Treats bronchospasm associated with chronic obstructive pulmonary disease, including…. ANDA 75693, held by Ritedose Corp. Ipratropium Bromide.
As of Nov 15, 2026, ANDA 75693 (Ipratropium Bromide), held by Ritedose Corp, was first approved by FDA on Jan 26, 2001, with 6 approved supplements 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 |
|---|---|---|---|
| Jan 26, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ipratropium Bromide0.02% · solution;inhalation | Ipratropium Bromide | Rx |
| May 20, 2013 | Supplement 21Labeling · Standard review | Approved | None posted |
| Oct 21, 2011 | Supplement 15Labeling | Approved | None posted |
| Dec 17, 2002 | Supplement 4Manufacturing | Approved | None posted |
| May 7, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Apr 24, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Oct 11, 2001 | Supplement 1Labeling | Approved | None posted |
| Jan 26, 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
