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FDA NDA · NDA203684

LUMASON

sulfur hexafluoride

Sponsor: BRACCO

APPLICATION
NDA203684
TYPE
NDA
ORIGINAL APPROVAL
2014-10-10
LATEST ACTION
2021-04-09
ROUTE
INTRAVENOUS, INTRAVESICAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

LUMASON · ReferencePrescription
SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES 60.7MG/25MG · FOR SUSPENSION · INTRAVENOUS

Approval history

2021-04-09Labeling · Supplement 9 · standard — Label ↗AP
2020-12-02Labeling · Supplement 7 · standard — Letter ↗AP
2019-11-13Efficacy · Supplement 5 · standard — Label ↗AP
2016-12-22Efficacy · Supplement 2 · priority — Label ↗AP
2016-03-31Efficacy · Supplement 1 · standard — Label ↗AP
2014-10-10Type 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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