Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 65462, held by Sandoz. Cefpodoxime Proxetil.
As of Nov 15, 2026, ANDA 65462 (Cefpodoxime Proxetil), held by Sandoz, was first approved by FDA on May 28, 2008, with 1 approved supplement 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 |
|---|---|---|---|
| May 28, 2008 | Original application | Approved | None posted |
| Cefpodoxime ProxetilEQ 100MG BASE · tablet;oral | Cefpodoxime Proxetil | Rx |
| Cefpodoxime ProxetilEQ 200MG BASE · tablet;oral | Cefpodoxime Proxetil | Rx |
| Feb 5, 2014 | Supplement 5Labeling · Standard review | Approved | |
| May 28, 2008 | 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
