← FDA DRUG APPROVALS

FDA NDA · NDA022454

DATSCAN

ioflupane i-123

Sponsor: GE HLTHCARE INC

APPLICATION
NDA022454
TYPE
NDA
ORIGINAL APPROVAL
2011-01-14
LATEST ACTION
2026-04-15
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

DATSCAN · ReferencePrescription
IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-04-15Labeling · Supplement 17 · standard — Letter ↗AP
2022-11-30Labeling · Supplement 11 · standard — Letter ↗AP
2022-11-01Efficacy · Supplement 10 · standard — Letter ↗AP
2020-03-25Labeling · Supplement 7 · standard — Letter ↗AP
2015-09-11Labeling · Supplement 4 · standard — Label ↗AP
2011-01-14Type 1 - New Molecular Entity · Original · priority — Label ↗AP
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 →