Technescan Mag3

Helps diagnose congenital and acquired abnormalities, renal failure, urinary tract…. NDA 19882, held by Curium. Technetium Tc-99m Mertiatide Kit.

As of Nov 13, 2026, NDA 19882 (Technescan Mag3), held by Curium, was first approved by FDA on Jun 15, 1990, with 8 approved supplements and 0 published complete response letters.

First approved: Jun 15, 1990
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Technetium Tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (See Pediatric Use. ) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Nov 27, 1992	Supplement 1Efficacy (new indication or use)	Approved	None posted
Jun 15, 1990	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Technescan Mag3N/A · injectable;injection	Technetium Tc-99m Mertiatide Kit	RxReference drug

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 28, 2014	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 16, 2001	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 8, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 11, 1994	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 11, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 26, 1993	Supplement 2Labeling	Approved	None posted
Nov 27, 1992	Supplement 1Efficacy (new indication or use)	Approved	None posted
Nov 27, 1992	Supplement 3Labeling	Approved	None posted
Jun 15, 1990	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19882
Drugs@FDA: Overview at FDA
Company: Curium

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters