← FDA DRUG APPROVALS

FDA NDA · NDA203975

UMECLIDINIUM AND VILANTEROL ELLIPTA

umeclidinium bromide and vilanterol trifenatate

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA203975
TYPE
NDA
ORIGINAL APPROVAL
2013-12-18
LATEST ACTION
2023-06-02
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ANORO ELLIPTA · ReferencePrescription
UMECLIDINIUM BROMIDE EQ 0.0625MG BASE/INH, VILANTEROL TRIFENATATE EQ 0.025MG BASE/INH · POWDER · INHALATION

Approval history

2023-06-02Labeling · Supplement 15 · standard — Letter ↗AP
2022-10-20Labeling · Supplement 13 · standard — Letter ↗AP
2019-06-06Efficacy · Supplement 10 · standard — Label ↗AP
2019-05-29Labeling · Supplement 9 · standard — Label ↗AP
2017-10-17Labeling · Supplement 7 · standard — Label ↗AP
2017-03-22Labeling · Supplement 5 · standard — Label ↗AP
2016-02-24Labeling · Supplement 3 · standard — Label ↗AP
2015-08-27Manufacturing (CMC) · Supplement 2 · standardAP
2015-08-07Manufacturing (CMC) · Supplement 1 · standardAP
2013-12-18Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →