Ipratropium Bromide

ANDA 75553, held by Aurobindo Pharma USA. Ipratropium Bromide.

As of Nov 15, 2026, ANDA 75553 (Ipratropium Bromide), held by Aurobindo Pharma USA, was first approved by FDA on Mar 31, 2003, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 31, 2003
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
Mar 31, 2003	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ipratropium Bromide0.042MG/SPRAY · spray, metered;nasal	Ipratropium Bromide	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Nov 6, 2007	Supplement 3Labeling	Approved	None posted
Mar 31, 2003	Original application	Approved	Review

Identifiers

Application: ANDA 75553
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma USA

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