Multihance Multipack

For abnormal blood-brain barrier or abnormal vascularity of the brain. NDA 21358, held by Bracco. Gadobenate Dimeglumine.

As of Nov 14, 2026, NDA 21358 (Multihance Multipack), held by Bracco, was first approved by FDA on Nov 23, 2004, with 16 approved supplements and 0 published complete response letters.

First approved: Nov 23, 2004
Review: Standard
Supplements approved: 16
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 17 submissions below


Jan 19, 2018	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 6, 2012	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 23, 2004	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

2 strengths and forms


Multihance Multipack26.45GM/50ML (529MG/ML) · injectable;intravenous	Gadobenate Dimeglumine	RxReference drug
Multihance Multipack52.9GM/100ML (529MG/ML) · injectable;intravenous	Gadobenate Dimeglumine	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Mar 5, 2025	Supplement 26Labeling · Standard review	Approved	Label Medication Guide Letter
Aug 14, 2024	Supplement 24Labeling · Standard review	Approved	Label Letter
Jul 23, 2024	Supplement 25Labeling · Standard review	Approved	Label Letter
Jan 26, 2024	Supplement 23Labeling · Standard review	Approved	Letter Label
Nov 2, 2018	Supplement 17Labeling · Standard review	Approved	Letter Label
Apr 26, 2018	Supplement 16Labeling · Standard review	Approved	Letter Label
Apr 26, 2018	Supplement 15Labeling · Standard review	Approved	Letter Label
Jan 19, 2018	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 15, 2017	Supplement 14Labeling · Standard review	Approved	Letter Label
Jul 30, 2013	Supplement 12Labeling · Standard review	Approved	Label Letter
Jan 29, 2013	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 6, 2012	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 29, 2011	Supplement 10Labeling	Approved	Letter
Feb 16, 2011	Supplement 8Labeling	Approved	Label Letter
Sep 4, 2007	Supplement 3Labeling · Standard review	Approved	Letter Label
May 8, 2007	Supplement 2Manufacturing	Approved	None posted
Nov 23, 2004	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21358
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