Application 021285
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRILEPTAL | OXCARBAZEPINE | SUSPENSION;ORAL | 300MG/5ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021285-001 | TRILEPTAL | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021285-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021285-001 | TRILEPTAL | 300MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 2001-05-25 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N021285-001 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N021285-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021285-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021285-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021285-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021285-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021285-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021285-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021285-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021285-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021285-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021285-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021285-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021285-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021285-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021285-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021285-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021285-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021285-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021285-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021285-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021285-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021285-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021285-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021285-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021285-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021285-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021285-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021285-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021285-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021285-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021285-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021285-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021285-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021285-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021285-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021285-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021285-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021285-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021285-001 | AB | 1 | 3a93d1ddd44b… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021285-001 | 8119148 | 2020-12-19 | U-724 | Drug product | 2012-03-08 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021285-001 | 8119148*PED | 2021-06-19 | Pediatric extension | 74a2ff9319b5… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021285-001 | 8119148*PED | 2021-06-19 | Pediatric extension | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021285-001 | 8119148*PED | 2021-06-19 | Pediatric extension | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021285-001 | 8119148*PED | 2021-06-19 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021285-001 | 8119148 | 2020-12-19 | U-724 | Drug product | 2012-03-08 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021285-001 | 8119148*PED | 2021-06-19 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021285-001 | 8119148 | 2020-12-19 | U-724 | Drug product | 2012-03-08 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021285-001 | 8119148*PED | 2021-06-19 | Pediatric extension | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021285-001 | 8119148 | 2020-12-19 | U-724 | Drug product | 2012-03-08 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021285-001 | 8119148*PED | 2021-06-19 | Pediatric extension | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021285-001 | 8119148 | 2020-12-19 | U-724 | Drug product | 2012-03-08 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021285-001 | 8119148*PED | 2021-06-19 | Pediatric extension | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021285-001 | 8119148 | 2020-12-19 | U-724 | Drug product | 2012-03-08 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021285-001 | 8119148*PED | 2021-06-19 | Pediatric extension | ea99ee380514… |
