← FDA DRUG APPROVALS

FDA NDA · NDA019862

INDICLOR

Sponsor: GE HEALTHCARE

APPLICATION
NDA019862
TYPE
NDA
ORIGINAL APPROVAL
1992-12-29
LATEST ACTION
2014-06-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

INDICLOR · ReferenceDiscontinued
INDIUM IN-111 CHLORIDE 2mCi/0.2ML · INJECTABLE · INJECTION

Approval history

2014-06-20Manufacturing (CMC) · Supplement 21 · standardAP
2003-07-09Labeling · Supplement 14 · standardAP
2003-04-24Labeling · Supplement 12 · standard — Letter ↗AP
2002-02-19Labeling · Supplement 6 · standard — Label ↗AP
1996-10-28Efficacy · Supplement 3 · unknownAP
1992-12-29Type 1 - New Molecular Entity · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →