Thallous Chloride Tl 201

Helps diagnose coronary artery disease. NDA 18150, held by Curium. Thallous Chloride Tl-201.

As of Nov 13, 2026, NDA 18150 (Thallous Chloride Tl 201), held by Curium, was first approved by FDA on Oct 23, 1979, with 17 approved supplements and 0 published complete response letters.

First approved: Oct 23, 1979
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Thallous Chloride Tl 201 Injection is indicated for use with planar scintigraphy or single-photon emission computed tomography (SPECT) for the following applications: Myocardial perfusion imaging in adults for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction) Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress Localization of sites of parathyroid hyperactivity pre- and post-operatively in adults with elevated serum calcium and parathyroid hormone levels

Full prescribing information on DailyMed ↗

Approvals and New Uses

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


Jul 23, 2004	Supplement 19Efficacy (new indication or use)	Approved	Review Letter Label
Dec 16, 1993	Supplement 10Efficacy (new indication or use)	Approved	None posted
Oct 23, 1979	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thallous Chloride Tl 2011mCi/ML · injectable;injection	Thallous Chloride Tl-201	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Dec 10, 2025	Supplement 29Labeling · Standard review	Approved	Label Letter
Jul 13, 2016	Supplement 27Labeling · Standard review	Approved	Label Letter
Jan 12, 2012	Supplement 26Labeling	Approved	Label Letter
Jun 22, 2011	Supplement 25Labeling	Approved	Label Letter
Jul 23, 2004	Supplement 19Efficacy (new indication or use)	Approved	Review Letter Label
Apr 16, 2004	Supplement 20Manufacturing · Standard review	Approved	Letter
Sep 27, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 3, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 22, 1999	Supplement 13Labeling · Standard review	Approved	None posted
Feb 18, 1997	Supplement 12Labeling · Standard review	Approved	None posted
Mar 30, 1994	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 16, 1993	Supplement 10Efficacy (new indication or use)	Approved	None posted
Jul 13, 1988	Supplement 9Labeling	Approved	None posted
Sep 12, 1984	Supplement 6Manufacturing · Standard review	Approved	None posted
May 7, 1982	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 27, 1981	Supplement 5Manufacturing · Standard review	Approved	None posted
May 13, 1980	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 23, 1979	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18150
Drugs@FDA: Overview at FDA
Company: Curium

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