Ipratropium Bromide

ANDA 75111, held by Actavis Mid Atlantic. Ipratropium Bromide.

As of Nov 15, 2026, ANDA 75111 (Ipratropium Bromide), held by Actavis Mid Atlantic, was first approved by FDA on Apr 22, 1999, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 22, 1999
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Apr 22, 1999	Original application	Approved	Letter Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ipratropium Bromide0.02% · solution;inhalation	Ipratropium Bromide	Discontinued

All 10 submissions, including labeling and manufacturing supplements


May 21, 2002	Supplement 9Manufacturing	Approved	None posted
Jan 25, 2002	Supplement 8Manufacturing	Approved	None posted
Apr 3, 2001	Supplement 7Manufacturing	Approved	None posted
Oct 23, 2000	Supplement 3Manufacturing	Approved	None posted
Oct 23, 2000	Supplement 2Manufacturing	Approved	None posted
Oct 23, 2000	Supplement 1Manufacturing	Approved	None posted
Aug 17, 2000	Supplement 6Labeling	Approved	None posted
Aug 17, 2000	Supplement 5Manufacturing	Approved	None posted
Aug 17, 2000	Supplement 4Manufacturing	Approved	None posted
Apr 22, 1999	Original application	Approved	Letter Label Review

Identifiers

Application: ANDA 75111
Drugs@FDA: Overview at FDA
Company: Actavis Mid Atlantic LLC

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