ANDA 65129, held by Lupin Pharms. Cefixime.
As of Nov 13, 2026, ANDA 65129 (Suprax), held by Lupin Pharms, was first approved by FDA on Feb 23, 2004, with 6 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 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 2004 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Suprax100MG/5ML · for suspension;oral | Cefixime | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 4, 2018 | Supplement 32Manufacturing | Approved | None posted |
| Jun 13, 2016 | Supplement 27Labeling · Standard review | Approved | None posted |
| Mar 29, 2013 | Supplement 25Labeling · Standard review | Approved | None posted |
| Feb 25, 2009 | Supplement 9Labeling | Approved | None posted |
| Oct 6, 2005 | Supplement 7Labeling | Approved | None posted |
| Dec 9, 2004 | Supplement 3Labeling | Approved | None posted |
| Feb 23, 2004 | Original application | Approved | None posted |
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
