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FDA NDA · NDA205625

FLUTICASONE FUROATE ELLIPTA

fluticasone furoate

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA205625
TYPE
NDA
ORIGINAL APPROVAL
2014-08-20
LATEST ACTION
2023-10-18
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ARNUITY ELLIPTA · ReferencePrescription
FLUTICASONE FUROATE 0.2MG/INH · POWDER · INHALATION
ARNUITY ELLIPTA · ReferencePrescription
FLUTICASONE FUROATE 0.05MG/INH · POWDER · INHALATION
ARNUITY ELLIPTA · ReferencePrescription
FLUTICASONE FUROATE 0.1MG/INH · POWDER · INHALATION

Approval history

2023-10-18Labeling · Supplement 11 · standard — Letter ↗AP
2023-03-01Efficacy · Supplement 9 · standard — Letter ↗AP
2019-01-07Labeling · Supplement 7 · standard — Label ↗AP
2018-05-17Efficacy · Supplement 5 · standard — Label ↗AP
2015-03-20Labeling · Supplement 1 · standard — Label ↗AP
2014-08-20Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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