NDAORALFOR SUSPENSION
Approved
May 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
AUGMENTIN '200' (amoxicillin; clavulanate potassium) by Pfizer. Approved for infections due to susceptible strains of designated microorganisms, the treatment of infections due to susceptible (only β-lactamase–negative) isolates of streptococcus species, the treatment of infections due to susceptible (only β-lactamase–negative) isolates of escherichia coli and 3 more indications. First approved in 1996.
Drug data last refreshed 9h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUGMENTIN '200' is an oral suspension combining amoxicillin (a β-lactam antibiotic) with clavulanate potassium (a β-lactamase inhibitor). It treats bacterial infections caused by susceptible gram-positive and gram-negative organisms including Streptococcus, E. coli, Proteus mirabilis, and Enterococcus faecalis. The clavulanate component protects amoxicillin from enzymatic degradation, restoring efficacy against β-lactamase-producing strains.
LOE Approaching
Product is in late-stage lifecycle (LOE approaching) with moderate competitive pressure (30/100), indicating team focus is shifting toward lifecycle management, transition planning, and positioning against newer agents.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.