Cardiotec

NDA 19928, held by Bracco. Technetium Tc-99m Teboroxime Kit.

As of Nov 13, 2026, NDA 19928 (Cardiotec), held by Bracco, was first approved by FDA on Dec 19, 1990, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 19, 1990
Review: Priority
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 19, 1990	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 17, 2003	Supplement 2Labeling · Standard review	Approved	Letter
Jan 9, 2002	Supplement 1Manufacturing · Priority review	Approved	Review
Dec 19, 1990	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19928
Drugs@FDA: Overview at FDA
Company: Bracco

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