TheraRadar
Data updated: Jul 17, 2026

AMBELVIST (gadoquatrane) · Bayer

Approved 2026-06-12
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2026-06-12
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Bayer
Active Ingredient: GADOQUATRANE

AMBELVIST Approval History

Original
New Indication
New Form
Label Update
6 FDA actions from 2026 to 2026
Jun 2026 ORIGINAL
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What AMBELVIST Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • 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.

AMBELVIST FDA Label Details

Track AMBELVIST with TheraRadar Pro

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

Upgrade to Pro

Data Sources

FDA Approval: NDA219627 → Trials: ClinicalTrials.gov →

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