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Data updated: Mar 10, 2026

CEFPODOXIME PROXETIL

CEFPODOXIME PROXETIL
Infectious Disease Approved 2002-05-31
8
Indications
--
Phase 3 Trials
23
Years on Market

Details

Status
Prescription
First Approved
2002-05-31
Routes
ORAL
Dosage Forms
TABLET, FOR SUSPENSION

CEFPODOXIME PROXETIL Approval History

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What CEFPODOXIME PROXETIL Treats

5 indications

CEFPODOXIME PROXETIL is approved for 5 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Acute Otitis Media
  • Pharyngitis
  • Tonsillitis
  • Community-Acquired Pneumonia
  • Acute Bacterial Exacerbation of Chronic Bronchitis
Source: FDA Label

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CEFPODOXIME PROXETIL FDA Label Details

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Indications & Usage

FDA Label (PDF)

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 (includ...

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.