Stiolto Respimat

Treats chronic obstructive pulmonary disease (COPD). NDA 206756, held by Boehringer Ingelheim. Olodaterol Hydrochloride; Tiotropium Bromide.

As of Nov 13, 2026, NDA 206756 (Stiolto Respimat), held by Boehringer Ingelheim, was first approved by FDA on May 21, 2015, with 6 approved supplements and 0 published complete response letters.

First approved: May 21, 2015
Review: Standard
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

STIOLTO RESPIMAT is a combination of tiotropium bromide, an anticholinergic and olodaterol, a long-acting beta 2 -adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Important limitations: STIOLTO RESPIMAT is NOT indicated to treat acute deterioration of COPD. STIOLTO RESPIMAT is NOT indicated to treat asthma. 1.1 Maintenance Treatment of COPD STIOLTO RESPIMAT is a combination of tiotropium bromide and olodaterol indicated for long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


Oct 5, 2018	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 18, 2016	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 21, 2015	Original applicationNew combination · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Stiolto RespimatEQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH · spray, metered;inhalation	Olodaterol Hydrochloride; Tiotropium Bromide	RxReference drug

All 7 submissions, including labeling and manufacturing supplements


Dec 30, 2024	Supplement 36Labeling · Standard review	Approved	Label Letter
May 29, 2019	Supplement 11Labeling · Standard review	Approved	Letter Label
Oct 5, 2018	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 9, 2016	Supplement 6Labeling · Standard review	Approved	Label Letter
Mar 18, 2016	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 16, 2015	Supplement 1Labeling · Standard review	Approved	Label Letter
May 21, 2015	Original applicationNew combination · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 206756
Drugs@FDA: Overview at FDA
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

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