← FDA DRUG APPROVALS

FDA NDA · NDA212155

CERIANNA

fluoroestradiol f 18

Sponsor: GE HEALTHCARE

APPLICATION
NDA212155
TYPE
NDA
ORIGINAL APPROVAL
2020-05-20
LATEST ACTION
2024-05-06
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

CERIANNA · ReferencePrescription
FLUOROESTRADIOL F-18 50ML (4-100mCi/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-05-06Labeling · Supplement 21 · standard — Letter ↗AP
2022-04-06Labeling · Supplement 14 · standardAP
2020-05-20Type 1 - New Molecular Entity · Original · standard — 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 →