Treats chronic obstructive pulmonary disease (COPD). NDA 205382, held by Glaxo Grp England. Umeclidinium Bromide.
As of Nov 15, 2026, NDA 205382 (Incruse Ellipta), held by Glaxo Grp England, was first approved by FDA on Apr 30, 2014, with 5 approved supplements and 0 published complete response letters.
Umeclidinium ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
| Jun 6, 2019 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Feb 24, 2016 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Apr 30, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Incruse ElliptaEQ 0.0625MG BASE/INH · powder;inhalation | Umeclidinium Bromide | RxReference drug |
| Dec 13, 2023 | Supplement 13Labeling · Standard review | Approved | |
| Jun 6, 2019 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Oct 20, 2017 | Supplement 8Labeling · Standard review | Approved | |
| Jun 13, 2017 | Supplement 6Labeling · Standard review | Approved | |
| Feb 24, 2016 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Apr 30, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
