ANDA 204835, held by Aurobindo Pharma Ltd. Cefixime.
As of Nov 13, 2026, ANDA 204835 (Cefixime), held by Aurobindo Pharma Ltd, was first approved by FDA on Apr 14, 2015, with 1 approved supplement and 0 published complete response letters.
Cefixime for oral suspension 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 Otitis Media 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 for oral suspension and other antibacterial drugs, cefixime for oral suspension 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 |
|---|---|---|---|
| Apr 14, 2015 | Original application | Approved |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 27, 2016 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 14, 2015 | Original application | Approved |
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
