ACTIVE SUBSTANCE / INN

FLUTICASONE FUROATE

Brand name(s): FLONASE SENSIMIST ALLERGY RELIEF, ARNUITY ELLIPTA, BREO ELLIPTA, Avamys, Alisade, TRELEGY ELLIPTA
FDA LISTED
EMA LISTED
PRESCRIPTION
OVER-THE-COUNTER
LAPSED
NDA022051
NDA205625
ACTIVE SUBSTANCE
Fluticasone Furoate
REGULATORS
FDA · EMA
SPONSORS / MAH
GLAXO GRP LTD, GLAXOSMITHKLINE, Glaxo Group Ltd.
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
FLONASE SENSIMIST ALLERGY RELIEFNDA022051HALEON US HOLDINGSOver-the-counter
ARNUITY ELLIPTANDA205625GLAXOSMITHKLINEPrescription
BREO ELLIPTANDA204275GLAXO GRP LTDPrescription
TRELEGY ELLIPTANDA209482GLAXOSMITHKLINEPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
AvamysGlaxoSmithKline Trading Services LimitedAuthorised11/01/2008Rhinitis, Allergic, Seasonal;Rhinitis, Allergic, Perennial
AlisadeGlaxo Group Ltd.Lapsed06/10/2008Rhinitis, Allergic, Perennial;Rhinitis, Allergic, Seasonal

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