856-582 | 62856-582-52 | 120 TABLET, FILM COATED in 1 BOTTLE (62856-582-52) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 14, 2008 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Nov 14, 2008 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Nov 14, 2008 | TE: | AB | RLD: | Yes | ||||
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