Ipratropium Bromide

ANDA 75507, held by Zennova. Ipratropium Bromide.

As of Nov 15, 2026, ANDA 75507 (Ipratropium Bromide), held by Zennova, was first approved by FDA on Jan 19, 2001, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 19, 2001
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 19, 2001	Original application	Approved	Letter

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Nov 26, 2001	Supplement 1Manufacturing	Approved	None posted
Jan 19, 2001	Original application	Approved	Letter

Identifiers

Application: ANDA 75507
Drugs@FDA: Overview at FDA
Company: Zennova

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