Cefixime tablets are cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients weighing more than 45 kg or older than 12 years with the following infections: Uncomplicated Urinary Tract Infections Pharyngitis and Tonsillitis Acute Exacerbations of Chronic Bronchitis Uncomplicated Gonorrhea (cervical/urethral) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefixime tablets and other antibacterial drugs, cefixime tablets should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. 1.1 Uncomplicated Urinary Tract Infections
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 17, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cefixime400MG · tablet;oral | Cefixime | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
