Details for New Drug Application (NDA): 021911
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NDA 021911 describes BANZEL, which is a drug marketed by Eisai Inc and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the BANZEL profile page.
The generic ingredient in BANZEL is rufinamide. There are seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the rufinamide profile page.
The generic ingredient in BANZEL is rufinamide. There are seven drug master file entries for this compound. Ten 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: | 1 |
| Formulation / Manufacturing: | see details |
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DISCN | Dosage: | TABLET;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 14, 2023 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Nov 14, 2008 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 14, 2023 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Nov 14, 2008 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 14, 2023 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 021911
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-001 | Nov 14, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-001 | Nov 14, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-002 | Nov 14, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-003 | Nov 14, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-003 | Nov 14, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-003 | Nov 14, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-002 | Nov 14, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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