Home Applications 201367 Application 201367
Type NDA
Sponsor EISAI INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BANZEL RUFINAMIDE SUSPENSION;ORAL 40MG/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N201367-001 BANZEL RUFINAMIDE 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N201367-001 AB
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 2 · 43 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 2026-09-14 22:38:34 2026-08 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N201367-001 BANZEL 40MG/ML SUSPENSION / ORAL AB RLD, RS 2011-03-03 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Observed Orange Book patent history# Patent history page 2 of 2 · 46 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N201367-001 6740669 2022-11-14 Drug substance, Drug product 2011-04-01 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N201367-001 6740669*PED 2023-05-14 Pediatric extension f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N201367-001 6740669 2022-11-14 Drug substance, Drug product 2011-04-01 e64feba35796…2022-09-29 23:25 UTC 2022-09 N201367-001 6740669*PED 2023-05-14 Pediatric extension e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N201367-001 6740669 2022-11-14 Drug substance, Drug product 2011-04-01 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N201367-001 6740669*PED 2023-05-14 Pediatric extension cb3db0bc1861…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 62856-584 Banzel rufinamide Eisai Inc. NDA Current 62856-584 Banzel rufinamide Eisai Inc. NDA Current 62856-584 Banzel rufinamide Eisai Inc. NDA Current 62856-584 Banzel rufinamide Eisai Inc. NDA Current 62856-584 Banzel rufinamide Eisai Inc. NDA Current 62856-584 Banzel rufinamide Eisai Inc. NDA Current 62856-584 Banzel rufinamide Eisai Inc. NDA Current 62856-584 Banzel rufinamide Eisai Inc. NDA Current