Atrovent

NDA 20393, held by Boehringer Ingelheim. Ipratropium Bromide.

As of Nov 13, 2026, NDA 20393 (Atrovent), held by Boehringer Ingelheim, was first approved by FDA on Oct 20, 1995, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 20, 1995
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


Apr 1, 1998	Supplement 1Efficacy (new indication or use)	Approved	Letter
Oct 20, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Atrovent0.021MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray, metered;nasal	Ipratropium Bromide	DiscontinuedReference drug

All 9 submissions, including labeling and manufacturing supplements


May 11, 2015	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 5, 2015	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 2, 2011	Supplement 11Labeling	Approved	Letter
Dec 4, 2007	Supplement 7Labeling · Standard review	Approved	Letter Label
May 23, 2003	Supplement 4Labeling · Standard review	Approved	Label Letter
Jan 27, 2000	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 18, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 1, 1998	Supplement 1Efficacy (new indication or use)	Approved	Letter
Oct 20, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20393
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