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ACTIVE SUBSTANCE / INN

TEMOZOLOMIDE

Brand name(s): Temozolomide Hexal, Temozolomide Sun, TEMOZOLOMIDE, Temozolomide Sandoz, Temomedac, Kizfizo, Temodal, Temozolomide Accord, TEMODAR, Temozolomide Teva
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
WITHDRAWN
ANDA203490
Glioma
ACTIVE SUBSTANCE
Temozolomide
REGULATORS
FDA · EMA
SPONSORS / MAH
Hexal AG, Sandoz GmbH, Sun Pharmaceutical Industries Europe B.V.
TOTAL APPLICATIONS
12
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TEMOZOLOMIDEANDA203691AMNEAL PHARMSPrescription
TEMOZOLOMIDEANDA203490ANI PHARMSDiscontinued
TEMODARNDA021029MERCK SHARP DOHMEDiscontinued
TEMODARNDA022277MERCK SHARP DOHMEPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
KizfizoORPHELIA PharmaRefusedNeuroblastoma
TemodalMerck Sharp & Dohme B.V. Authorised26/01/1999Glioma
Temozolomide SunSun Pharmaceutical Industries Europe B.V.Authorised13/07/2011Glioma
Temozolomide AccordAccord Healthcare S.L.U.Authorised15/03/2010Glioma
Temozolomide TevaTeva B.V. Authorised28/01/2010Glioma
Temozolomide SandozSandoz GmbHWithdrawn15/03/2010Glioma
Temozolomide HexalHexal AGWithdrawn15/03/2010Glioma
Temomedacmedac Gesellschaft für klinische Spezialpräparate mbHAuthorised25/01/2010Glioma

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