APPLICATION
ANDA218845
TYPE
ANDA
ORIGINAL APPROVAL
2025-10-10
LATEST ACTION
2025-10-10
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
GALLIUM GA 68 EDOTREOTIDEPrescription
GALLIUM GA-68 EDOTREOTIDE 0.5-4mCi/ML · SOLUTION · INTRAVENOUS
Approval history
2025-10-10UNKNOWN · 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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.