Cardiogen-82

Used in scans for suspected or existing coronary artery disease. NDA 19414, held by Bracco. Rubidium Chloride Rb-82.

As of Nov 13, 2026, NDA 19414 (Cardiogen-82), held by Bracco, was first approved by FDA on Dec 29, 1989, with 16 approved supplements and 0 published complete response letters.

First approved: Dec 29, 1989
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CardioGen-82, used to produce Rubidium Chloride Rb 82 Injection, is indicated for positron emission tomography (PET) of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Dec 23, 2024	Supplement 34Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 15, 2020	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 29, 2010	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 29, 1989	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cardiogen-82N/A · injectable;injection	Rubidium Chloride Rb-82	Rx

All 17 submissions, including labeling and manufacturing supplements


May 13, 2026	Supplement 38Labeling · Standard review	Approved	Label Letter
Dec 23, 2024	Supplement 34Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 15, 2020	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 24, 2019	Supplement 24Labeling · Standard review	Approved	Label Letter
Apr 26, 2019	Supplement 22Labeling · Standard review	Approved	Letter Label
Dec 5, 2014	Supplement 16Manufacturing · Standard review	Approved	None posted
Apr 22, 2013	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 8, 2012	Supplement 14Labeling · Standard review	Approved	Letter Label
Jul 29, 2010	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 21, 2009	Supplement 11Labeling · Standard review	Approved	Letter Label
Apr 5, 2001	Supplement 6Manufacturing · Standard review	Approved	Letter
Mar 23, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
May 29, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 21, 1997	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 14, 1991	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 6, 1990	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 29, 1989	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19414
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