NDAINJECTIONINJECTABLEPriority Review
Approved
Nov 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
FLAGYL I.V. (metronidazole hydrochloride) by Pfizer is (metronidazole and tetracycline hydrochloride) and bismuth subcitrate potassium [see microbiology ()] . Approved for duodenal ulcer disease (active, history of within the past 5 years) to eradicate h. First approved in 1980.
Drug data last refreshed 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLAGYL I.V. is a metronidazole hydrochloride injection used to treat active duodenal ulcer disease and eradicate H. pylori infection. It is a small-molecule nitroimidazole antibiotic that works by disrupting bacterial DNA synthesis. This is an older, established therapeutic indicated for serious anaerobic and protozoal infections requiring parenteral administration.
LOE Approaching
Product is in late-stage lifecycle with approaching loss of exclusivity, likely supporting a smaller, maintenance-focused commercial team.
Mechanism of Action
(metronidazole and tetracycline hydrochloride) and bismuth subcitrate potassium [see Microbiology ()] .
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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.