Spiriva Respimat

Treats bronchospasm associated with chronic obstructive pulmonary disease (COPD). NDA 21936, held by Boehringer Ingelheim. Tiotropium Bromide.

As of Nov 14, 2026, NDA 21936 (Spiriva Respimat), held by Boehringer Ingelheim, was first approved by FDA on Sep 24, 2014, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 24, 2014
Review: Standard
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SPIRIVA RESPIMAT is an anticholinergic indicated for: The long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations The long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older Limitation of Use: Not indicated for relief of acute bronchospasm ( 1.1, 1.2, 5.1 ) 1.1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease SPIRIVA RESPIMAT (tiotropium bromide) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below


Feb 15, 2017	Supplement 7Efficacy (new indication or use) · Priority review	Approved	Label
Sep 24, 2014	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


Spiriva RespimatEQ 0.0025MG BASE/INH · spray, metered;inhalation	Tiotropium Bromide	RxReference drug
Spiriva RespimatEQ 0.00125MG BASE/INH · spray, metered;inhalation	Tiotropium Bromide	RxReference drug

All 6 submissions, including labeling and manufacturing supplements


Dec 27, 2024	Supplement 36Labeling · Standard review	Approved	Label Letter
Feb 14, 2019	Supplement 12Labeling · Standard review	Approved	Letter Label
Feb 15, 2017	Supplement 7Efficacy (new indication or use) · Priority review	Approved	Label
Jun 9, 2016	Supplement 5Labeling · Standard review	Approved	Label Letter
Jan 15, 2016	Supplement 3Labeling · Standard review	Approved	Label Letter
Sep 24, 2014	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 21936
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