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 | 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 |
|---|---|---|---|---|---|
| 0078-0337 | 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 |