Ceretec

NDA 19829, held by Ge Healthcare. Technetium Tc-99m Exametazime Kit.

As of Nov 13, 2026, NDA 19829 (Ceretec), held by Ge Healthcare, was first approved by FDA on Dec 30, 1988, with 17 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1988
Review: Priority
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Technetium Tc99m exametazime scintigraphy may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke. Tc99m exametazime is indicated for leukocyte labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Apr 7, 1995	Supplement 5Efficacy (new indication or use)	Approved	None posted
Dec 30, 1988	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
CeretecN/A · injectable;injection	Technetium Tc-99m Exametazime Kit	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Sep 19, 2018	Supplement 34Labeling · Standard review	Approved	Letter Label
Apr 8, 2016	Supplement 28Manufacturing · Priority review	Approved	None posted
Jun 27, 2014	Supplement 27Manufacturing · Priority review	Approved	None posted
Aug 5, 2013	Supplement 26Labeling · Standard review	Approved	Letter Label
Mar 8, 2013	Supplement 25Manufacturing · Priority review	Approved	None posted
Jun 15, 2005	Supplement 19Labeling · Standard review	Approved	Letter
Nov 25, 2002	Supplement 14Manufacturing · Priority review	Approved	None posted
Aug 17, 2001	Supplement 13Manufacturing · Priority review	Approved	None posted
Apr 10, 2001	Supplement 12Manufacturing · Priority review	Approved	None posted
Sep 29, 2000	Supplement 11Manufacturing · Priority review	Approved	None posted
Nov 12, 1999	Supplement 10Manufacturing · Priority review	Approved	None posted
Nov 27, 1996	Supplement 9Manufacturing · Priority review	Approved	None posted
Apr 7, 1995	Supplement 6Manufacturing · Priority review	Approved	None posted
Apr 7, 1995	Supplement 5Efficacy (new indication or use)	Approved	None posted
Apr 7, 1995	Supplement 4Manufacturing · Priority review	Approved	None posted
Jul 25, 1994	Supplement 8Manufacturing · Priority review	Approved	None posted
Mar 2, 1993	Supplement 1Manufacturing · Priority review	Approved	None posted
Dec 30, 1988	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19829
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