Combivent

NDA 20291, held by Boehringer Ingelheim. Albuterol Sulfate; Ipratropium Bromide.

As of Nov 14, 2026, NDA 20291 (Combivent), held by Boehringer Ingelheim, was first approved by FDA on Oct 24, 1996, with 16 approved supplements and 0 published complete response letters.

First approved: Oct 24, 1996
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Oct 24, 1996	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
CombiventEQ 0.09MG BASE/INH;0.018MG/INH · aerosol, metered;inhalation	Albuterol Sulfate; Ipratropium Bromide	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Sep 17, 2012	Supplement 30Labeling	Approved	Letter
Aug 20, 2012	Supplement 31Labeling	Approved	Letter Label
Apr 1, 2011	Supplement 29Labeling	Approved	Letter Label
Jun 2, 2009	Supplement 27Labeling · Standard review	Approved	Letter Label
May 7, 2009	Supplement 26Labeling · Standard review	Approved	Letter Label
Nov 10, 2008	Supplement 23Labeling · Standard review	Approved	Letter Label
Jun 1, 2006	Supplement 20Labeling · Standard review	Approved	Letter Label
Jul 23, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 16, 1999	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 18, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 23, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 22, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 19, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 26, 1997	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 14, 1997	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 8, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 24, 1996	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 20291
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