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 | Ajanta Pharma USA Inc. | d947e9b1-2a15-4048-bb4e-fe56b6851848 | 2025-11-30 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | Bionpharma Inc. | ec033897-21b4-4d08-83de-042783e89251 | 2025-11-28 | Warnings, Adverse reactions | OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | a1b6a698-f7d9-4adb-9e38-b63e7a85e2b3 | 2025-10-24 | Warnings, Adverse reactions | OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | 1176d5f5-3447-4925-aed8-1a1cb4b5989d | 2025-10-13 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | Amneal Pharmaceuticals LLC | 2515391e-3a88-4226-92e5-f641c8409fe5 | 2025-10-01 | Warnings, Adverse reactions | OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | Coupler LLC | 3f15c889-4386-850b-e063-6294a90a8dbf | 2025-09-18 | Warnings, Adverse reactions | OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | Preferred Pharmaceuticals Inc. | e156339c-f79e-4a20-b9da-f50bea948213 | 2025-09-05 | Warnings, Adverse reactions | OXCARBAZEPINE |
| oxcarbazepine | OXCARBAZEPINE | Macleods Pharmaceuticals Limited | 962098cc-2d84-4723-a296-b110f1fd659e | 2025-08-29 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | Marlex Pharmaceuticals, Inc | d3684d55-0564-4849-bdf6-b91f22a3e28c | 2025-06-25 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | Ingenus Pharmaceuticals, LLC | 70798ca9-0eda-49c0-8a7c-b775b6ae3d69 | 2025-04-12 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | Proficient Rx LP | 433d9d03-a36e-42c6-8e4d-f333ed60e45a | 2025-03-01 | Warnings, Adverse reactions | OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | NorthStar RxLLC | 1746d95f-c529-45ba-a520-0c135e8edda8 | 2025-02-03 | Warnings, Adverse reactions | OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | DirectRx | dbea45c2-e166-b557-e053-2995a90a7643 | 2025-01-22 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | Bryant Ranch Prepack | 23137a89-cbd0-4a5f-8220-f26b7ba54330 | 2025-01-21 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | AvPAK | fd8da0e9-d69b-7587-e053-6294a90a33c0 | 2025-01-09 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | EPIC PHARMA, LLC | 62ab716b-f05f-454d-95b3-1a382cdf7226 | 2025-01-07 | Warnings, Adverse reactions | OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | Novadoz Pharmaceuticals LLC | 03bec567-a9c3-4d82-9679-fec5324d0df6 | 2024-11-18 | Warnings, Adverse reactions | OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | Bryant Ranch Prepack | 38694974-3dc6-42b5-bdf9-b5354e35330b | 2024-10-25 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | Direct_rx | 21b0cc84-b64a-75de-e063-6294a90a9dd0 | 2024-09-09 | Warnings, Adverse reactions | OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | Bryant Ranch Prepack | d8edaa2b-3bab-4030-a4e3-0c77f7655731 | 2024-07-16 | Warnings, Adverse reactions | OXCARBAZEPINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0357 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0357 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0357 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0357 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0357 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0357 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0357 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0781-6270 | Oxcarbazepine | oxcarbazepine | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-6270 | Oxcarbazepine | oxcarbazepine | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-6270 | Oxcarbazepine | oxcarbazepine | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83529 | SUPPL | 2025-09-26 |
| 83528 | SUPPL | 2025-09-26 |
| 83436 | SUPPL | 2025-09-25 |
| 79544 | SUPPL | 2024-09-05 |
| 79542 | SUPPL | 2024-09-05 |
| 57416 | SUPPL | 2019-02-04 |
| 57137 | SUPPL | 2019-01-08 |
| 53500 | SUPPL | 2018-03-28 |
| 53247 | SUPPL | 2018-03-23 |
| 53246 | SUPPL | 2018-03-23 |
| 50491 | SUPPL | 2017-11-27 |
| 50490 | SUPPL | 2017-11-27 |
| 50461 | SUPPL | 2017-11-20 |
| 47727 | SUPPL | 2017-03-28 |
| 47667 | SUPPL | 2017-03-24 |
| 14885 | SUPPL | 2014-07-08 |
| 4916 | SUPPL | 2014-07-08 |
| 36582 | SUPPL | 2014-06-10 |
| 4917 | SUPPL | 2014-06-10 |
| 36581 | SUPPL | 2013-02-12 |
| 27376 | SUPPL | 2013-02-12 |
| 4915 | SUPPL | 2011-11-14 |
| 36580 | SUPPL | 2011-03-21 |
| 36579 | SUPPL | 2011-03-21 |
| 36578 | SUPPL | 2011-03-21 |
| 14884 | SUPPL | 2011-03-21 |
| 14882 | SUPPL | 2011-03-21 |
| 14881 | SUPPL | 2011-03-21 |
| 14880 | SUPPL | 2011-03-21 |
| 27375 | SUPPL | 2011-03-08 |
| 27374 | SUPPL | 2011-03-08 |
| 27373 | SUPPL | 2011-03-08 |
| 27372 | SUPPL | 2011-03-08 |
| 4913 | SUPPL | 2011-03-08 |
| 4912 | SUPPL | 2011-03-08 |
| 4910 | SUPPL | 2011-03-08 |
| 14883 | SUPPL | 2009-05-12 |
| 4914 | SUPPL | 2009-05-04 |
| 4911 | SUPPL | 2007-09-06 |
| 44609 | ORIG | 2007-03-16 |
| 4909 | SUPPL | 2005-11-01 |
| 36577 | SUPPL | 2005-10-28 |
| 36576 | SUPPL | 2005-03-30 |
| 27371 | SUPPL | 2005-03-30 |
| 42081 | ORIG | 2002-04-30 |
| 4908 | SUPPL | 2002-04-01 |
| 27370 | ORIG | 2001-05-29 |
| 14879 | ORIG | 2001-05-29 |