Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 65370, held by Aurobindo Pharma. Cefpodoxime Proxetil.
As of Nov 15, 2026, ANDA 65370 (Cefpodoxime Proxetil), held by Aurobindo Pharma, was first approved by FDA on Jun 11, 2007, with 3 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 11, 2007 | Original application | Approved | None posted |
| Cefpodoxime ProxetilEQ 100MG BASE · tablet;oral | Cefpodoxime Proxetil | Rx |
| Cefpodoxime ProxetilEQ 200MG BASE · tablet;oral | Cefpodoxime Proxetil | Rx |
| Sep 21, 2015 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jun 16, 2008 | Supplement 4Labeling | Approved | None posted |
| Nov 29, 2007 | Supplement 1Labeling | Approved | None posted |
| Jun 11, 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
