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ACTIVE SUBSTANCE / INN

ARSENIC TRIOXIDE

Brand name(s): Arsenic trioxide Mylan, TRISENOX, Trisenox, Arsenic trioxide medac, Arsenic trioxide Accord, ARSENIC TRIOXIDE
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
WITHDRAWN
ANDA078729
ANDA209873
ACTIVE SUBSTANCE
Arsenic Trioxide
REGULATORS
FDA · EMA
SPONSORS / MAH
TEVA PHARMS, Mylan Ireland Limited, CEPHALON
TOTAL APPLICATIONS
9
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ARSENIC TRIOXIDEANDA209873PENN LIFEPrescription
TRISENOXNDA021248CEPHALONPrescription
TRISENOXNDA021248CEPHALONDiscontinued
ARSENIC TRIOXIDEANDA209315INGENUS PHARMS LLCDiscontinued
ARSENIC TRIOXIDEANDA078729TEVA PHARMSNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Arsenic trioxide AccordAccord Healthcare S.L.U.Authorised14/11/2019Leukemia, Promyelocytic, Acute
TrisenoxTeva B.V.Authorised05/03/2002Leukemia, Promyelocytic, Acute
Arsenic trioxide MylanMylan Ireland LimitedWithdrawn01/04/2020Leukemia, Promyelocytic, Acute
Arsenic trioxide medacmedac Gesellschaft für klinische Spezialpräparate mbHAuthorised17/09/2020Leukemia, Promyelocytic, Acute

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