ACTIVE SUBSTANCE / INN

ARIPIPRAZOLE

Brand name(s): ABILIFY ASIMTUFII, ABILIFY MAINTENA KIT, Abilify MyCite, MEZOFY, Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen), Abilify Maintena, Aripiprazole Mylan, OPIPZA, ABILIFY MYCITE KIT, ARIPIPRAZOLE, Aripiprazole Sandoz, Abilify, Asimtufii, Aripiprazole Zentiva, Aripiprazole Accord, ABILIFY
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
APPLICATION WITHDRAWN
NDA211448
ANDA202102
ACTIVE SUBSTANCE
Aripiprazole
REGULATORS
FDA · EMA
SPONSORS / MAH
Generics (UK) Limited, PHARMTAK INC, OTSUKA
TOTAL APPLICATIONS
20
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ARIPIPRAZOLEANDA202102ALEMBICPrescription
OPIPZANDA216655XIAMEN LP PHARM COPrescription
ABILIFYNDA021729OTSUKADiscontinued
ARIPIPRAZOLEANDA091279AIPING PHARM INCDiscontinued
ARIPIPRAZOLEANDA208260PHARMTAK INCNone (Tentative Approval)
MEZOFYNDA211448CMG PHARM CO LTDDiscontinued
ABILIFYNDA021436OTSUKAPrescription
ABILIFY MYCITE KITNDA207202OTSUKADiscontinued
ABILIFY MAINTENA KITNDA202971OTSUKA PHARM CO LTDPrescription
ABILIFY ASIMTUFIINDA217006OTSUKAPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)Mylan Pharmaceuticals LimitedAuthorised30/06/2015Schizophrenia;Bipolar Disorder
Aripiprazole ZentivaZentiva, k.s.Authorised25/06/2015Schizophrenia;Bipolar Disorder
AbilifyOtsuka Pharmaceutical Netherlands B.V.Authorised04/06/2004Schizophrenia;Bipolar Disorder
Abilify MaintenaOtsuka Pharmaceutical Netherlands B.V.Authorised14/11/2013Schizophrenia
Aripiprazole SandozSandoz GmbHAuthorised20/08/2015Schizophrenia;Bipolar Disorder
Aripiprazole AccordAccord Healthcare S.L.U.Authorised15/11/2015Schizophrenia;Bipolar Disorder
AsimtufiiOtsuka Pharmaceutical Netherlands B.V.Application withdrawnSchizophrenia
Abilify MyCiteOtsuka Pharmaceutical Netherlands B.V.Application withdrawnSchizophrenia;Bipolar Disorder
Aripiprazole MylanMylan S.A.S.Application withdrawnSchizophrenia
Aripiprazole MylanGenerics (UK) LimitedApplication withdrawnSchizophrenia;Bipolar Disorder

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