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As of Nov 14, 2026, NDA 203195 (Suprax), held by Lupin Ltd, was first approved by FDA on Jun 1, 2012, with 8 approved supplements and 0 published complete response letters.
First approved: Jun 1, 2012
Review: Standard
Supplements approved: 8
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
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 Otitis Media 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 and other antibacterial drugs, cefixime for oral suspension and cefixime capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. 1.
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
