Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 210568, held by Alkem Labs Ltd. Cefpodoxime Proxetil.
As of Nov 15, 2026, ANDA 210568 (Cefpodoxime Proxetil), held by Alkem Labs Ltd, was first approved by FDA on May 18, 2022, with 0 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, Haemophilusinfluenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase-producing strains).
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 18, 2022 | Original application | Approved | None posted |
| Cefpodoxime ProxetilEQ 100MG BASE · tablet;oral | Cefpodoxime Proxetil | Rx |
| Cefpodoxime ProxetilEQ 200MG BASE · tablet;oral | Cefpodoxime Proxetil | Rx |
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
