ONDANSETRON HYDROCHLORIDE

Post-LOE

ondansetron hydrochloride

Dr. Reddy's Laboratories

ANDAORALTABLET

Approved

Dec 2006

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

ONDANSETRON HYDROCHLORIDE (ondansetron hydrochloride) by Dr. Reddy's Laboratories is 5-ht 3 receptor antagonist. Approved for postoperative nausea and/or vomiting. First approved in 2006.

Drug data last refreshed 19h ago

Mechanism of Action

5-HT 3 receptor antagonist. While its mechanism of action has not been fully characterized, ondansetron is not a dopamine-receptor antagonist. Serotonin receptors of the 5-HT 3 type are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area…

Indications (1)

postoperative nausea and/or vomiting

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

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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.