Indium In 111 Oxyquinoline

NDA 19044, held by Ge Healthcare. Indium In-111 Oxyquinoline.

As of Nov 13, 2026, NDA 19044 (Indium In 111 Oxyquinoline), held by Ge Healthcare, was first approved by FDA on Dec 24, 1985, with 17 approved supplements and 0 published complete response letters.

First approved: Dec 24, 1985
Review: Priority
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Indium In 111 Oxyquinoline Solution is indicated for radiolabeling autologous leukocytes. Indium In 111 oxyquinoline labeled leukocytes may be used as an adjunct in the detection of inflammatory processes to which leukocytes migrate, such as those associated with abscesses or other infection, following reinjection and detection by appropriate imaging procedures. The degree of accuracy may vary with labeling techniques and with the size, location and nature of the inflammatory process.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Dec 24, 1985	Original applicationNew molecular entity · Priority review	Approved	Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Indium In 111 Oxyquinoline1mCi/ML · injectable;injection	Indium In-111 Oxyquinoline	RxReference drug

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 12, 2022	Supplement 25Labeling · Standard review	Approved	Letter Label
Jul 7, 2014	Supplement 23Manufacturing · Priority review	Approved	None posted
Nov 8, 2013	Supplement 22Manufacturing · Priority review	Approved	None posted
Sep 19, 2002	Supplement 18Labeling · Standard review	Approved	Review Letter
Aug 2, 2000	Supplement 16Manufacturing · Priority review	Approved	Review
Aug 30, 1999	Supplement 17Manufacturing · Priority review	Approved	Review
Oct 16, 1997	Supplement 15Labeling · Standard review	Approved	Review
Aug 11, 1995	Supplement 10Manufacturing · Priority review	Approved	Review
Aug 11, 1995	Supplement 11Manufacturing · Priority review	Approved	Review
Aug 11, 1995	Supplement 13Manufacturing · Priority review	Approved	Review
Jan 13, 1995	Supplement 12Manufacturing · Priority review	Approved	None posted
Aug 27, 1990	Supplement 9Manufacturing · Priority review	Approved	Review
Aug 8, 1990	Supplement 6Manufacturing · Priority review	Approved	Review
Aug 8, 1990	Supplement 8Manufacturing · Priority review	Approved	Review
Dec 12, 1989	Supplement 2Manufacturing · Priority review	Approved	Review
Apr 11, 1989	Supplement 5Labeling	Approved	Review
Jun 8, 1987	Supplement 3Manufacturing · Priority review	Approved	Review
Dec 24, 1985	Original applicationNew molecular entity · Priority review	Approved	Label

Identifiers

Application: NDA 19044
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