← FDA DRUG APPROVALS

FDA ANDA · ANDA219189

GALLIUM GA-68 PSMA-11

gallium ga-68 gozetotide

Sponsor: IONETIX

APPLICATION
ANDA219189
TYPE
ANDA
ORIGINAL APPROVAL
2026-05-14
LATEST ACTION
2026-05-14
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

GALLIUM GA 68 GOZETOTIDEPrescription
GALLIUM GA-68 GOZETOTIDE 0.5-5mCi/ML · SOLUTION · INTRAVENOUS

Approval history

2026-05-14UNKNOWN · Original · standard — Letter ↗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 →