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ACTIVE SUBSTANCE / INN

FEBUXOSTAT

Brand name(s): ULORIC, Febuxostat Viatris (previously Febuxostat Mylan), Adenuric, FEBUXOSTAT, Febuxostat Krka
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
Gout
NDA021856
ACTIVE SUBSTANCE
Febuxostat
REGULATORS
FDA · EMA
SPONSORS / MAH
Menarini International Operations Luxembourg S.A. (MIOL), TAKEDA PHARMS USA, PHARMOBEDIENT
TOTAL APPLICATIONS
7
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
FEBUXOSTATANDA205385PHARMOBEDIENTDiscontinued
FEBUXOSTATANDA210461MSNPrescription
ULORICNDA021856TAKEDA PHARMS USAPrescription
FEBUXOSTATANDA211339BEIJING SL PHARMA CO LTDNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
AdenuricMenarini International Operations Luxembourg S.A. (MIOL)Authorised21/04/2008Gout
Febuxostat Viatris (previously Febuxostat Mylan)Viatris LimitedAuthorised15/06/2017Hyperuricemia;Arthritis, Gouty;Gout
Febuxostat KrkaKrka, d.d., Novo mestoAuthorised28/03/2019Hyperuricemia;Gout

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