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ACTIVE SUBSTANCE / INN

VORTIOXETINE

Brand name(s): VORTIOXETINE HYDROBROMIDE, VORTIOXETINE, Brintellix
FDA LISTED
EMA LISTED
AUTHORISED
NONE (TENTATIVE APPROVAL)
Depressive Disorder, Major
ANDA211165
ACTIVE SUBSTANCE
Vortioxetine
REGULATORS
FDA · EMA
SPONSORS / MAH
MACLEODS PHARMACEUTICALS LTD, ALKEM LABS LTD, H. Lundbeck A/S
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
VORTIOXETINEANDA211089ALKEM LABS LTDNone (Tentative Approval)
VORTIOXETINE HYDROBROMIDEANDA211165MACLEODS PHARMACEUTICALS LTDNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
BrintellixH. Lundbeck A/SAuthorised18/12/2013Depressive Disorder, Major

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