← FDA DRUG APPROVALS

FDA NDA · NDA202008

AMYVID

florbetapir f 18

Sponsor: AVID RADIOPHARMS INC

APPLICATION
NDA202008
TYPE
NDA
ORIGINAL APPROVAL
2012-04-06
LATEST ACTION
2025-06-23
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

AMYVID · ReferencePrescription
FLORBETAPIR F-18 10-50ML (13.5-51mCi/ML) · SOLUTION · INTRAVENOUS
AMYVID · ReferenceDiscontinued
FLORBETAPIR F-18 10ML (13.5-51mCi/ML) · SOLUTION · INTRAVENOUS
AMYVID · ReferencePrescription
FLORBETAPIR F-18 10-100ML (13.5-51mCi/ML) · SOLUTION · INTRAVENOUS
AMYVID · ReferenceDiscontinued
FLORBETAPIR F-18 10-30ML (13.5-51mCi/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-06-23Efficacy · Supplement 46 · standard — Label ↗AP
2023-10-13Manufacturing (CMC) · Supplement 44 — Label ↗AP
2022-08-19Manufacturing (CMC) · Supplement 41 — Letter ↗AP
2019-12-20Labeling · Supplement 36 · standard — Label ↗AP
2016-06-22Manufacturing (CMC) · Supplement 26 · priorityAP
2016-03-09Manufacturing (CMC) · Supplement 25 · priorityAP
2015-07-09Manufacturing (CMC) · Supplement 24 · priorityAP
2015-07-09Manufacturing (CMC) · Supplement 22 · priorityAP
2015-06-25Manufacturing (CMC) · Supplement 23 · priorityAP
2014-03-14Manufacturing (CMC) · Supplement 21 · priorityAP
2013-12-12Labeling · Supplement 20 · unknown — Letter ↗AP
2013-11-08Manufacturing (CMC) · Supplement 19 · priorityAP
2013-10-25Manufacturing (CMC) · Supplement 18 · priorityAP
2013-03-27Manufacturing (CMC) · Supplement 15 · priorityAP
2013-03-22Manufacturing (CMC) · Supplement 14 · priorityAP
2013-03-22Manufacturing (CMC) · Supplement 17 · priorityAP
2013-03-13Manufacturing (CMC) · Supplement 9 · priorityAP
2013-03-06Manufacturing (CMC) · Supplement 16 · priorityAP
2013-03-06Manufacturing (CMC) · Supplement 12 · priorityAP
2013-03-06Manufacturing (CMC) · Supplement 13 · priorityAP
2013-02-19Manufacturing (CMC) · Supplement 11 · priorityAP
2013-02-19Manufacturing (CMC) · Supplement 10 · priorityAP
2013-02-19Manufacturing (CMC) · Supplement 7 · priorityAP
2013-01-18Manufacturing (CMC) · Supplement 8 · priorityAP
2013-01-18Manufacturing (CMC) · Supplement 6 · priorityAP
2012-04-06Type 1 - New Molecular Entity · Original · priority — Review ↗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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