← FDA DRUG APPROVALS

FDA NDA · NDA020899

OPTISON PERFLUTREN PROTEIN-TYPE A MICROSPHERES

human albumin microspheres and perflutren

Sponsor: GE HEALTHCARE

APPLICATION
NDA020899
TYPE
NDA
ORIGINAL APPROVAL
1997-12-31
LATEST ACTION
2025-05-09
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

OPTISON · ReferencePrescription
ALBUMIN HUMAN 10MG/ML · INJECTABLE · INJECTION

Approval history

2025-05-09Efficacy · Supplement 25 · standard — Letter ↗AP
2021-09-16Labeling · Supplement 24 · standard — Letter ↗AP
2021-09-01Labeling · Supplement 23 · standard — Letter ↗AP
2016-09-16Labeling · Supplement 18 · standard — Label ↗AP
2016-09-16Labeling · Supplement 19 · standard — Label ↗AP
2016-04-15Manufacturing (CMC) · Supplement 17 · standardAP
2013-11-15Manufacturing (CMC) · Supplement 16 · standardAP
2012-08-17Efficacy · Supplement 15 · standard — Label ↗AP
2008-06-06Labeling · Supplement 11 · standard — Letter ↗AP
2007-11-08Labeling · Supplement 10 · standard — Letter ↗AP
2002-05-10Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP
2000-12-18Manufacturing (CMC) · Supplement 6 · standardAP
2000-03-14Labeling · Supplement 3 · standardAP
2000-02-04Manufacturing (CMC) · Supplement 4 · standardAP
1999-05-06Manufacturing (CMC) · Supplement 5 · standardAP
1999-02-01Manufacturing (CMC) · Supplement 2 · standardAP
1998-07-31Manufacturing (CMC) · Supplement 1 · standardAP
1997-12-31Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗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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