FDA NDA · NDA017707

INDIUM DTPA IN 111

indium in-111 pentetate disodium

Sponsor: GE HEALTHCARE

APPLICATION

NDA017707

TYPE

NDA

ORIGINAL APPROVAL

1982-02-18

LATEST ACTION

2016-12-22

ROUTE

INTRATHECAL

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

MPI INDIUM DTPA IN 111 · ReferencePrescription

INDIUM IN-111 PENTETATE DISODIUM 1mCi/ML · INJECTABLE · INTRATHECAL

2016-12-22Manufacturing (CMC) · Supplement 12 · standardAP

2004-09-21Labeling · Supplement 10 · standard — Letter ↗AP

2002-04-30Manufacturing (CMC) · Supplement 8 · standardAP

1996-01-30Labeling · Supplement 7 · standardAP

1995-05-19Manufacturing (CMC) · Supplement 5 · standardAP

1995-02-28Manufacturing (CMC) · Supplement 6 · standardAP

1985-05-22Labeling · Supplement 3AP

1984-09-27Manufacturing (CMC) · Supplement 2 · standardAP

1982-02-18Type 1 - New Molecular Entity · Original · standardAP

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.