Thallous Chloride Tl 201

NDA 18110, held by Ge Healthcare. Thallous Chloride Tl-201.

As of Nov 15, 2026, NDA 18110 (Thallous Chloride Tl 201), held by Ge Healthcare, was first approved by FDA on Feb 1, 1982, with 12 approved supplements and 0 published complete response letters.

First approved: Feb 1, 1982
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Feb 1, 1982	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	DiscontinuedReference drug

All 13 submissions, including labeling and manufacturing supplements


Jun 8, 2016	Supplement 16Manufacturing · Standard review	Approved	None posted
May 12, 2005	Supplement 12Labeling · Standard review	Approved	Letter
Nov 14, 2002	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 22, 2002	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 10, 2001	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 27, 1996	Supplement 6Labeling · Standard review	Approved	None posted
Nov 8, 1995	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 3, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 13, 1990	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 6, 1990	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 28, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 26, 1982	Supplement 2Labeling	Approved	None posted
Feb 1, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18110
Drugs@FDA: Overview at FDA
Company: GE Healthcare

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