Home Applications 214748 Application 214748
Type ANDA
Sponsor SUNSHINE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BRIVARACETAM BRIVARACETAM TABLET;ORAL 10MG No No 002 BRIVARACETAM BRIVARACETAM TABLET;ORAL 25MG No No 003 BRIVARACETAM BRIVARACETAM TABLET;ORAL 50MG No No 004 BRIVARACETAM BRIVARACETAM TABLET;ORAL 75MG No No 005 BRIVARACETAM BRIVARACETAM TABLET;ORAL 100MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214748-001 BRIVARACETAM BRIVARACETAM 10MG TABLET / ORAL AB 2022-06-09 A214748-002 BRIVARACETAM BRIVARACETAM 25MG TABLET / ORAL AB 2022-06-09 A214748-003 BRIVARACETAM BRIVARACETAM 50MG TABLET / ORAL AB 2022-06-09 A214748-004 BRIVARACETAM BRIVARACETAM 75MG TABLET / ORAL AB 2022-06-09 A214748-005 BRIVARACETAM BRIVARACETAM 100MG TABLET / ORAL AB 2022-06-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 · 140 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 A214748-001 BRIVARACETAM 10MG TABLET / ORAL AB 2022-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214748-002 BRIVARACETAM 25MG TABLET / ORAL AB 2022-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214748-003 BRIVARACETAM 50MG TABLET / ORAL AB 2022-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214748-004 BRIVARACETAM 75MG TABLET / ORAL AB 2022-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214748-005 BRIVARACETAM 100MG TABLET / ORAL AB 2022-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214748-001 BRIVARACETAM 10MG TABLET / ORAL 2022-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214748-002 BRIVARACETAM 25MG TABLET / ORAL 2022-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214748-003 BRIVARACETAM 50MG TABLET / ORAL 2022-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214748-004 BRIVARACETAM 75MG TABLET / ORAL 2022-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214748-005 BRIVARACETAM 100MG TABLET / ORAL 2022-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214748-001 BRIVARACETAM 10MG TABLET / ORAL 2022-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214748-002 BRIVARACETAM 25MG TABLET / ORAL 2022-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214748-003 BRIVARACETAM 50MG TABLET / ORAL 2022-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214748-004 BRIVARACETAM 75MG TABLET / ORAL 2022-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214748-005 BRIVARACETAM 100MG TABLET / ORAL 2022-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214748-001 BRIVARACETAM 10MG TABLET / ORAL 2022-06-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214748-002 BRIVARACETAM 25MG TABLET / ORAL 2022-06-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214748-003 BRIVARACETAM 50MG TABLET / ORAL 2022-06-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214748-004 BRIVARACETAM 75MG TABLET / ORAL 2022-06-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214748-005 BRIVARACETAM 100MG TABLET / ORAL 2022-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214748-001 BRIVARACETAM 10MG TABLET / ORAL 2022-06-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214748-002 BRIVARACETAM 25MG TABLET / ORAL 2022-06-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214748-003 BRIVARACETAM 50MG TABLET / ORAL 2022-06-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214748-004 BRIVARACETAM 75MG TABLET / ORAL 2022-06-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214748-005 BRIVARACETAM 100MG TABLET / ORAL 2022-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214748-001 BRIVARACETAM 10MG TABLET / ORAL 2022-06-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214748-002 BRIVARACETAM 25MG TABLET / ORAL 2022-06-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214748-003 BRIVARACETAM 50MG TABLET / ORAL 2022-06-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214748-004 BRIVARACETAM 75MG TABLET / ORAL 2022-06-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214748-005 BRIVARACETAM 100MG TABLET / ORAL 2022-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214748-001 BRIVARACETAM 10MG TABLET / ORAL 2022-06-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214748-002 BRIVARACETAM 25MG TABLET / ORAL 2022-06-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214748-003 BRIVARACETAM 50MG TABLET / ORAL 2022-06-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214748-004 BRIVARACETAM 75MG TABLET / ORAL 2022-06-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214748-005 BRIVARACETAM 100MG TABLET / ORAL 2022-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214748-001 BRIVARACETAM 10MG TABLET / ORAL 2022-06-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214748-002 BRIVARACETAM 25MG TABLET / ORAL 2022-06-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214748-003 BRIVARACETAM 50MG TABLET / ORAL 2022-06-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214748-004 BRIVARACETAM 75MG TABLET / ORAL 2022-06-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214748-005 BRIVARACETAM 100MG TABLET / ORAL 2022-06-09 5bbf6a4d5a75…
Observed Orange Book normalized TE history# 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.
Documents# Document, Submission type, Date table Document Submission type Date 71683 ORIG 2022-08-01