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ACTIVE SUBSTANCE / INN

BREXPIPRAZOLE

Brand name(s): BREXPIPRAZOLE, REXULTI, Rxulti
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA213683
ANDA213788
ACTIVE SUBSTANCE
Brexpiprazole
REGULATORS
FDA · EMA
SPONSORS / MAH
OTSUKA, ACCORD HLTHCARE INC, AMNEAL
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
BREXPIPRAZOLEANDA213788ACCORD HLTHCARE INCNone (Tentative Approval)
BREXPIPRAZOLEANDA213562AMNEALDiscontinued
BREXPIPRAZOLEANDA213683ALEMBICPrescription
REXULTINDA205422OTSUKAPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
RxultiOtsuka Pharmaceutical Netherlands B.V.Authorised26/07/2018Schizophrenia

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