← FDA DRUG APPROVALS

FDA NDA · NDA021064

DEFINITY

perflutren

Sponsor: LANTHEUS MEDCL

APPLICATION
NDA021064
TYPE
NDA
ORIGINAL APPROVAL
2001-07-31
LATEST ACTION
2024-03-01
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DEFINITY · ReferencePrescription
PERFLUTREN 13.04MG/2ML (6.52MG/ML) · INJECTABLE · INTRAVENOUS
DEFINITY RT · ReferencePrescription
PERFLUTREN 13.04MG/2ML (6.52MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2024-03-01Efficacy · Supplement 33 · standard — Label ↗AP
2023-06-05Labeling · Supplement 32 · standard — Label ↗AP
2021-04-09Labeling · Supplement 29 · standard — Label ↗AP
2021-04-09Labeling · Supplement 25 · standard — Label ↗AP
2020-11-17Labeling · Supplement 24 · standard — Letter ↗AP
2020-07-30Labeling · Supplement 23 · standard — Letter ↗AP
2018-12-12Labeling · Supplement 22 · standard — Letter ↗AP
2018-04-13Manufacturing (CMC) · Supplement 21AP
2017-01-19Labeling · Supplement 20 · standard — Letter ↗AP
2015-11-23Manufacturing (CMC) · Supplement 18 · standardAP
2015-08-18Labeling · Supplement 17 · standard — Label ↗AP
2013-02-05Manufacturing (CMC) · Supplement 16 · standardAP
2011-10-24Efficacy · Supplement 11 · standard — Summary Review ↗AP
2008-05-12Labeling · Supplement 9 · standard — Letter ↗AP
2007-10-10Labeling · Supplement 7 · standard — Letter ↗AP
2005-05-06Labeling · Supplement 6 · standard — Label ↗AP
2003-01-30Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP
2002-07-08Labeling · Supplement 2 · standard — Letter ↗AP
2002-02-21Labeling · Supplement 1 · standard — Letter ↗AP
2001-07-31Type 1 - New Molecular Entity · Original · standard — Review ↗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 →