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)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634020202AptiomNDASunovion Pharmaceuticals Inc.2014-04-07ESLICARBAZEPINE ACETATEORALTABLETNDA0224163d0c9554-eaeb-4694-8089-00133fcadce3

eslicarbazepine acetate 400 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634020204AptiomNDASunovion Pharmaceuticals Inc.2014-04-07ESLICARBAZEPINE ACETATEORALTABLETNDA0224163d0c9554-eaeb-4694-8089-00133fcadce3

eslicarbazepine acetate 600 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634020206AptiomNDASunovion Pharmaceuticals Inc.2014-04-07ESLICARBAZEPINE ACETATEORALTABLETNDA0224163d0c9554-eaeb-4694-8089-00133fcadce3

eslicarbazepine acetate 800 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634020208AptiomNDASunovion Pharmaceuticals Inc.2014-04-07ESLICARBAZEPINE ACETATEORALTABLETNDA0224163d0c9554-eaeb-4694-8089-00133fcadce3

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022416APTIOMSUNOVION PHARMACEUTICALS INC2013-11-08p8372431, 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)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022416_001RXESLICARBAZEPINE ACETATE (200MG)ORALTABLETFalse2013-11-08APTIOM
2NDA022416_002RXESLICARBAZEPINE ACETATE (400MG)ORALTABLETFalse2013-11-08APTIOM
3NDA022416_003RXESLICARBAZEPINE ACETATE (600MG)ORALTABLETFalse2013-11-08APTIOM
4NDA022416_004RXESLICARBAZEPINE ACETATE (800MG)ORALTABLETTrue2013-11-08APTIOM

patent(s)

#idexpiration dateapplication(s)
1p5753646 (view patent)2016-06-27NDA022416
2p8372431 (view patent)2030-04-17NDA022416

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
13d0c9554-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: 2013prescriptionHuman PrescriptionSunovion Pharmaceuticals Inc.2015-09-046634020202, 634020204, 634020206, 634020208, 634020248

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII