Treats airflow obstruction. NDA 203108, held by Boehringer Ingelheim. Olodaterol Hydrochloride.
As of Nov 13, 2026, NDA 203108 (Striverdi Respimat), held by Boehringer Ingelheim, was first approved by FDA on Jul 31, 2014, with 4 approved supplements and 0 published complete response letters.
STRIVERDI RESPIMAT Inhalation Spray is a long-acting beta 2 -adrenergic agonist (LABA) indicated for: The long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Important limitations: STRIVERDI RESPIMAT is NOT indicated to treat acute deterioration of COPD. STRIVERDI RESPIMAT is NOT indicated to treat asthma. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 31, 2014 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Striverdi RespimatEQ 0.0025MG BASE/INH · spray, metered;inhalation | Olodaterol Hydrochloride | RxReference drug |
| Dec 27, 2024 | Supplement 23Labeling · Standard review | Approved | |
| May 29, 2019 | Supplement 8Labeling · Standard review | Approved | |
| Apr 2, 2018 | Supplement 6Labeling · Standard review | Approved | |
| Jun 9, 2016 | Supplement 3Labeling · Standard review | Approved | |
| Jul 31, 2014 | 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
