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FDA NDA · NDA205382

INCRUSE ELLIPTA

umeclidinium

Sponsor: GLAXO GRP ENGLAND

APPLICATION
NDA205382
TYPE
NDA
ORIGINAL APPROVAL
2014-04-30
LATEST ACTION
2023-12-13
ROUTE
ORAL, INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

INCRUSE ELLIPTA · ReferencePrescription
UMECLIDINIUM BROMIDE EQ 0.0625MG BASE/INH · POWDER · INHALATION

Approval history

2023-12-13Labeling · Supplement 13 · standard — Letter ↗AP
2019-06-06Efficacy · Supplement 10 · standard — Letter ↗AP
2017-10-20Labeling · Supplement 8 · standard — Letter ↗AP
2017-06-13Labeling · Supplement 6 · standard — Label ↗AP
2016-02-24Efficacy · Supplement 2 · standard — Label ↗AP
2014-04-30Type 5 - New Formulation or New Manufacturer · Original · standard — Summary 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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