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ACTIVE SUBSTANCE / INN

MACITENTAN

Brand name(s): MACITENTAN, OPSUMIT, Opsumit, Macitentan AccordPharma, Macitentan Accord, OPSYNVI
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA211136
NDA204410
ACTIVE SUBSTANCE
Macitentan
REGULATORS
FDA · EMA
SPONSORS / MAH
Janssen-Cilag International N.V.  , RHODES PHARMS, MSN
TOTAL APPLICATIONS
8
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
OPSUMITNDA204410ACTELIONPrescription
MACITENTANANDA211136MSNPrescription
MACITENTANANDA211195APOTEXDiscontinued
OPSYNVINDA218490ACTELIONPrescription
MACITENTANANDA214112RHODES PHARMSNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Macitentan AccordPharmaAccord HealthcareAuthorised24/09/2025Hypertension, Pulmonary
Macitentan AccordAccord HealthcareAuthorised24/09/2025Hypertension, Pulmonary
OpsumitJanssen-Cilag International N.V.  Authorised20/12/2013Hypertension, Pulmonary

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