FDA NDA · NDA019841

INDIUM IN 111 CHLORIDE

Sponsor: CURIUM

APPLICATION

NDA019841

TYPE

NDA

ORIGINAL APPROVAL

1994-09-27

LATEST ACTION

2017-01-26

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued

Products

INDIUM IN 111 CHLORIDE · ReferenceDiscontinued

INDIUM IN-111 CHLORIDE 5mCi/0.5ML · INJECTABLE · INJECTION

2017-01-26Manufacturing (CMC) · Supplement 12 · standardAP

2002-02-19Labeling · Supplement 3 · standard — Label ↗AP

1996-10-28Labeling · Supplement 1 · standardAP

1996-07-03Labeling · Supplement 2 · standardAP

1994-09-27Type 1 - New Molecular Entity · Original · priorityAP

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

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