Atrovent

NDA 19085, held by Boehringer Ingelheim. Ipratropium Bromide.

As of Nov 13, 2026, NDA 19085 (Atrovent), held by Boehringer Ingelheim, was first approved by FDA on Dec 29, 1986, with 21 approved supplements and 0 published complete response letters.

First approved: Dec 29, 1986
Review: Priority
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Dec 29, 1986	Original applicationNew molecular entity · Priority review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Atrovent0.018MG/INH · aerosol, metered;inhalation	Ipratropium Bromide	Discontinued

All 22 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 13, 2009	Supplement 16Labeling · Standard review	Approved	None posted
Mar 13, 2009	Supplement 21Labeling · Standard review	Approved	None posted
Aug 27, 2001	Supplement 20Manufacturing · Priority review	Approved	None posted
Sep 22, 2000	Supplement 19Manufacturing · Priority review	Approved	None posted
Aug 18, 1999	Supplement 18Manufacturing · Priority review	Approved	None posted
Nov 3, 1998	Supplement 17Manufacturing · Priority review	Approved	None posted
Nov 26, 1997	Supplement 15Manufacturing · Priority review	Approved	None posted
Jan 15, 1997	Supplement 9Manufacturing · Priority review	Approved	None posted
Dec 3, 1996	Supplement 14Labeling · Standard review	Approved	None posted
Jun 10, 1996	Supplement 8Manufacturing · Priority review	Approved	None posted
Apr 10, 1996	Supplement 3Manufacturing · Priority review	Approved	None posted
Jan 29, 1996	Supplement 13Labeling · Standard review	Approved	None posted
Jan 4, 1995	Supplement 6Manufacturing · Priority review	Approved	None posted
Jun 13, 1994	Supplement 11Labeling · Standard review	Approved	None posted
May 19, 1994	Supplement 10Manufacturing · Priority review	Approved	None posted
Feb 25, 1994	Supplement 7Labeling · Standard review	Approved	None posted
Jan 31, 1994	Supplement 12Manufacturing · Priority review	Approved	None posted
Mar 25, 1992	Supplement 5Manufacturing · Priority review	Approved	None posted
Mar 16, 1989	Supplement 4Labeling	Approved	None posted
Apr 27, 1988	Supplement 1Manufacturing · Priority review	Approved	None posted
Apr 21, 1988	Supplement 2Manufacturing · Priority review	Approved	None posted
Dec 29, 1986	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 19085
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