Data updated: Mar 10, 2026
ONDANSETRON
ONDANSETRON
Approved 2006-12-26
9
Indications
--
Phase 3 Trials
19
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2006-12-26
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING, INJECTABLE
Companies
NESHER PHARMS Novartis Aurobindo Pharma Teva PHARMOBEDIENT GLENMARK PHARMS LTD CHARTWELL MOLECULES Sun Pharma IPCA LABS LTD AM REGENT
Active Ingredient: ONDANSETRON
Website: ↗
ONDANSETRON Approval History
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What ONDANSETRON Treats
9 FDA approvalsOriginally approved for its first indication in 2006 . Covers 9 distinct patient populations.
- Other (9)
Other
(9 approvals)- • Approved indication (Dec 2006)Letter
- • Approved indication (Jun 2007)
- • Approved indication (Jun 2007)
- • Approved indication (Aug 2007)
- • Approved indication (Aug 2007)
- • Approved indication (Nov 2008)
- • Approved indication (Apr 2010)
- • Approved indication (Feb 2011)
- • Approved indication (Oct 2023)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ONDANSETRON FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.