Details for New Drug Application (NDA): 201367
NDA 201367 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 201367
| Tradename: | BANZEL |
| Applicant: | Eisai Inc |
| Ingredient: | rufinamide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 201367
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BANZEL | rufinamide | SUSPENSION;ORAL | 201367 | NDA | Eisai Inc. | 62856-584 | 62856-584-46 | 1 BOTTLE in 1 CARTON (62856-584-46) / 460 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 40MG/ML | ||||
| Approval Date: | Mar 3, 2011 | TE: | AB | RLD: | Yes | ||||
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