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ACTIVE SUBSTANCE / INN

TREPROSTINIL

Brand name(s): REMODULIN, TYVASO, TREPROSTINIL, Treprostinil SciPharm Sàrl, TYVASO DPI, Trepulmix
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
APPLICATION WITHDRAWN
ANDA209382
NDA021272
ACTIVE SUBSTANCE
Treprostinil
REGULATORS
FDA · EMA
SPONSORS / MAH
DR REDDYS, ACTAVIS LABS, PH HEALTH
TOTAL APPLICATIONS
9
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TREPROSTINILANDA210214DR REDDYSPrescription
REMODULINNDA021272UNITED THERAPDiscontinued
REMODULINNDA021272UNITED THERAPPrescription
TYVASO DPINDA214324UNITED THERAPPrescription
TREPROSTINILANDA208906ACTAVIS LABSNone (Tentative Approval)
TYVASONDA022387UNITED THERAPPrescription
TREPROSTINILANDA209382PH HEALTHDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
TrepulmixSciPharm SàrlAuthorised03/04/2020Hypertension, Pulmonary
Treprostinil SciPharm SàrlSciPharm SàrlApplication withdrawnHypertension, Pulmonary

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