Technetium Tc-99m Pentetate Kit

NDA 17264, held by Ge Healthcare. Technetium Tc-99m Pentetate Kit.

As of Nov 13, 2026, NDA 17264 (Technetium Tc-99m Pentetate Kit), held by Ge Healthcare, was first approved by FDA on Feb 14, 1974, with 14 approved supplements and 0 published complete response letters.

First approved: Feb 14, 1974
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Feb 14, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Technetium Tc-99m Pentetate KitN/A · injectable;injection	Technetium Tc-99m Pentetate Kit	Discontinued

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 17, 1989	Supplement 25Manufacturing · Standard review	Approved	None posted
Dec 23, 1988	Supplement 24Manufacturing · Standard review	Approved	None posted
Oct 8, 1982	Supplement 20Labeling · Standard review	Approved	None posted
Sep 27, 1982	Supplement 21Labeling · Standard review	Approved	None posted
Aug 15, 1980	Supplement 18Labeling · Standard review	Approved	None posted
Sep 13, 1979	Supplement 14Labeling · Standard review	Approved	None posted
Sep 13, 1979	Supplement 13Labeling · Standard review	Approved	None posted
Sep 13, 1979	Supplement 12Labeling · Standard review	Approved	None posted
Sep 13, 1979	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 13, 1979	Supplement 9Labeling · Standard review	Approved	None posted
Apr 26, 1977	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 26, 1976	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 30, 1976	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 19, 1975	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 14, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17264
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