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FDA NDA · NDA209482

TRELEGY ELLIPTA

fluticasone furoate, umeclidinium bromide and vilanterol trifenatate

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA209482
TYPE
NDA
ORIGINAL APPROVAL
2017-09-18
LATEST ACTION
2023-06-02
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

TRELEGY ELLIPTA · ReferencePrescription
FLUTICASONE FUROATE 0.1MG/INH, UMECLIDINIUM BROMIDE EQ 0.0625MG BASE/INH, VILANTEROL TRIFENATATE EQ 0.025MG BASE/INH · POWDER · INHALATION
TRELEGY ELLIPTA · ReferencePrescription
FLUTICASONE FUROATE 0.2MG/INH, UMECLIDINIUM BROMIDE EQ 0.0625MG BASE/INH, VILANTEROL TRIFENATATE EQ 0.025MG BASE/INH · POWDER · INHALATION

Approval history

2023-06-02Labeling · Supplement 18 · standard — Letter ↗AP
2022-12-02Labeling · Supplement 16 · standard — Label ↗AP
2022-05-11Labeling · Supplement 13 · standard — Letter ↗AP
2020-09-09Efficacy · Supplement 10 · standard — Letter ↗AP
2020-09-09Labeling · Supplement 11 · standard — Letter ↗AP
2019-05-15Labeling · Supplement 5 · standard — Letter ↗AP
2019-01-07Labeling · Supplement 2 · standard — Label ↗AP
2019-01-07Labeling · Supplement 3 · standard — Label ↗AP
2018-04-24Efficacy · Supplement 1 · standard — Label ↗AP
2017-09-18Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
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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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