← FDA DRUG APPROVALS

FDA NDA · NDA204677

NEURACEQ

florbetaben f 18

Sponsor: LANTHEUS

APPLICATION
NDA204677
TYPE
NDA
ORIGINAL APPROVAL
2014-03-19
LATEST ACTION
2026-07-22
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

NEURACEQ · ReferencePrescription
FLORBETABEN F-18 1.4-135mCi/ML · SOLUTION · INTRAVENOUS

Approval history

2026-07-22Labeling · Supplement 41 · standard — Letter ↗AP
2025-06-23Labeling · Supplement 34 · standard — Label ↗AP
2025-06-23Efficacy · Supplement 24 · unknown — Label ↗AP
2023-10-31Labeling · Supplement 23 · standard — Label ↗AP
2022-06-08Manufacturing (CMC) · Supplement 21 — Letter ↗AP
2020-01-10Labeling · Supplement 19 · standard — Letter ↗AP
2018-07-10Manufacturing (CMC) · Supplement 15AP
2017-06-16Labeling · Supplement 14 · standard — Label ↗AP
2016-10-03Labeling · Supplement 11 · standard — Letter ↗AP
2016-08-25Labeling · Supplement 12 · standard — Letter ↗AP
2016-03-08Manufacturing (CMC) · Supplement 13 · standardAP
2016-01-25Manufacturing (CMC) · Supplement 9 · standardAP
2015-05-19Manufacturing (CMC) · Supplement 6 · standardAP
2015-05-18Manufacturing (CMC) · Supplement 7 · standardAP
2015-05-04Manufacturing (CMC) · Supplement 5 · standardAP
2014-10-15Manufacturing (CMC) · Supplement 3 · standardAP
2014-10-15Manufacturing (CMC) · Supplement 2 · standardAP
2014-08-13Manufacturing (CMC) · Supplement 4 · standardAP
2014-04-04Labeling · Supplement 1 · standard — Label ↗AP
2014-03-19Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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