Treats chronic obstructive pulmonary disease (COPD). NDA 210598, held by Mylan Ireland Ltd. Revefenacin.
As of Nov 14, 2026, NDA 210598 (Yupelri), held by Mylan Ireland Ltd, was first approved by FDA on Nov 9, 2018, with 3 approved supplements and 0 published complete response letters.
YUPELRI is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 9, 2018 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Yupelri175MCG/3ML · solution;inhalation | Revefenacin | RxReference drug |
| May 25, 2022 | Supplement 3Labeling · Standard review | Approved | |
| Nov 4, 2021 | Supplement 2Labeling · Standard review | Approved | |
| May 21, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Nov 9, 2018 | Original applicationNew molecular entity · 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
