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ACTIVE SUBSTANCE / INN

METHOTREXATE

Brand name(s): Jylamvo, REDITREX, OTREXUP PFS, RASUVO, METHOTREXATE, OTREXUP, Nordimet, JYLAMVO
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA214121
NDA210737
ACTIVE SUBSTANCE
Methotrexate
REGULATORS
FDA · EMA
SPONSORS / MAH
MEDEXUS, ASSERTIO SPECLTY, ACCORD HLTHCARE
TOTAL APPLICATIONS
9
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
OTREXUPNDA204824ASSERTIO SPECLTYDiscontinued
OTREXUP PFSNDA204824ASSERTIO SPECLTYDiscontinued
REDITREXNDA210737NORDIC GRPDiscontinued
METHOTREXATENDA214121ACCORD HLTHCAREDiscontinued
RASUVONDA205776MEDEXUSDiscontinued
RASUVONDA205776MEDEXUSPrescription
JYLAMVONDA212479SHORLAPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
NordimetNordic Group B.V.Authorised18/08/2016Arthritis, Psoriatic;Psoriasis;Arthritis, Juvenile Rheumatoid;Arthritis, Rheumat…
JylamvoOresund Pharma ApSAuthorised29/03/2017Arthritis, Psoriatic;Precursor Cell Lymphoblastic Leukemia-Lymphoma;Psoriasis;Ar…

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