Application 077794
- Type
- ANDA
- Sponsor
- SUN PHARM INDS
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 |
|---|---|---|---|---|---|---|---|
| A077794-001 | OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2007-10-09 | |
| A077794-002 | OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2007-10-09 | |
| A077794-003 | OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2007-10-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077794-001 | AB |
| A077794-002 | AB |
| A077794-003 | 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 | A077794-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2007-10-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077794-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2007-10-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077794-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2007-10-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077794-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2007-10-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077794-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2007-10-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077794-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2007-10-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077794-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2007-10-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077794-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2007-10-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077794-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2007-10-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077794-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2007-10-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077794-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2007-10-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077794-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2007-10-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077794-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2007-10-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077794-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2007-10-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077794-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2007-10-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077794-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2007-10-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077794-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2007-10-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077794-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2007-10-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077794-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2007-10-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077794-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2007-10-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077794-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2007-10-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077794-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2007-10-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077794-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2007-10-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077794-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2007-10-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077794-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2007-10-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077794-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2007-10-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077794-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2007-10-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077794-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2007-10-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077794-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2007-10-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077794-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2007-10-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077794-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2007-10-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077794-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2007-10-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077794-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2007-10-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077794-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2007-10-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077794-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2007-10-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077794-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2007-10-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077794-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2007-10-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077794-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2007-10-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077794-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2007-10-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077794-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2007-10-09 | 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 | A077794-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077794-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077794-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077794-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077794-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077794-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077794-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077794-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077794-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077794-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077794-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077794-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077794-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077794-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077794-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077794-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077794-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077794-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077794-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077794-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077794-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077794-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077794-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077794-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077794-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077794-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077794-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077794-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077794-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077794-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077794-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077794-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077794-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077794-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077794-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077794-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077794-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077794-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077794-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077794-001 | 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 | Sun Pharmaceutical Industries, Inc. | 7ecd5eef-46f4-407f-9b63-ba65adb3eced | 2026-06-03 | Warnings, Adverse reactions | 077794 ANDA077794 62756-184 62756-183 62756-185 |
| OXCARBAZEPINE | OXCARBAZEPINE | DirectRx | dbea45c2-e166-b557-e053-2995a90a7643 | 2025-01-22 | Warnings, Adverse reactions | 077794 ANDA077794 72189-339 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-6593 | Oxcarbazepine | Oxcarbazepine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-6594 | Oxcarbazepine | Oxcarbazepine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-6595 | Oxcarbazepine | Oxcarbazepine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8153 | Oxcarbazepine | Oxcarbazepine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8153 | Oxcarbazepine | Oxcarbazepine | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8292 | Oxcarbazepine | Oxcarbazepine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8292 | Oxcarbazepine | Oxcarbazepine | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 33261-684 | Oxcarbazepine | Oxcarbazepine | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-841 | Oxcarbazepine | Oxcarbazepine | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-842 | Oxcarbazepine | Oxcarbazepine | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 62756-183 | Oxcarbazepine | Oxcarbazepine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-183 | Oxcarbazepine | Oxcarbazepine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-183 | Oxcarbazepine | Oxcarbazepine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-184 | Oxcarbazepine | Oxcarbazepine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-184 | Oxcarbazepine | Oxcarbazepine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-184 | Oxcarbazepine | Oxcarbazepine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-185 | Oxcarbazepine | Oxcarbazepine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-185 | Oxcarbazepine | Oxcarbazepine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-185 | Oxcarbazepine | Oxcarbazepine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63629-4987 | Oxcarbazepine | Oxcarbazepine | Bryant Ranch Prepack | ANDA | Current |
| 63629-4987 | Oxcarbazepine | Oxcarbazepine | Bryant Ranch Prepack | ANDA | Current |
| 68788-7306 | Oxcarbazepine | Oxcarbazepine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1027 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1027 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1027 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1027 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1027 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1027 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1055 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1055 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1055 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1055 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1055 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1073 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1073 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1842 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1842 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1842 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1842 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1980 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1980 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1980 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 71335-0505 | Oxcarbazepine | Oxcarbazepine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0505 | Oxcarbazepine | Oxcarbazepine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0505 | Oxcarbazepine | Oxcarbazepine | Bryant Ranch Prepack | ANDA | Current |
| 72189-339 | OXCARBAZEPINE | OXCARBAZEPINE | DirectRx | ANDA | Current |