Application 021014
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRILEPTAL | OXCARBAZEPINE | TABLET;ORAL | 150MG | Yes | No |
| 002 | TRILEPTAL | OXCARBAZEPINE | TABLET;ORAL | 300MG | Yes | No |
| 003 | TRILEPTAL | OXCARBAZEPINE | TABLET;ORAL | 600MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021014-001 | TRILEPTAL | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | RLD | 2000-01-14 |
| N021014-002 | TRILEPTAL | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | RLD | 2000-01-14 |
| N021014-003 | TRILEPTAL | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | RLD, RS | 2000-01-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021014-001 | AB |
| N021014-002 | AB |
| N021014-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N021014-001 | TRILEPTAL | 150MG | TABLET / ORAL | AB | RLD | 2000-01-14 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N021014-002 | TRILEPTAL | 300MG | TABLET / ORAL | AB | RLD | 2000-01-14 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N021014-003 | TRILEPTAL | 600MG | TABLET / ORAL | AB | RLD, RS | 2000-01-14 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N021014-001 | TRILEPTAL | 150MG | TABLET / ORAL | AB | RLD | 2000-01-14 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021014-002 | TRILEPTAL | 300MG | TABLET / ORAL | AB | RLD | 2000-01-14 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021014-003 | TRILEPTAL | 600MG | TABLET / ORAL | AB | RLD, RS | 2000-01-14 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021014-001 | TRILEPTAL | 150MG | TABLET / ORAL | AB | RLD | 2000-01-14 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021014-002 | TRILEPTAL | 300MG | TABLET / ORAL | AB | RLD | 2000-01-14 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021014-003 | TRILEPTAL | 600MG | TABLET / ORAL | AB | RLD, RS | 2000-01-14 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021014-001 | TRILEPTAL | 150MG | TABLET / ORAL | AB | RLD | 2000-01-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021014-002 | TRILEPTAL | 300MG | TABLET / ORAL | AB | RLD | 2000-01-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021014-003 | TRILEPTAL | 600MG | TABLET / ORAL | AB | RLD, RS | 2000-01-14 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021014-001 | TRILEPTAL | 150MG | TABLET / ORAL | AB | RLD | 2000-01-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021014-002 | TRILEPTAL | 300MG | TABLET / ORAL | AB | RLD | 2000-01-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021014-003 | TRILEPTAL | 600MG | TABLET / ORAL | AB | RLD, RS | 2000-01-14 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021014-001 | TRILEPTAL | 150MG | TABLET / ORAL | AB | RLD | 2000-01-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021014-002 | TRILEPTAL | 300MG | TABLET / ORAL | AB | RLD | 2000-01-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021014-003 | TRILEPTAL | 600MG | TABLET / ORAL | AB | RLD, RS | 2000-01-14 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021014-001 | TRILEPTAL | 150MG | TABLET / ORAL | AB | RLD | 2000-01-14 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021014-002 | TRILEPTAL | 300MG | TABLET / ORAL | AB | RLD | 2000-01-14 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021014-003 | TRILEPTAL | 600MG | TABLET / ORAL | AB | RLD, RS | 2000-01-14 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021014-001 | TRILEPTAL | 150MG | TABLET / ORAL | AB | RLD | 2000-01-14 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021014-002 | TRILEPTAL | 300MG | TABLET / ORAL | AB | RLD | 2000-01-14 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021014-003 | TRILEPTAL | 600MG | TABLET / ORAL | AB | RLD, RS | 2000-01-14 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021014-001 | TRILEPTAL | 150MG | TABLET / ORAL | AB | RLD | 2000-01-14 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021014-002 | TRILEPTAL | 300MG | TABLET / ORAL | AB | RLD | 2000-01-14 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021014-003 | TRILEPTAL | 600MG | TABLET / ORAL | AB | RLD, RS | 2000-01-14 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021014-001 | TRILEPTAL | 150MG | TABLET / ORAL | AB | RLD | 2000-01-14 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021014-002 | TRILEPTAL | 300MG | TABLET / ORAL | AB | RLD | 2000-01-14 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021014-003 | TRILEPTAL | 600MG | TABLET / ORAL | AB | RLD, RS | 2000-01-14 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021014-001 | TRILEPTAL | 150MG | TABLET / ORAL | AB | RLD | 2000-01-14 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021014-002 | TRILEPTAL | 300MG | TABLET / ORAL | AB | RLD | 2000-01-14 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021014-003 | TRILEPTAL | 600MG | TABLET / ORAL | AB | RLD, RS | 2000-01-14 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021014-001 | TRILEPTAL | 150MG | TABLET / ORAL | AB | RLD | 2000-01-14 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021014-002 | TRILEPTAL | 300MG | TABLET / ORAL | AB | RLD | 2000-01-14 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021014-003 | TRILEPTAL | 600MG | TABLET / ORAL | AB | RLD, RS | 2000-01-14 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021014-001 | TRILEPTAL | 150MG | TABLET / ORAL | AB | RLD | 2000-01-14 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021014-002 | TRILEPTAL | 300MG | TABLET / ORAL | AB | RLD | 2000-01-14 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021014-003 | TRILEPTAL | 600MG | TABLET / ORAL | AB | RLD, RS | 2000-01-14 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021014-001 | TRILEPTAL | 150MG | TABLET / ORAL | AB | RLD | 2000-01-14 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N021014-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N021014-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N021014-003 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N021014-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021014-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021014-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021014-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021014-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021014-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021014-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021014-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021014-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021014-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021014-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021014-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021014-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021014-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021014-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021014-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021014-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021014-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021014-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021014-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021014-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021014-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021014-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021014-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021014-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021014-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021014-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021014-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021014-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021014-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021014-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021014-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021014-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021014-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021014-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021014-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021014-001 | AB | 1 | 79d66fd596c7… |
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 | Umedica Laboratories USA Inc. | e46d4654-76bc-4c33-ac2b-e89ae11b7697 | 2026-10-23 | Warnings, Adverse reactions | OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | Cardinal Health 107, LLC | 4ebcb0e5-1c93-4b3f-8749-6835c56afce5 | 2026-08-12 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | REMEDYREPACK INC. | a2032bcc-2da5-45e5-aa3f-ddbf50909df8 | 2026-08-05 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | REMEDYREPACK INC. | a90cd1f1-5258-4b0e-92fd-c4cebe47772b | 2026-08-04 | Warnings, Adverse reactions | OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | ffc8d10c-0049-4fe5-beb8-79cc6a197ede | 2026-07-23 | Warnings, Adverse reactions | OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | b571ee0f-3c2a-4c55-9c2b-e00014e2ec7a | 2026-07-21 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | Cardinal Health 107, LLC | 3e0f8d9f-7659-4524-8f93-6200314356c8 | 2026-07-21 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | ANI Pharmaceuticals, Inc. | 867eaf99-3e31-4f75-bfae-2898804d956d | 2026-07-13 | Warnings, Adverse reactions | OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | 85a9bdee-4d10-4097-ae3d-0bf8d844a11b | 2026-07-08 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | American Health Packaging | c0f9df3f-280e-4394-8d7e-ad04803b2635 | 2026-07-02 | Warnings, Adverse reactions | OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | Major Pharmaceuticals | b1d54def-057d-4608-bc8f-1d967ac3ec91 | 2026-06-15 | Warnings, Adverse reactions | OXCARBAZEPINE |
| oxcarbazepine | OXCARBAZEPINE | Zydus Lifesciences Limited | e23d8a74-b47b-462a-b09c-90bdd58a032e | 2026-06-13 | Warnings, Adverse reactions | OXCARBAZEPINE |
