NDAORALTABLET, CHEWABLE, TABLET, CAPSULE
Approved
Aug 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
HELIDAC (bismuth subsalicylate; metronidazole; tetracycline hydrochloride) by R-Pharm US. Approved for travelers' diarrhea diarrhea upset stomach due to overindulgence in food, drink, including: heartburn indigestion nausea gas belching fullness. First approved in 1996.
Drug data last refreshed 2h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HELIDAC is a fixed-dose combination oral tablet containing bismuth subsalicylate, metronidazole, and tetracycline hydrochloride. It is indicated for travelers' diarrhea and gastrointestinal upset from dietary indiscretion, addressing symptoms including heartburn, indigestion, nausea, gas, and bloating. The formulation leverages antimicrobial and anti-inflammatory mechanisms to manage acute GI disturbances.
LOE Approaching
Approaching loss of exclusivity with limited team growth opportunity; focus shifting toward generic transition and cost-management strategies.
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.