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ACTIVE SUBSTANCE / INN

OLANZAPINE

Brand name(s): Olazax, ZYPREXA, Zalasta, SYMBYAX, Olanzapine Glenmark, Olanzapine Cipla (previously Olanzapine Neopharma), Olazax Disperzi, Olanzapine Teva, ZYPREXA ZYDIS, Zypadhera, OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, Olanzapine Apotex, Olanzapine Glenmark Europe, OLANZAPINE, Olanzapine Viatris (previously Olanzapine Mylan), Olansek, Zyprexa Velotab, Zyprexa, LYBALVI
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
WITHDRAWN
NDA021520
NDA021253
ACTIVE SUBSTANCE
Olanzapine
REGULATORS
FDA · EMA
SPONSORS / MAH
ALKERMES INC, CHEPLAPHARM, SUN PHARM INDS
TOTAL APPLICATIONS
21
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
OLANZAPINEANDA091415TORRENTPrescription
LYBALVINDA213378ALKERMES INCPrescription
OLANZAPINEANDA090881SUN PHARM INDSDiscontinued
ZYPREXANDA021253CHEPLAPHARMPrescription
OLANZAPINE AND FLUOXETINE HYDROCHLORIDEANDA077742PH HEALTHPrescription
OLANZAPINEANDA077993ROXANENone (Tentative Approval)
ZYPREXA ZYDISNDA021086CHEPLAPHARMPrescription
SYMBYAXNDA021520LILLYDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ZyprexaCHEPLAPHARM Registration GmbHAuthorised27/09/1996Schizophrenia;Bipolar Disorder
ZypadheraCHEPLAPHARM Registration GmbHAuthorised19/11/2008Schizophrenia
Olanzapine Viatris (previously Olanzapine Mylan)Viatris LimitedAuthorised06/10/2008Schizophrenia;Bipolar Disorder
Olanzapine ApotexApotex Europe BVWithdrawn10/06/2010Schizophrenia;Bipolar Disorder
Olanzapine TevaTeva B.V. Authorised12/12/2007Schizophrenia;Bipolar Disorder
Zyprexa VelotabCHEPLAPHARM Registration GmbHAuthorised03/02/2000Schizophrenia;Bipolar Disorder
ZalastaKrkaAuthorised27/09/2007Schizophrenia;Bipolar Disorder
Olanzapine Glenmark EuropeGlenmark Arzneimittel GmbHAuthorised03/12/2009Schizophrenia;Bipolar Disorder
Olanzapine GlenmarkGlenmark Arzneimittel GmbHAuthorised03/12/2009Schizophrenia;Bipolar Disorder
OlazaxGlenmark Pharmaceuticals s.r.o. Authorised11/12/2009Schizophrenia;Bipolar Disorder

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