Prohance Multipack

Used in scans for disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions). NDA 21489, held by Bracco. Gadoteridol.

As of Nov 14, 2026, NDA 21489 (Prohance Multipack), held by Bracco, was first approved by FDA on Oct 9, 2003, with 14 approved supplements and 0 published complete response letters.

First approved: Oct 9, 2003
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ProHance Multipack is a gadolinium-based contrast agent indicated for magnetic resonance imaging (MRI) to visualize: lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients, including term neonates lesions in the head and neck in adults 1.1 MRI of the Central Nervous System (CNS) ProHance is indicated for magnetic resonance imaging (MRI) in adults and pediatric patients including term neonates to visualize lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below


Dec 19, 2020	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 9, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prohance Multipack279.3MG/ML · injectable;injection	Gadoteridol	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


Mar 5, 2025	Supplement 25Labeling · Standard review	Approved	Label Letter
Aug 14, 2024	Supplement 23Labeling · Standard review	Approved	Label Medication Guide Letter
Jul 23, 2024	Supplement 24Labeling · Standard review	Approved	Label Letter
Jan 26, 2024	Supplement 21Labeling · Standard review	Approved	Label Letter
Nov 19, 2022	Supplement 18Labeling · Standard review	Approved	Label Letter
May 6, 2021	Supplement 16Labeling · Standard review	Approved	Label Letter
Dec 19, 2020	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 2, 2018	Supplement 10Labeling · Standard review	Approved	Letter Label
Apr 26, 2018	Supplement 6Labeling · Standard review	Approved	Letter Label
Sep 15, 2017	Supplement 5Labeling · Standard review	Approved	Label Letter
Jul 22, 2014	Supplement 4Labeling · Standard review	Approved	Letter Label
Aug 13, 2013	Supplement 3Labeling · Standard review	Approved	Letter Label
Dec 20, 2010	Supplement 2Labeling	Approved	Letter Label
Sep 4, 2007	Supplement 1Labeling · Standard review	Approved	Letter Label
Oct 9, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21489
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