Application 078069
- Type
- ANDA
- Sponsor
- BRECKENRIDGE PHARM
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078069-001 | OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2008-01-11 | |
| A078069-002 | OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2008-01-11 | |
| A078069-003 | OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2008-01-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078069-001 | AB |
| A078069-002 | AB |
| A078069-003 | 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.
| 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 | A078069-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2008-01-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078069-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2008-01-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078069-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2008-01-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078069-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2008-01-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078069-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2008-01-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078069-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2008-01-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078069-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2008-01-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078069-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2008-01-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078069-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2008-01-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078069-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2008-01-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078069-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2008-01-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078069-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2008-01-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078069-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2008-01-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078069-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2008-01-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078069-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2008-01-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078069-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2008-01-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078069-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2008-01-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078069-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2008-01-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078069-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2008-01-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078069-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2008-01-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078069-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2008-01-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078069-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2008-01-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078069-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2008-01-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078069-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2008-01-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078069-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2008-01-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078069-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2008-01-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078069-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2008-01-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078069-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2008-01-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078069-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2008-01-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078069-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2008-01-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078069-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2008-01-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078069-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2008-01-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078069-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2008-01-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078069-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2008-01-11 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078069-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2008-01-11 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078069-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2008-01-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078069-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2008-01-11 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078069-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2008-01-11 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078069-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2008-01-11 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078069-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2008-01-11 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078069-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078069-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078069-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078069-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078069-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078069-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078069-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078069-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078069-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078069-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078069-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078069-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078069-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078069-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078069-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078069-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078069-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078069-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078069-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078069-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078069-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078069-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078069-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078069-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078069-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078069-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078069-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078069-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078069-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078069-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078069-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078069-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078069-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078069-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078069-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078069-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078069-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078069-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078069-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078069-001 | AB | 1 | 8072bd15b7f6… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | ffc8d10c-0049-4fe5-beb8-79cc6a197ede | 2026-07-23 | Warnings, Adverse reactions | 078069 ANDA078069 70518-2370 |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | b571ee0f-3c2a-4c55-9c2b-e00014e2ec7a | 2026-07-21 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | 85a9bdee-4d10-4097-ae3d-0bf8d844a11b | 2026-07-08 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | Major Pharmaceuticals | b1d54def-057d-4608-bc8f-1d967ac3ec91 | 2026-06-15 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | fcf5044a-8cfd-47d5-9f47-8f6674843c24 | 2026-06-08 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | Major Pharmaceuticals | 567c0777-9bc5-45a9-ba25-959dd76d0e05 | 2026-04-30 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | Breckenridge Pharmaceutical, Inc. | 54fb494e-bce4-442d-954a-757f9851e81e | 2026-04-13 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | 244f9a68-5ab4-46b8-a01f-538572fd3c5f | 2026-02-03 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | 6d2a6cac-f16b-4e6c-8f75-3afffb0a0f3b | 2026-02-03 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | Golden State Medical Supply, Inc. | b9db5c45-8b51-449b-b4af-1a235c08f189 | 2025-12-11 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | a1b6a698-f7d9-4adb-9e38-b63e7a85e2b3 | 2025-10-24 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | 1176d5f5-3447-4925-aed8-1a1cb4b5989d | 2025-10-13 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | Coupler LLC | 3f15c889-4386-850b-e063-6294a90a8dbf | 2025-09-18 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | Preferred Pharmaceuticals Inc. | e156339c-f79e-4a20-b9da-f50bea948213 | 2025-09-05 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | Cardinal Health 107, LLC | 4ebcb0e5-1c93-4b3f-8749-6835c56afce5 | 2025-09-04 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | Bryant Ranch Prepack | 38694974-3dc6-42b5-bdf9-b5354e35330b | 2024-10-25 | Warnings, Adverse reactions | 078069 ANDA078069 71335-0090 |
| OXCARBAZEPINE | OXCARBAZEPINE | Bryant Ranch Prepack | d8edaa2b-3bab-4030-a4e3-0c77f7655731 | 2024-07-16 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | Bryant Ranch Prepack | 78f196d4-110e-45b1-813a-725f52c1a4eb | 2024-04-04 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | Bryant Ranch Prepack | d3c7a3b8-b9a2-4a5f-98b3-0ed02eca3433 | 2024-04-02 | Warnings, Adverse reactions | 078069 ANDA078069 |
| OXCARBAZEPINE | OXCARBAZEPINE | Bryant Ranch Prepack | 255f64ba-7667-48e6-8599-3b598bf6f4e9 | 2024-01-12 | Warnings, Adverse reactions | 078069 ANDA078069 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70518-2370 | OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2370 | OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2377 | OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2377 | OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2377 | OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2377 | OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 71335-0090 | OXCARBAZEPINE | OXCARBAZEPINE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0090 | OXCARBAZEPINE | OXCARBAZEPINE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0090 | OXCARBAZEPINE | OXCARBAZEPINE | Bryant Ranch Prepack | ANDA | Current |