ANDA 217607, held by Aurobindo Pharma Ltd. Cefixime.
As of Nov 13, 2026, ANDA 217607 (Cefixime), held by Aurobindo Pharma Ltd, was first approved by FDA on Mar 23, 2026, with 0 approved supplements and 0 published complete response letters.
Cefixime is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections: Uncomplicated Urinary Tract Infections Pharyngitis and Tonsillitis Acute Exacerbations of Chronic Bronchitis Uncomplicated Gonorrhea (cervical/urethral) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefixime capsules and other antibacterial drugs, cefixime capsules 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 |
|---|---|---|---|
| Mar 23, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cefixime400MG · capsule;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
