ANDA 214369, held by Norwich Pharmaceuticals Inc. Rifaximin.
As of Nov 15, 2026, ANDA 214369 (Rifaximin), held by Norwich Pharmaceuticals Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 20, 2024 | Original application | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rifaximin550MG ยท tablet;oral | Rifaximin | None (tentative approval) |
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
