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ACTIVE SUBSTANCE / INN

BOSENTAN

Brand name(s): BOSENTAN, Tracleer, TRACLEER
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA209324
Scleroderma, Systemic;Hypertension, Pulmonary
ACTIVE SUBSTANCE
Bosentan
REGULATORS
FDA · EMA
SPONSORS / MAH
ALEMBIC, SUN PHARM, ACTELION
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
BOSENTANANDA209324SUN PHARMPrescription
BOSENTANANDA211461ALEMBICDiscontinued
TRACLEERNDA209279ACTELIONPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
TracleerJanssen-Cilag International N.V.  Authorised14/05/2002Scleroderma, Systemic;Hypertension, Pulmonary

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