NDA 202049, held by Pharmaxis Europe. Mannitol.
As of Nov 14, 2026, NDA 202049 (Bronchitol), held by Pharmaxis Europe, was first approved by FDA on Oct 30, 2020, with 0 approved supplements and 2 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 30, 2020 | Original applicationNew indication · Standard review | Approved |
| Jun 19, 2019 | Mannitol | Approved |
| Mar 18, 2013 | Bronchitol (mannitol)Clinical, Product Quality, Labeling | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bronchitol40MG · powder;inhalation | Mannitol | RxReference drug |
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
