ACTIVE SUBSTANCE / INN

LEVETIRACETAM

Brand name(s): KEPPRA XR, Levetiracetam Actavis Group, Matever, SPRITAM, Levetiracetam Sun, Levetiracetam ratiopharm, LEVETIRACETAM, ELEPSIA XR, Keppra, Epixram, Levetiracetam Actavis, Levetiracetam Accord, Levetiracetam Hospira, Levetiracetam Teva, LEVETIRACETAM IN SODIUM CHLORIDE, KEPPRA
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
APPLICATION WITHDRAWN
NDA021505
ANDA090263
ACTIVE SUBSTANCE
Levetiracetam
REGULATORS
FDA · EMA
SPONSORS / MAH
CHARTWELL MOLECULAR, CHINA RESOURCES, HQ SPCLT PHARMA
TOTAL APPLICATIONS
20
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
LEVETIRACETAMANDA078234INVAGEN PHARMSDiscontinued
LEVETIRACETAMANDA090263CHARTWELL MOLECULARPrescription
LEVETIRACETAM IN SODIUM CHLORIDEANDA211356HIKMAPrescription
KEPPRANDA021505UCB INCPrescription
LEVETIRACETAM IN SODIUM CHLORIDENDA202543HQ SPCLT PHARMADiscontinued
ELEPSIA XRNDA204417TRIPOINTDiscontinued
KEPPRA XRNDA022285UCB INCPrescription
LEVETIRACETAMANDA205102CHINA RESOURCESNone (Tentative Approval)
SPRITAMNDA207958APRECIA PHARMSDiscontinued
SPRITAMNDA207958APRECIA PHARMSPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Levetiracetam ActavisActavis Group PTC ehfAuthorised03/10/2011Epilepsy
Levetiracetam TevaTeva B.V.Authorised25/08/2011Epilepsy
Levetiracetam Actavis GroupActavis Group PTC ehfAuthorised04/12/2011Epilepsy
Levetiracetam ratiopharmratiopharm GmbHAuthorised26/08/2011Epilepsy
Levetiracetam SunSun Pharmaceutical Industries Europe B.V.Authorised14/12/2011Epilepsy
MateverPharmathen S.A.Authorised03/10/2011Epilepsy
Levetiracetam HospiraPfizer Europe MA EEIGAuthorised07/01/2014Epilepsy
Levetiracetam AccordAccord Healthcare S.L.U.Authorised03/10/2011Epilepsy
KeppraUCB Pharma SAAuthorised29/09/2000Epilepsy
EpixramNeuraxpharm Pharmaceuticals S.L.Application withdrawnEpilepsy;Epilepsy, Generalized;Myoclonic Epilepsy, Juvenile

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