TheraRadar
Data updated: May 26, 2026

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE (granisetron hydrochloride)

Oncology Approved 2007-12-31

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE is indicated for the treatment of Nausea; Vomiting.

Source: FDA Label • Fresenius Kabi
2
Indications
--
Phase 3 Trials
18
Years on Market

Details

Status
Prescription
First Approved
2007-12-31
Routes
INJECTION
Dosage Forms
INJECTABLE

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE Approval History

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
8 FDA actions from 2007 to 2022
May 2022 SUPPL
Label · Labeling
Sep 2014 SUPPL
Label · Labeling
Feb 2013 SUPPL
Label · Labeling

What GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE Treats

2 indications

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE is approved for 2 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Nausea
  • Vomiting
Source: FDA Label

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT03924518 GRANTISS 2018-ZZJHZX-009 Ph 2 completed Adjunctive Granisetron Therapy in Patients With Sepsis or Septic Shock
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Active Pipeline

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Key Completed Trials

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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.

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE FDA Label Details

Indications & Usage

FDA Label (PDF)

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE is indicated for the treatment of Nausea; Vomiting.

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Data Sources

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