Glucoscan

NDA 17907, held by Bristol Myers Squibb. Technetium Tc-99m Gluceptate Kit.

As of Nov 13, 2026, NDA 17907 (Glucoscan), held by Bristol Myers Squibb, was first approved by FDA on May 25, 1978, with 5 approved supplements and 0 published complete response letters.

First approved: May 25, 1978
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
May 25, 1978	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 7, 2007	Supplement 1Labeling	Approved	None posted
Dec 7, 2007	Supplement 5Labeling	Approved	None posted
Mar 26, 1990	Supplement 11Manufacturing · Standard review	Approved	None posted
May 2, 1989	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 19, 1983	Supplement 8Manufacturing · Standard review	Approved	None posted
May 25, 1978	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 17907
Drugs@FDA: Overview at FDA
Company: Bristol-Myers Squibb

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