ANDA 75835, held by Bausch. Ipratropium Bromide.
As of Nov 15, 2026, ANDA 75835 (Ipratropium Bromide), held by Bausch, was first approved by FDA on Oct 15, 2001, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ipratropium Bromide0.02% ยท solution;inhalation | Ipratropium Bromide | Discontinued |
| Nov 18, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Oct 2, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Oct 15, 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
