Home Applications 204964 Application 204964
Type ANDA
Sponsor LUPIN LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RUFINAMIDE RUFINAMIDE TABLET;ORAL 100MG No No 002 RUFINAMIDE RUFINAMIDE TABLET;ORAL 200MG No No 003 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204964-001 RUFINAMIDE RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 A204964-002 RUFINAMIDE RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 A204964-003 RUFINAMIDE RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17
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 · 81 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 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68180-802 RUFINAMIDE rufinamide Lupin Pharmaceuticals, Inc. ANDA Current 68180-802 RUFINAMIDE rufinamide Lupin Pharmaceuticals, Inc. ANDA Current 68180-803 RUFINAMIDE rufinamide Lupin Pharmaceuticals, Inc. ANDA Current 68180-803 RUFINAMIDE rufinamide Lupin Pharmaceuticals, Inc. ANDA Current 68180-804 RUFINAMIDE rufinamide Lupin Pharmaceuticals, Inc. ANDA Current 68180-804 RUFINAMIDE rufinamide Lupin Pharmaceuticals, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 72041 ORIG 2022-09-08