Home Applications 207717 Application 207717
Type ANDA
Sponsor RUBICON RESEARCH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 150MG No No 002 OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 300MG No No 003 OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 600MG 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 A207717-001 OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 A207717-002 OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 A207717-003 OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 2 · 48 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 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 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.