Technetium Tc 99m Tsc

NDA 17784, held by Ge Healthcare. Technetium Tc-99m Sulfur Colloid Kit.

As of Nov 14, 2026, NDA 17784 (Technetium Tc 99m Tsc), held by Ge Healthcare, was first approved by FDA on Nov 18, 1976, with 15 approved supplements and 0 published complete response letters.

First approved: Nov 18, 1976
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Jul 2, 1987	Supplement 15Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 18, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Technetium Tc 99m TscN/A · solution;injection, oral	Technetium Tc-99m Sulfur Colloid Kit	Discontinued

All 16 submissions, including labeling and manufacturing supplements


Feb 17, 1989	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 23, 1988	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 15, 1988	Supplement 19Labeling · Standard review	Approved	None posted
Jul 2, 1987	Supplement 15Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 19, 1985	Supplement 14Labeling · Standard review	Approved	None posted
Dec 7, 1982	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 7, 1982	Supplement 13Labeling · Standard review	Approved	None posted
Aug 12, 1982	Supplement 10Labeling · Standard review	Approved	None posted
Apr 27, 1981	Supplement 11Labeling · Standard review	Approved	None posted
Oct 9, 1979	Supplement 6Labeling · Standard review	Approved	None posted
Aug 28, 1978	Supplement 7Labeling · Standard review	Approved	None posted
Sep 13, 1977	Supplement 3Labeling · Standard review	Approved	None posted
Sep 12, 1977	Supplement 4Labeling · Standard review	Approved	None posted
Aug 9, 1977	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 9, 1977	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 18, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17784
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