| oxcarbazepine | OXCARBAZEPINE | Zydus Pharmaceuticals (USA) Inc. | 5048dc87-2d89-434d-be51-4a97b0ce0601 | 2026-06-13 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | REMEDYREPACK INC. | c7718f8b-63e2-40b9-b519-e687cfc2cacf | 2026-06-11 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | REMEDYREPACK INC. | 188a48ad-c412-416a-b15b-de5f232740a2 | 2026-06-11 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | REMEDYREPACK INC. | 0abe9478-4084-286d-e063-6294a90a9ba7 | 2026-06-10 | Warnings, Adverse reactions | OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | fcf5044a-8cfd-47d5-9f47-8f6674843c24 | 2026-06-08 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | Sun Pharmaceutical Industries, Inc. | 7ecd5eef-46f4-407f-9b63-ba65adb3eced | 2026-06-03 | Warnings, Adverse reactions | OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | Camber Pharmaceuticals, Inc. | a18f591b-587e-4769-8ac2-9cfba0b82526 | 2026-05-22 | Warnings, Adverse reactions | OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | ASCLEMED USA INC. | c42b2cb2-8b45-488b-bf63-81909a1f06cb | 2026-05-19 | 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 |
|---|---|---|---|---|---|
| 0078-0337 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0337 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0337 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0337 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0337 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0337 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0337 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0456 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0456 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0456 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0456 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0456 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0456 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0456 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0457 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0457 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0457 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0457 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0457 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0457 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0457 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 55289-007 | Trileptal | oxcarbazepine | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-007 | Trileptal | oxcarbazepine | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-007 | Trileptal | oxcarbazepine | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-007 | Trileptal | oxcarbazepine | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 70518-1300 | Trileptal | oxcarbazepine | REMEDYREPACK INC. | NDA | Current |
| 70518-1300 | Trileptal | oxcarbazepine | REMEDYREPACK INC. | NDA | Current |
| 70518-1349 | Trileptal | oxcarbazepine | REMEDYREPACK INC. | NDA | Current |
| 70518-1349 | Trileptal | oxcarbazepine | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83527 | SUPPL | 2025-09-26 |
| 83526 | SUPPL | 2025-09-26 |
| 83435 | SUPPL | 2025-09-25 |
| 81207 | SUPPL | 2025-02-11 |
| 81206 | SUPPL | 2025-02-11 |
| 79543 | SUPPL | 2024-09-05 |
| 79541 | SUPPL | 2024-09-05 |
| 57415 | SUPPL | 2019-02-04 |
| 57136 | SUPPL | 2019-01-08 |
| 53501 | SUPPL | 2018-03-28 |
| 53242 | SUPPL | 2018-03-23 |
| 53236 | SUPPL | 2018-03-23 |
| 50489 | SUPPL | 2017-11-27 |
| 50460 | SUPPL | 2017-11-20 |
| 47726 | SUPPL | 2017-03-28 |
| 47668 | SUPPL | 2017-03-24 |
| 35890 | SUPPL | 2014-07-08 |
| 4044 | SUPPL | 2014-07-08 |
| 14165 | SUPPL | 2014-06-10 |
| 4045 | SUPPL | 2014-06-10 |
| 35889 | SUPPL | 2013-02-12 |
| 4043 | SUPPL | 2013-02-12 |
| 26490 | SUPPL | 2011-11-14 |
| 35888 | SUPPL | 2011-03-21 |
| 35887 | SUPPL | 2011-03-21 |
| 35885 | SUPPL | 2011-03-21 |
| 35884 | SUPPL | 2011-03-21 |
| 35883 | SUPPL | 2011-03-21 |
| 14164 | SUPPL | 2011-03-21 |
| 14163 | SUPPL | 2011-03-21 |
| 26489 | SUPPL | 2011-03-08 |
| 26487 | SUPPL | 2011-03-08 |
| 26486 | SUPPL | 2011-03-08 |
| 4042 | SUPPL | 2011-03-08 |
| 4041 | SUPPL | 2011-03-08 |
| 4040 | SUPPL | 2011-03-08 |
| 4038 | SUPPL | 2011-03-08 |
| 35886 | SUPPL | 2009-05-12 |
| 26488 | SUPPL | 2009-05-04 |
| 4039 | SUPPL | 2007-09-06 |
| 24144 | ORIG | 2007-03-16 |
| 41877 | SUPPL | 2006-05-31 |
| 26485 | SUPPL | 2005-11-18 |
| 26484 | SUPPL | 2005-11-01 |
| 14162 | SUPPL | 2005-10-28 |
| 14161 | SUPPL | 2005-03-30 |
| 4037 | SUPPL | 2005-03-30 |
| 35882 | SUPPL | 2003-08-15 |
| 4034 | SUPPL | 2003-08-15 |
| 4036 | SUPPL | 2003-04-15 |
| 4035 | SUPPL | 2002-04-01 |
| 41876 | ORIG | 2002-02-28 |
| 35881 | ORIG | 1999-01-10 |
| 26483 | ORIG | 1999-01-10 |
| 52101 | SUPPL | 1900-01-01 |
| 52099 | SUPPL | 1900-01-01 |
| 52096 | SUPPL | 1900-01-01 |
| 52094 | SUPPL | 1900-01-01 |