ONDANSETRON HYDROCHLORIDE

Post-LOE

ondansetron hydrochloride

PharmaIN

ANDAINJECTIONINJECTABLE

Approved

Dec 2006

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

ONDANSETRON HYDROCHLORIDE (ondansetron hydrochloride) by PharmaIN is 5-ht 3 receptor antagonist. Approved for nausea, vomiting associated with initial, repeat courses of emetogenic cancer chemotherapy and 2 more indications. First approved in 2006.

Drug data last refreshed 1w ago

Mechanism of Action

5-HT 3 receptor antagonist. While ondansetron's mechanism of action has not been fully characterized, it is not a dopamine-receptor antagonist.

Indications (5)

nausea vomiting associated with initial repeat courses of emetogenic cancer chemotherapy

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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.

Clinical Trials (2)

NCT01511705Phase 1Completed

Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition

Started Oct 2006

26 enrolled

Healthy

NCT01511718Phase 1Completed

Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fed Condition

Started Oct 2006

26 enrolled

Healthy