Gadobutrol

Used in scans for known or suspected coronary artery disease (CAD). ANDA 215061, held by Hengrui Pharma. Gadobutrol.

As of Nov 13, 2026, ANDA 215061 (Gadobutrol), held by Hengrui Pharma, was first approved by FDA on Nov 17, 2022, with 0 approved supplements and 0 published complete response letters.

First approved: Nov 17, 2022
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Gadobutrol injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI):

To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates
To assess the presence and extent of malignant breast disease in adult patients
To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates
To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Nov 17, 2022	Original application	Approved	Letter

Products

4 strengths and forms

Product	Active ingredient	Marketing
Gadobutrol1.20944GM/2ML (604.72MG/ML) · solution;intravenous	Gadobutrol	Rx
Gadobutrol4.5354GM/7.5ML (604.72MG/ML) · solution;intravenous	Gadobutrol	Rx
Gadobutrol6.0472GM/10ML (604.72MG/ML) · solution;intravenous	Gadobutrol	Rx
Gadobutrol9.0708GM/15ML (604.72MG/ML) · solution;intravenous	Gadobutrol	Rx

Identifiers

Application: ANDA 215061
Drugs@FDA: Overview at FDA
Company: Hengrui Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters