eslicarbazepine Oral Tablet
- Brand(s)
- Aptiom
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Sunovion Pharmaceuticals Inc. (2015-09-04)
- Oldest Current Product
- 2014-04-07
- License(s)
- NDA
- RxNORM
- ORAL TABLET\ESLICARBAZEPINE
- FDAOB
- ORAL\TABLET\ESLICARBAZEPINE ACETATE
- SPL Active
- ORAL\TABLET\ESLICARBAZEPINE ACETATE
- SPL Moiety
- ORAL\TABLET\ESLICARBAZEPINE
product(s) by strength(s)
eslicarbazepine acetate 200 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 634020202 | Aptiom | NDA | Sunovion Pharmaceuticals Inc. | 2014-04-07 | ESLICARBAZEPINE ACETATE | ORAL | TABLET | NDA022416 | 3d0c9554-eaeb-4694-8089-00133fcadce3 |
eslicarbazepine acetate 400 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 634020204 | Aptiom | NDA | Sunovion Pharmaceuticals Inc. | 2014-04-07 | ESLICARBAZEPINE ACETATE | ORAL | TABLET | NDA022416 | 3d0c9554-eaeb-4694-8089-00133fcadce3 |
eslicarbazepine acetate 600 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 634020206 | Aptiom | NDA | Sunovion Pharmaceuticals Inc. | 2014-04-07 | ESLICARBAZEPINE ACETATE | ORAL | TABLET | NDA022416 | 3d0c9554-eaeb-4694-8089-00133fcadce3 |
eslicarbazepine acetate 800 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 634020208 | Aptiom | NDA | Sunovion Pharmaceuticals Inc. | 2014-04-07 | ESLICARBAZEPINE ACETATE | ORAL | TABLET | NDA022416 | 3d0c9554-eaeb-4694-8089-00133fcadce3 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA022416 | APTIOM | SUNOVION PHARMACEUTICALS INC | 2013-11-08 | p8372431, SUBSTANCE p5753646, APPROVED INDICATIONS: APTIOM (ESLICARBAZEPINE ACETATE) IS INDICATED AS ADJUNCTIVE TREATMENT OF PARTIAL-ONSET SEIZURES AND APPROVED IN PATIENTS WITH EPILEPSY. PATENT CLAIMS: IN A METHOD OF TREATING A SUBJECT AFFLICTED WITH EPILEPSY/ MONOTHERAPY OR ADJUNCTIVE THERAPY FOR TREATMENT OF PARTIAL-ONSET SEIZURES AND APPROVED IN PATIENTS WITH EPILEPSY, SUBSTANCE | 1600MG DAILY FOR PATIENTS ON ADJUNCTIVE THERAPY WHO DID NOT ACHIEVE A SATISFACTORY RESPONSE ON 1200MG DAILY DOSE [2018-08-27] FOR THE ADDITION OF THE INDICATION FOR MONOTHERAPY TREATMENT IN PARTIAL-ONSET SEIZURES IN ADULTS. [2018-08-27] NEW CHEMICAL ENTITY [2018-11-08] | NDA022416_001, NDA022416_002, NDA022416_003, NDA022416_004 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA022416_001 | RX | ESLICARBAZEPINE ACETATE (200MG) | ORAL | TABLET | False | 2013-11-08 | APTIOM |
| 2 | NDA022416_002 | RX | ESLICARBAZEPINE ACETATE (400MG) | ORAL | TABLET | False | 2013-11-08 | APTIOM |
| 3 | NDA022416_003 | RX | ESLICARBAZEPINE ACETATE (600MG) | ORAL | TABLET | False | 2013-11-08 | APTIOM |
| 4 | NDA022416_004 | RX | ESLICARBAZEPINE ACETATE (800MG) | ORAL | TABLET | True | 2013-11-08 | APTIOM |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p5753646 (view patent) | 2016-06-27 | NDA022416 |
| 2 | p8372431 (view patent) | 2030-04-17 | NDA022416 |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 3d0c9554-eaeb-4694-8089-00133fcadce3 (view SPL) | These highlights do not include all the information needed to use APTIOM safely and effectively. See full prescribing information for APTIOM. APTIOM (eslicarbazepine acetate) tablets, for oral useInitial U.S. Approval: 2013 | prescription | Human Prescription | Sunovion Pharmaceuticals Inc. | 2015-09-04 | 6 | 634020202, 634020204, 634020206, 634020208, 634020248 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII