← FDA DRUG APPROVALS

FDA ANDA · ANDA203936

SODIUM FLUORIDE F 18

sodium fluoride f-18

Sponsor: KREITCHMAN PET CTR

APPLICATION
ANDA203936
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-19
LATEST ACTION
2016-05-19
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SODIUM FLUORIDE F-18Prescription
SODIUM FLUORIDE F-18 10-200mCi/ML · INJECTABLE · INTRAVENOUS

Approval history

2016-05-19UNKNOWN · OriginalAP
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 →