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ACTIVE SUBSTANCE / INN

RIOCIGUAT

Brand name(s): RIOCIGUAT, Adempas, ADEMPAS
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NONE (TENTATIVE APPROVAL)
ANDA211044
ANDA211135
ACTIVE SUBSTANCE
Riociguat
REGULATORS
FDA · EMA
SPONSORS / MAH
Bayer AG, MSN, TEVA PHARMS USA INC
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
RIOCIGUATANDA211135MSNPrescription
ADEMPASNDA204819BAYER HLTHCAREPrescription
RIOCIGUATANDA211044TEVA PHARMS USA INCNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
AdempasBayer AGAuthorised27/03/2014Hypertension, Pulmonary

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