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ACTIVE SUBSTANCE / INN

ESLICARBAZEPINE ACETATE

Brand name(s): APTIOM, Zebinix, ESLICARBAZEPINE ACETATE, Exalief
FDA LISTED
EMA LISTED
PRESCRIPTION
LAPSED
AUTHORISED
NDA022416
ANDA211186
ACTIVE SUBSTANCE
Eslicarbazepine Acetate
REGULATORS
FDA · EMA
SPONSORS / MAH
SUMITOMO PHARMA AM, AUROBINDO PHARMA LTD, BIAL - Portela & Ca, S.A.
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ESLICARBAZEPINE ACETATEANDA211186HETERO LABS LTD VPrescription
ESLICARBAZEPINE ACETATEANDA216481AUROBINDO PHARMA LTDNone (Tentative Approval)
APTIOMNDA022416SUMITOMO PHARMA AMPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ZebinixBIAL - Portela & Ca, S.A.Authorised21/04/2009Epilepsy
ExaliefBIAL - Portela Ca, S.A.Lapsed21/04/2009Epilepsy

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