What is GADOTERATE MEGLUMINE used for?

GADOTERATE MEGLUMINE is an FDA-approved medication. See full prescribing information for approved uses.

Is GADOTERATE MEGLUMINE FDA approved?

Yes, GADOTERATE MEGLUMINE is FDA approved (first approved 2022-04-11) and manufactured by HENGRUI PHARMA.

Who makes GADOTERATE MEGLUMINE?

GADOTERATE MEGLUMINE is manufactured by HENGRUI PHARMA.

Data updated: Mar 10, 2026

GADOTERATE MEGLUMINE

Approved 2022-04-11

Jump to: Indications Approvals Trials Competitors Safety Patents

Indications

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 2022-04-11
Routes: INTRAVENOUS
Dosage Forms: SOLUTION

Companies

HENGRUI PHARMA HAINAN POLY

Active Ingredient: GADOTERATE MEGLUMINE

GADOTERATE MEGLUMINE Approval History

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What GADOTERATE MEGLUMINE Treats

2 FDA approvals

Originally approved for its first indication in 2022 . Covers 2 distinct patient populations.

Other (2)

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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.

GADOTERATE MEGLUMINE FDA Label Details

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Data Sources

FDA Approval: ANDA215304 → Trials: ClinicalTrials.gov →

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