Home Applications 204988 Application 204988
Type ANDA
Sponsor HIKMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RUFINAMIDE RUFINAMIDE TABLET;ORAL 200MG No No 002 RUFINAMIDE RUFINAMIDE TABLET;ORAL 400MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204988-001 RUFINAMIDE RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 A204988-002 RUFINAMIDE RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16
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 3 · 82 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 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204988-001 RUFINAMIDE 200MG TABLET / ORAL AB 2016-05-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204988-002 RUFINAMIDE 400MG TABLET / ORAL AB 2016-05-16 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 A204988-001 PC 2021-11-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204988-002 PC 2021-11-28 782e0a99824c…
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0054-0425 Rufinamide Rufinamide Hikma Pharmaceuticals USA Inc. ANDA Current 0054-0425 Rufinamide Rufinamide Hikma Pharmaceuticals USA Inc. ANDA Current 0054-0426 Rufinamide Rufinamide Hikma Pharmaceuticals USA Inc. ANDA Current 0054-0426 Rufinamide Rufinamide Hikma Pharmaceuticals USA Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 40431 ORIG 2016-06-01 32608 ORIG 2016-05-18