Home Applications 021911 Application 021911
Type NDA
Sponsor EISAI INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BANZEL RUFINAMIDE TABLET;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 BANZEL RUFINAMIDE TABLET;ORAL 200MG Yes No 003 BANZEL RUFINAMIDE TABLET;ORAL 400MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021911-001 BANZEL RUFINAMIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 N021911-002 BANZEL RUFINAMIDE 200MG TABLET / ORAL AB RLD 2008-11-14 N021911-003 BANZEL RUFINAMIDE 400MG TABLET / ORAL AB RLD, RS 2008-11-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021911-002 BANZEL 200MG TABLET / ORAL AB RLD 2008-11-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021911-003 BANZEL 400MG TABLET / ORAL AB RLD, RS 2008-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021911-001 BANZEL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-11-14 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book patent history# Patent history page 1 of 4 · 138 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021911-001 6740669 2022-11-14 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021911-001 6740669*PED 2023-05-14 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021911-002 6740669 2022-11-14 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021911-002 6740669*PED 2023-05-14 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021911-003 6740669 2022-11-14 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021911-003 6740669*PED 2023-05-14 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021911-001 6740669 2022-11-14 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021911-001 6740669*PED 2023-05-14 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021911-002 6740669 2022-11-14 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021911-002 6740669*PED 2023-05-14 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021911-003 6740669 2022-11-14 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021911-003 6740669*PED 2023-05-14 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021911-001 6740669 2022-11-14 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021911-001 6740669*PED 2023-05-14 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021911-002 6740669 2022-11-14 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021911-002 6740669*PED 2023-05-14 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021911-003 6740669 2022-11-14 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021911-003 6740669*PED 2023-05-14 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021911-001 7750028*PED 2019-04-19 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021911-001 6740669 2022-11-14 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021911-001 6740669*PED 2023-05-14 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021911-002 7750028*PED 2019-04-19 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021911-002 6740669 2022-11-14 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021911-002 6740669*PED 2023-05-14 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021911-003 7750028*PED 2019-04-19 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021911-003 6740669 2022-11-14 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021911-003 6740669*PED 2023-05-14 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021911-001 6740669 2022-11-14 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021911-001 6740669*PED 2023-05-14 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021911-002 6740669 2022-11-14 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021911-002 6740669*PED 2023-05-14 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021911-003 6740669 2022-11-14 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021911-003 6740669*PED 2023-05-14 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021911-001 6740669 2022-11-14 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021911-001 6740669*PED 2023-05-14 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021911-002 6740669 2022-11-14 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021911-002 6740669*PED 2023-05-14 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021911-003 6740669 2022-11-14 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021911-003 6740669*PED 2023-05-14 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021911-001 6740669 2022-11-14 Drug substance, Drug product 87673890dc5c…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 62856-582 Banzel rufinamide Eisai Inc. NDA Current 62856-582 Banzel rufinamide Eisai Inc. NDA Current 62856-582 Banzel rufinamide Eisai Inc. NDA Current 62856-582 Banzel rufinamide Eisai Inc. NDA Current 62856-582 Banzel rufinamide Eisai Inc. NDA Current 62856-582 Banzel rufinamide Eisai Inc. NDA Current 62856-582 Banzel rufinamide Eisai Inc. NDA Current 62856-582 Banzel rufinamide Eisai Inc. NDA Current 62856-583 Banzel rufinamide Eisai Inc. NDA Current 62856-583 Banzel rufinamide Eisai Inc. NDA Current 62856-583 Banzel rufinamide Eisai Inc. NDA Current 62856-583 Banzel rufinamide Eisai Inc. NDA Current 62856-583 Banzel rufinamide Eisai Inc. NDA Current 62856-583 Banzel rufinamide Eisai Inc. NDA Current 62856-583 Banzel rufinamide Eisai Inc. NDA Current 62856-583 Banzel rufinamide Eisai Inc. NDA Current