Application 022416
- Type
- NDA
- Sponsor
- SUNOVION PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | APTIOM | ESLICARBAZEPINE ACETATE | TABLET;ORAL | 200MG | Yes | No |
| 002 | APTIOM | ESLICARBAZEPINE ACETATE | TABLET;ORAL | 400MG | Yes | No |
| 003 | APTIOM | ESLICARBAZEPINE ACETATE | TABLET;ORAL | 600MG | Yes | No |
| 004 | APTIOM | ESLICARBAZEPINE ACETATE | TABLET;ORAL | 800MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022416-001 | APTIOM | ESLICARBAZEPINE ACETATE | 200MG | TABLET / ORAL | AB | RLD | 2013-11-08 |
| N022416-002 | APTIOM | ESLICARBAZEPINE ACETATE | 400MG | TABLET / ORAL | AB | RLD | 2013-11-08 |
| N022416-003 | APTIOM | ESLICARBAZEPINE ACETATE | 600MG | TABLET / ORAL | AB | RLD | 2013-11-08 |
| N022416-004 | APTIOM | ESLICARBAZEPINE ACETATE | 800MG | TABLET / ORAL | AB | RLD, RS | 2013-11-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022416-001 | AB |
| N022416-002 | AB |
| N022416-003 | AB |
| N022416-004 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022416-001 | 9206135 | 2026-04-21 | Drug substance | 2016-05-20 | |
| N022416-001 | 9643929 | 2026-04-21 | Drug product | 2017-06-08 | |
| N022416-001 | 9763954 | 2028-09-13 | U-2123 | 2017-10-10 | |
| N022416-001 | 10912781 | 2028-10-23 | Drug product | 2021-02-10 | |
| N022416-001 | 9566244 | 2028-10-23 | Drug product | 2017-03-08 | |
| N022416-001 | 8372431 | 2030-04-17 | Drug product | ||
| N022416-001 | 9750747 | 2032-08-24 | U-2041 | 2017-09-28 | |
| N022416-001 | 9750747 | 2032-08-24 | U-2121 | 2017-09-28 | |
| N022416-002 | 9206135 | 2026-04-21 | Drug substance | 2016-05-20 | |
| N022416-002 | 9643929 | 2026-04-21 | Drug product | 2017-06-08 | |
| N022416-002 | 9763954 | 2028-09-13 | U-2123 | 2017-10-10 | |
| N022416-002 | 10912781 | 2028-10-23 | Drug product | 2021-02-10 | |
| N022416-002 | 9566244 | 2028-10-23 | Drug product | 2017-03-08 | |
| N022416-002 | 8372431 | 2030-04-17 | Drug product | ||
| N022416-002 | 9750747 | 2032-08-24 | U-2041 | 2017-09-28 | |
| N022416-002 | 9750747 | 2032-08-24 | U-2121 | 2017-09-28 | |
| N022416-003 | 9206135 | 2026-04-21 | Drug substance | 2016-05-20 | |
| N022416-003 | 9643929 | 2026-04-21 | Drug product | 2017-06-08 | |
| N022416-003 | 9763954 | 2028-09-13 | U-2123 | 2017-10-10 | |
| N022416-003 | 10912781 | 2028-10-23 | Drug product | 2021-02-10 | |
| N022416-003 | 9566244 | 2028-10-23 | Drug product | 2017-03-08 | |
| N022416-003 | 8372431 | 2030-04-17 | Drug product | ||
| N022416-003 | 9750747 | 2032-08-24 | U-2041 | 2017-09-28 | |
| N022416-003 | 9750747 | 2032-08-24 | U-2121 | 2017-09-28 | |
| N022416-004 | 9206135 | 2026-04-21 | Drug substance | 2016-05-20 | |
| N022416-004 | 9643929 | 2026-04-21 | Drug product | 2017-06-08 | |
| N022416-004 | 9763954 | 2028-09-13 | U-2123 | 2017-10-10 | |
| N022416-004 | 10912781 | 2028-10-23 | Drug product | 2021-02-10 | |
| N022416-004 | 9566244 | 2028-10-23 | Drug product | 2017-03-08 | |
| N022416-004 | 8372431 | 2030-04-17 | Drug product | ||
| N022416-004 | 9750747 | 2032-08-24 | U-2041 | 2017-09-28 | |
| N022416-004 | 9750747 | 2032-08-24 | U-2121 | 2017-09-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N022416-001 | APTIOM | 200MG | TABLET / ORAL | AB | RLD | 2013-11-08 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022416-002 | APTIOM | 400MG | TABLET / ORAL | AB | RLD | 2013-11-08 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022416-003 | APTIOM | 600MG | TABLET / ORAL | AB | RLD | 2013-11-08 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022416-004 | APTIOM | 800MG | TABLET / ORAL | AB | RLD, RS | 2013-11-08 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022416-001 | APTIOM | 200MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022416-002 | APTIOM | 400MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022416-003 | APTIOM | 600MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022416-004 | APTIOM | 800MG | TABLET / ORAL | AB | RLD, RS | 2013-11-08 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022416-001 | APTIOM | 200MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022416-002 | APTIOM | 400MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022416-003 | APTIOM | 600MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022416-004 | APTIOM | 800MG | TABLET / ORAL | AB | RLD, RS | 2013-11-08 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022416-001 | APTIOM | 200MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022416-002 | APTIOM | 400MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022416-003 | APTIOM | 600MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022416-004 | APTIOM | 800MG | TABLET / ORAL | AB | RLD, RS | 2013-11-08 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022416-001 | APTIOM | 200MG | TABLET / ORAL | AB | RLD | 2013-11-08 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022416-002 | APTIOM | 400MG | TABLET / ORAL | AB | RLD | 2013-11-08 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022416-003 | APTIOM | 600MG | TABLET / ORAL | AB | RLD | 2013-11-08 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022416-004 | APTIOM | 800MG | TABLET / ORAL | AB | RLD, RS | 2013-11-08 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022416-001 | APTIOM | 200MG | TABLET / ORAL | AB | RLD | 2013-11-08 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022416-002 | APTIOM | 400MG | TABLET / ORAL | AB | RLD | 2013-11-08 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022416-003 | APTIOM | 600MG | TABLET / ORAL | AB | RLD | 2013-11-08 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022416-004 | APTIOM | 800MG | TABLET / ORAL | AB | RLD, RS | 2013-11-08 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022416-001 | APTIOM | 200MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022416-002 | APTIOM | 400MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022416-003 | APTIOM | 600MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022416-004 | APTIOM | 800MG | TABLET / ORAL | AB | RLD, RS | 2013-11-08 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022416-001 | APTIOM | 200MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022416-002 | APTIOM | 400MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022416-003 | APTIOM | 600MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022416-004 | APTIOM | 800MG | TABLET / ORAL | AB | RLD, RS | 2013-11-08 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022416-001 | APTIOM | 200MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022416-002 | APTIOM | 400MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022416-003 | APTIOM | 600MG | TABLET / ORAL | AB | RLD | 2013-11-08 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022416-004 | APTIOM | 800MG | TABLET / ORAL | AB | RLD, RS | 2013-11-08 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022416-001 | APTIOM | 200MG | TABLET / ORAL | AB | RLD | 2013-11-08 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022416-002 | APTIOM | 400MG | TABLET / ORAL | AB | RLD | 2013-11-08 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022416-003 | APTIOM | 600MG | TABLET / ORAL | AB | RLD | 2013-11-08 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022416-004 | APTIOM | 800MG | TABLET / ORAL | AB | RLD, RS | 2013-11-08 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N022416-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022416-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022416-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022416-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022416-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022416-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022416-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022416-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022416-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022416-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022416-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022416-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022416-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022416-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022416-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022416-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022416-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022416-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022416-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022416-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022416-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022416-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022416-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022416-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022416-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022416-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022416-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022416-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022416-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022416-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022416-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022416-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022416-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022416-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022416-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022416-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022416-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022416-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022416-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022416-004 | AB | 1 | d8e5a09893c0… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N022416-001 | 9206135 | 2026-04-21 | Drug substance | 2016-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-001 | 9643929 | 2026-04-21 | Drug product | 2017-06-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-001 | 9763954 | 2028-09-13 | U-2123 | 2017-10-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-001 | 10912781 | 2028-10-23 | Drug product | 2021-02-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-001 | 9566244 | 2028-10-23 | Drug product | 2017-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-001 | 8372431 | 2030-04-17 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022416-001 | 9750747 | 2032-08-24 | U-2041 | 2017-09-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-001 | 