ACTIVE SUBSTANCE / INN

DEUTETRABENAZINE

Brand name(s): Austedo, AUSTEDO, DEUTETRABENAZINE, AUSTEDO XR
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA216354
Tardive Dyskinesia
ACTIVE SUBSTANCE
Deutetrabenazine
REGULATORS
FDA · EMA
SPONSORS / MAH
Teva GmbH, TEVA BRANDED PHARM, TEVA
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
AUSTEDONDA208082TEVA BRANDED PHARMPrescription
AUSTEDO XRNDA216354TEVAPrescription
DEUTETRABENAZINEANDA215971AUROBINDO PHARMA LTDDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
AustedoTeva GmbHAuthorised08/01/2026Tardive Dyskinesia

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