CEFPODOXIME PROXETIL
Details
- Status
- Prescription
- First Approved
- 2002-05-31
- Routes
- ORAL
- Dosage Forms
- TABLET, FOR SUSPENSION
CEFPODOXIME PROXETIL Approval History
What CEFPODOXIME PROXETIL Treats
5 indicationsCEFPODOXIME 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
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
ProIndications & 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.