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ACTIVE SUBSTANCE / INN

TASIMELTEON

Brand name(s): TASIMELTEON, HETLIOZ LQ, Hetlioz, HETLIOZ
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
Sleep Disorders, Circadian Rhythm
NDA205677
ACTIVE SUBSTANCE
Tasimelteon
REGULATORS
FDA · EMA
SPONSORS / MAH
Vanda Pharmaceuticals Netherlands B.V., VANDA PHARMS INC, APOTEX
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TASIMELTEONANDA211607APOTEXPrescription
HETLIOZ LQNDA214517VANDA PHARMS INCPrescription
HETLIOZNDA205677VANDA PHARMS INCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
HetliozVanda Pharmaceuticals Netherlands B.V.Authorised03/07/2015Sleep Disorders, Circadian Rhythm

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