← FDA DRUG APPROVALS

FDA NDA · NDA019044

INDIUM IN 111 OXYQUINOLINE

indium in-111 oxyquinoline

Sponsor: GE HEALTHCARE

APPLICATION
NDA019044
TYPE
NDA
ORIGINAL APPROVAL
1985-12-24
LATEST ACTION
2022-12-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

INDIUM IN 111 OXYQUINOLINE · ReferencePrescription
INDIUM IN-111 OXYQUINOLINE 1mCi/ML · INJECTABLE · INJECTION

Approval history

2022-12-12Labeling · Supplement 25 · standard — Letter ↗AP
2014-07-07Manufacturing (CMC) · Supplement 23 · priorityAP
2013-11-08Manufacturing (CMC) · Supplement 22 · priorityAP
2002-09-19Labeling · Supplement 18 · standard — Review ↗AP
2000-08-02Manufacturing (CMC) · Supplement 16 · priority — Review ↗AP
1999-08-30Manufacturing (CMC) · Supplement 17 · priority — Review ↗AP
1997-10-16Labeling · Supplement 15 · standard — Review ↗AP
1995-08-11Manufacturing (CMC) · Supplement 13 · priority — Review ↗AP
1995-08-11Manufacturing (CMC) · Supplement 11 · priority — Review ↗AP
1995-08-11Manufacturing (CMC) · Supplement 10 · priority — Review ↗AP
1995-01-13Manufacturing (CMC) · Supplement 12 · priorityAP
1990-08-27Manufacturing (CMC) · Supplement 9 · priority — Review ↗AP
1990-08-08Manufacturing (CMC) · Supplement 8 · priority — Review ↗AP
1990-08-08Manufacturing (CMC) · Supplement 6 · priority — Review ↗AP
1989-12-12Manufacturing (CMC) · Supplement 2 · priority — Review ↗AP
1989-04-11Labeling · Supplement 5 — Review ↗AP
1987-06-08Manufacturing (CMC) · Supplement 3 · priority — Review ↗AP
1985-12-24Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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