Indiclor

NDA 19862, held by Ge Healthcare. Indium In-111 Chloride.

As of Nov 13, 2026, NDA 19862 (Indiclor), held by Ge Healthcare, was first approved by FDA on Dec 29, 1992, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 29, 1992
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


Oct 28, 1996	Supplement 3Efficacy (new indication or use)	Approved	None posted
Dec 29, 1992	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Indiclor2mCi/0.2ML · injectable;injection	Indium In-111 Chloride	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Jun 20, 2014	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 9, 2003	Supplement 14Labeling · Standard review	Approved	None posted
Apr 24, 2003	Supplement 12Labeling · Standard review	Approved	Letter Label
Feb 19, 2002	Supplement 6Labeling · Standard review	Approved	Letter Label
Oct 28, 1996	Supplement 3Efficacy (new indication or use)	Approved	None posted
Dec 29, 1992	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19862
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