Multihance

For abnormal blood-brain barrier or abnormal vascularity of the brain. NDA 21357, held by Bracco. Gadobenate Dimeglumine.

As of Nov 15, 2026, NDA 21357 (Multihance), held by Bracco, was first approved by FDA on Nov 23, 2004, with 17 approved supplements and 0 published complete response letters.

First approved: Nov 23, 2004
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and pediatric patients (including term neonates), to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues. magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Jan 19, 2018	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 6, 2012	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 17, 2010	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 23, 2004	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter Pediatric Medical Review

Products

4 strengths and forms


Multihance2.645GM/5ML (529MG/ML) · injectable;intravenous	Gadobenate Dimeglumine	RxReference drug
Multihance5.29GM/10ML (529MG/ML) · injectable;intravenous	Gadobenate Dimeglumine	RxReference drug
Multihance7.935GM/15ML (529MG/ML) · injectable;intravenous	Gadobenate Dimeglumine	RxReference drug
Multihance10.58GM/20ML (529MG/ML) · injectable;intravenous	Gadobenate Dimeglumine	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Mar 5, 2025	Supplement 28Labeling · Standard review	Approved	Label Medication Guide Letter
Aug 14, 2024	Supplement 26Labeling · Standard review	Approved	Label Letter
Jul 23, 2024	Supplement 27Labeling · Standard review	Approved	Label Letter
Jan 26, 2024	Supplement 25Labeling · Standard review	Approved	Label Letter
Nov 2, 2018	Supplement 18Labeling · Standard review	Approved	Letter Label
Apr 26, 2018	Supplement 17Labeling · Standard review	Approved	Letter Label
Apr 26, 2018	Supplement 16Labeling · Standard review	Approved	Letter Label
Jan 19, 2018	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 15, 2017	Supplement 15Labeling · Standard review	Approved	Letter Label
Jul 30, 2013	Supplement 13Labeling · Standard review	Approved	Label Letter
Jan 29, 2013	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 6, 2012	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 20, 2010	Supplement 9Labeling	Approved	Letter Label
Mar 17, 2010	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 2, 2009	Supplement 4Labeling · Standard review	Approved	Letter Label
Sep 4, 2007	Supplement 3Labeling · Standard review	Approved	Label Letter
May 8, 2007	Supplement 2Manufacturing	Approved	None posted
Nov 23, 2004	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter Pediatric Medical Review

Identifiers

Application: NDA 21357
Drugs@FDA: Overview at FDA
Company: Bracco

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