ANDA 75441, held by Apotex Inc. Ipratropium Bromide.
As of Nov 15, 2026, ANDA 75441 (Ipratropium Bromide), held by Apotex Inc, was first approved by FDA on Mar 28, 2001, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 28, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ipratropium Bromide0.02% ยท solution;inhalation | Ipratropium Bromide | Discontinued |
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
