Sodium Pertechnetate Tc 99m

NDA 17471, held by Ge Healthcare. Technetium Tc-99m Sodium Pertechnetate.

As of Nov 13, 2026, NDA 17471 (Sodium Pertechnetate Tc 99m), held by Ge Healthcare, was first approved by FDA on Jul 18, 1974, with 6 approved supplements and 0 published complete response letters.

First approved: Jul 18, 1974
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


Feb 2, 1983	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Jul 18, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sodium Pertechnetate Tc 99m2-100mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;injection, oral	Technetium Tc-99m Sodium Pertechnetate	DiscontinuedReference drug

All 7 submissions, including labeling and manufacturing supplements


Feb 2, 1983	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Jul 20, 1979	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 22, 1979	Supplement 10Labeling · Standard review	Approved	None posted
Feb 21, 1978	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 24, 1977	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 17, 1977	Supplement 5Labeling · Standard review	Approved	None posted
Jul 18, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17471
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