9750747 | 2032-08-24 | U-2121 | 2017-09-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-002 | 9206135 | 2026-04-21 | Drug substance | 2016-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-002 | 9643929 | 2026-04-21 | Drug product | 2017-06-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-002 | 9763954 | 2028-09-13 | U-2123 | 2017-10-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-002 | 10912781 | 2028-10-23 | Drug product | 2021-02-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-002 | 9566244 | 2028-10-23 | Drug product | 2017-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-002 | 8372431 | 2030-04-17 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022416-002 | 9750747 | 2032-08-24 | U-2121 | 2017-09-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-002 | 9750747 | 2032-08-24 | U-2041 | 2017-09-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-003 | 9206135 | 2026-04-21 | Drug substance | 2016-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-003 | 9643929 | 2026-04-21 | Drug product | 2017-06-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-003 | 9763954 | 2028-09-13 | U-2123 | 2017-10-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-003 | 10912781 | 2028-10-23 | Drug product | 2021-02-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-003 | 9566244 | 2028-10-23 | Drug product | 2017-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-003 | 8372431 | 2030-04-17 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022416-003 | 9750747 | 2032-08-24 | U-2121 | 2017-09-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-003 | 9750747 | 2032-08-24 | U-2041 | 2017-09-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-004 | 9206135 | 2026-04-21 | Drug substance | 2016-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-004 | 9643929 | 2026-04-21 | Drug product | 2017-06-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-004 | 9763954 | 2028-09-13 | U-2123 | 2017-10-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-004 | 10912781 | 2028-10-23 | Drug product | 2021-02-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-004 | 9566244 | 2028-10-23 | Drug product | 2017-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-004 | 8372431 | 2030-04-17 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022416-004 | 9750747 | 2032-08-24 | U-2041 | 2017-09-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022416-004 | 9750747 | 2032-08-24 | U-2121 | 2017-09-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022416-001 | 9206135 | 2026-04-21 | Drug substance | 2016-05-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022416-001 | 9643929 | 2026-04-21 | Drug product | 2017-06-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022416-001 | 9763954 | 2028-09-13 | U-2123 | 2017-10-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022416-001 | 10912781 | 2028-10-23 | Drug product | 2021-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022416-001 | 9566244 | 2028-10-23 | Drug product | 2017-03-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022416-001 | 8372431 | 2030-04-17 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022416-001 | 9750747 | 2032-08-24 | U-2041 | 2017-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022416-001 | 9750747 | 2032-08-24 | U-2121 | 2017-09-28 | 011fe1cb6892… |
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 |
|---|---|---|---|---|---|---|
| Aptiom | ESLICARBAZEPINE ACETATE | Sumitomo Pharma America, Inc. | 3d0c9554-eaeb-4694-8089-00133fcadce3 | 2023-11-10 | Warnings, Adverse reactions | 022416 NDA022416 63402-248 63402-208 63402-204 63402-202 63402-206 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63402-202 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-202 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals | NDA | Current |
| 63402-202 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-204 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-204 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals | NDA | Current |
| 63402-204 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-206 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-206 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals | NDA | Current |
| 63402-206 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-208 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-208 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals | NDA | Current |
| 63402-208 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-248 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-248 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals | NDA | Current |
| 63402-248 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79550 | SUPPL | 2024-09-06 |
| 79547 | SUPPL | 2024-09-06 |
| 58027 | SUPPL | 2019-03-18 |
| 58026 | SUPPL | 2019-03-18 |
| 58012 | SUPPL | 2019-03-18 |
| 49814 | SUPPL | 2017-09-20 |
| 49733 | SUPPL | 2017-09-14 |
| 47510 | SUPPL | 2017-03-08 |
| 29702 | SUPPL | 2015-09-01 |
| 38676 | SUPPL | 2015-08-28 |
| 24301 | ORIG | 2013-12-20 |
| 22016 | ORIG | 2013-12-20 |
| 17559 | ORIG | 2013-11-15 |
| 29701 | ORIG | 2013-11-13 |
| 52482 | SUPPL | 1900-01-01 |
| 52481 | SUPPL | 1900-01-01 |
| 52480 | SUPPL | 1900-01-01 |