← FDA DRUG APPROVALS

FDA NDA · NDA204275

BREO ELLIPTA

fluticasone furoate and vilanterol trifenatate

Sponsor: GLAXO GRP LTD

APPLICATION
NDA204275
TYPE
NDA
ORIGINAL APPROVAL
2013-05-10
LATEST ACTION
2023-05-12
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

BREO ELLIPTA · ReferencePrescription
FLUTICASONE FUROATE 0.2MG/INH, VILANTEROL TRIFENATATE EQ 0.025MG BASE/INH · POWDER · INHALATION
BREO ELLIPTA · ReferencePrescription
FLUTICASONE FUROATE 0.05MG/INH, VILANTEROL TRIFENATATE EQ 0.025MG BASE/INH · POWDER · INHALATION
BREO ELLIPTA · ReferencePrescription
FLUTICASONE FUROATE 0.1MG/INH, VILANTEROL TRIFENATATE EQ 0.025MG BASE/INH · POWDER · INHALATION

Approval history

2023-05-12Efficacy · Supplement 22 · priority — Letter ↗AP
2019-01-07Labeling · Supplement 17 · standard — Label ↗AP
2017-12-20Labeling · Supplement 15 · standard — Label ↗AP
2017-05-15Efficacy · Supplement 12 · standard — Label ↗AP
2016-10-31Labeling · Supplement 11 · standard — Letter ↗AP
2016-02-16Labeling · Supplement 9 · standard — Label ↗AP
2015-10-21Manufacturing (CMC) · Supplement 8 · standardAP
2015-09-15Labeling · Supplement 4 · standard — Label ↗AP
2015-08-11Manufacturing (CMC) · Supplement 5 · standardAP
2015-04-30Efficacy · Supplement 1 · standard — Label ↗AP
2015-03-02Labeling · Supplement 2 · standard — Letter ↗AP
2013-05-10Type 1 - New Molecular Entity · 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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