ANDA 207366, held by Chartwell Rx. Ribavirin.
As of Nov 14, 2026, ANDA 207366 (Ribavirin), held by Chartwell Rx, was first approved by FDA on Oct 6, 2016, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 6, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ribavirin6GM/VIAL ยท for solution;inhalation | Ribavirin | 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
