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ACTIVE SUBSTANCE / INN

TOFACITINIB

Brand name(s): Xeljanz, TOFACITINIB
FDA LISTED
EMA LISTED
REFUSED
AUTHORISED
NONE (TENTATIVE APPROVAL)
ANDA209633
Arthritis, Rheumatoid
ACTIVE SUBSTANCE
Tofacitinib
REGULATORS
FDA · EMA
SPONSORS / MAH
Pfizer Limited, BRECKENRIDGE PHARMS, Pfizer Europe MA EEIG
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TOFACITINIBANDA209633BRECKENRIDGE PHARMSNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
XeljanzPfizer Europe MA EEIGAuthorised22/03/2017Arthritis, Rheumatoid
XeljanzPfizer LimitedRefusedArthritis, Rheumatoid

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