ANDA 75313, held by Teva Pharms USA. Ipratropium Bromide.
As of Nov 15, 2026, ANDA 75313 (Ipratropium Bromide), held by Teva Pharms USA, was first approved by FDA on Feb 7, 2000, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 7, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ipratropium Bromide0.02% ยท solution;inhalation | Ipratropium Bromide | Discontinued |
| Aug 24, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Aug 24, 2001 | Supplement 2Labeling | Approved | None posted |
| Feb 7, 2000 | 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
