Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 65409, held by Aurobindo Pharma Ltd. Cefpodoxime Proxetil.
As of Nov 15, 2026, ANDA 65409 (Cefpodoxime Proxetil), held by Aurobindo Pharma Ltd, was first approved by FDA on Jun 8, 2007, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Acute otitis media caused by Streptococcus pneumoniae (excluding penicillin-resistant strains), Streptococcus pyogenes, Haemophilus influenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase producing strains).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 8, 2007 | Original application | Approved | None posted |
| Cefpodoxime ProxetilEQ 50MG BASE/5ML · for suspension;oral | Cefpodoxime Proxetil | Rx |
| Cefpodoxime ProxetilEQ 100MG BASE/5ML · for suspension;oral | Cefpodoxime Proxetil | Rx |
| Sep 21, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 29, 2007 | Supplement 1Labeling | Approved | None posted |
| Jun 8, 2007 | Original application | Approved | None posted |
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
