Gadobutrol

Used in scans for known or suspected coronary artery disease (CAD). ANDA 216081, held by Hengrui Pharma. Gadobutrol.

As of Nov 15, 2026, ANDA 216081 (Gadobutrol), held by Hengrui Pharma, was first approved by FDA on Sep 8, 2023, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 8, 2023
Review: Standard
Supplements approved: 3
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; all 4 submissions below

Date	Submission	Status	Documents
Sep 8, 2023	Original application	Approved	Letter

Products

6 strengths and forms


Gadobutrol18.1416GM/30ML (604.72MG/ML) · solution;intravenous	Gadobutrol	Rx
Gadobutrol39.3068GM/65ML (604.72MG/ML) · solution;intravenous	Gadobutrol	Rx
Gadobutrol1.20944GM/2ML (604.72MG/ML) · solution;intravenous	Gadobutrol	Discontinued
Gadobutrol4.5354GM/7.5ML (604.72MG/ML) · solution;intravenous	Gadobutrol	Discontinued
Gadobutrol6.0472GM/10ML (604.72MG/ML) · solution;intravenous	Gadobutrol	Discontinued
Gadobutrol9.0708GM/15ML (604.72MG/ML) · solution;intravenous	Gadobutrol	Discontinued

All 4 submissions, including labeling and manufacturing supplements


May 1, 2026	Supplement 7Labeling · Standard review	Approved	None posted
May 1, 2026	Supplement 9Labeling · Standard review	Approved	None posted
Aug 19, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Sep 8, 2023	Original application	Approved	Letter

Identifiers

Application: ANDA 216081
Drugs@FDA: Overview at FDA
Company: Hengrui Pharma

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