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ACTIVE SUBSTANCE / INN

AMBRISENTAN

Brand name(s): Ambrisentan Viatris (previously Ambrisentan Mylan), LETAIRIS, AMBRISENTAN, Ambrisentan Zentiva, Volibris
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
DISCONTINUED
Hypertension, Pulmonary
NDA022081
ACTIVE SUBSTANCE
Ambrisentan
REGULATORS
FDA · EMA
SPONSORS / MAH
MYLAN, PH HEALTH, Viatris Limited
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
AMBRISENTANANDA208441MYLANPrescription
AMBRISENTANANDA209509PH HEALTHDiscontinued
LETAIRISNDA022081GILEADPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Ambrisentan Viatris (previously Ambrisentan Mylan)Viatris LimitedAuthorised20/06/2019Hypertension, Pulmonary
VolibrisGlaxoSmithKline Trading Services LimitedAuthorised21/04/2008Hypertension, Pulmonary
Ambrisentan ZentivaZentiva, k.s.Application withdrawnHypertension, Pulmonary

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