Atrovent Hfa

Treats bronchospasm associated with chronic obstructive pulmonary disease (COPD)…. NDA 21527, held by Boehringer Ingelheim. Ipratropium Bromide.

As of Nov 14, 2026, NDA 21527 (Atrovent Hfa), held by Boehringer Ingelheim, was first approved by FDA on Nov 17, 2004, with 12 approved supplements and 0 published complete response letters.

First approved: Nov 17, 2004
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ATROVENT HFA Inhalation Aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ATROVENT HFA is an anticholinergic indicated for the 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 13 submissions below

Date	Submission	Status	Documents
Nov 17, 2004	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Atrovent Hfa0.021MG/INH · aerosol, metered;inhalation	Ipratropium Bromide	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Dec 30, 2024	Supplement 42Labeling · Standard review	Approved	Letter Label
Jan 10, 2020	Supplement 33Labeling · Standard review	Approved	Letter Label
Aug 11, 2016	Supplement 27Labeling · Standard review	Approved	Letter
Apr 29, 2016	Supplement 26Manufacturing · Standard review	Approved	None posted
Apr 29, 2015	Supplement 22Manufacturing · Standard review	Approved	None posted
May 9, 2014	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 30, 2012	Supplement 21Labeling	Approved	Letter Label
Oct 6, 2011	Supplement 19Manufacturing	Approved	Letter Label
Dec 23, 2010	Supplement 16Labeling	Approved	Letter Label
Oct 14, 2008	Supplement 11Labeling · Standard review	Approved	Letter
Sep 5, 2006	Supplement 5Labeling · Standard review	Approved	Letter Label
Mar 23, 2006	Supplement 3Labeling · Standard review	Approved	Letter
Nov 17, 2004	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21527
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