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ACTIVE SUBSTANCE / INN

RANOLAZINE

Brand name(s): RANOLAZINE, RANEXA, ASPRUZYO SPRINKLE, Ranexa (previously Latixa)
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA021526
NDA216018
ACTIVE SUBSTANCE
Ranolazine
REGULATORS
FDA · EMA
SPONSORS / MAH
TEVA PHARMS, Menarini International Operations Luxembourg S.A. (MIOL), SPIL
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
RANOLAZINEANDA201046CHARTWELL RXPrescription
RANOLAZINEANDA210482ANI PHARMSDiscontinued
ASPRUZYO SPRINKLENDA216018SPILDiscontinued
RANOLAZINEANDA208174TEVA PHARMSNone (Tentative Approval)
RANEXANDA021526MENARINI INTLDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Ranexa (previously Latixa)Menarini International Operations Luxembourg S.A. (MIOL)Authorised08/07/2008Angina Pectoris

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