ANDA 208959, held by Actavis Labs Fl Inc. Rifaximin.
As of Nov 15, 2026, ANDA 208959 (Rifaximin), held by Actavis Labs Fl Inc, was first approved by FDA on Mar 19, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 19, 2026 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rifaximin550MG ยท tablet;oral | Rifaximin | Rx |
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
