Treats bronchospasm associated with chronic obstructive pulmonary disease, including…. ANDA 75562, held by Nephron. Ipratropium Bromide.
As of Nov 15, 2026, ANDA 75562 (Ipratropium Bromide), held by Nephron, was first approved by FDA on Sep 27, 2001, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Ipratropium bromide inhalation solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ipratropium Bromide0.02% · solution;inhalation | Ipratropium Bromide | Rx |
| Mar 29, 2007 | Supplement 1Labeling | Approved | None posted |
| Sep 27, 2001 | Original application | Approved |
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
