TheraRadar
Data updated: May 26, 2026

ANZEMET (dolasetron mesylate)

Gastrointestinal Approved 1997-09-11
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
28
Years on Market

Details

Status
Discontinued
First Approved
1997-09-11
Routes
ORAL, INJECTION
Dosage Forms
TABLET, INJECTABLE

Companies

VALIDUS PHARMS
Active Ingredient: DOLASETRON MESYLATE

ANZEMET Approval History

1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
78 FDA actions from 1997 to 2014
Sep 2014 SUPPL
Label · Labeling
FDA Letter Label
Sep 2013 SUPPL
Mfg · Manufacturing (CMC)
Sep 2013 SUPPL
Label · Labeling
FDA Letter Label

What ANZEMET Treats

1 FDA approvals

Originally approved for its first indication in 1997 .

  • Other (1)
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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.

ANZEMET FDA Label Details

Track ANZEMET with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: NDA020623 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.