Mpi Dmsa Kidney Reagent

NDA 17944, held by Ge Healthcare. Technetium Tc-99m Succimer Kit.

As of Nov 14, 2026, NDA 17944 (Mpi Dmsa Kidney Reagent), held by Ge Healthcare, was first approved by FDA on May 18, 1982, with 18 approved supplements and 0 published complete response letters.

First approved: May 18, 1982
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
May 18, 1982	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mpi Dmsa Kidney ReagentN/A Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Technetium Tc-99m Succimer Kit	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements


Feb 28, 2014	Supplement 24Manufacturing · Standard review	Approved	None posted
Nov 22, 2013	Supplement 23Manufacturing · Standard review	Approved	None posted
Nov 24, 2003	Supplement 18Labeling · Standard review	Approved	Letter
Nov 25, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
Apr 10, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 29, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 12, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 16, 1995	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 17, 1994	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 15, 1993	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 15, 1989	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 17, 1989	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 17, 1989	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 10, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 23, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 12, 1985	Supplement 5Labeling	Approved	None posted
Jan 30, 1985	Supplement 4Manufacturing · Standard review	Approved	None posted
May 27, 1983	Supplement 2Labeling	Approved	None posted
May 18, 1982	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 17944
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