ANDA 75552, held by Aurobindo Pharma USA. Ipratropium Bromide.
As of Nov 15, 2026, ANDA 75552 (Ipratropium Bromide), held by Aurobindo Pharma USA, was first approved by FDA on Mar 31, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 31, 2003 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ipratropium Bromide0.021MG/SPRAY ยท spray, metered;nasal | 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
