Sold as Cedax. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 2 applications for Ceftibuten Dihydrate (sold as Cedax), first approved Dec 20, 1995, with 0 new uses approved and 0 published complete response letters.
| Study | Phase | Status | Posted |
|---|---|---|---|
| Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose CombinationHealthy Volunteer, Pharmacokinetics · Basilea Pharmaceutica | Phase 1 | Recruiting | Dec 13, 2024 |
| Dec 20, 1995 | CedaxNDA 50685 · New molecular entity | Burke Therap | 9 | Discontinued |
| Dec 20, 1995 | CedaxNDA 50686 · New dosage form | Burke Therap | 13 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
