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US Department of Justice
Fish and Richardson
Moodys
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Cerilliant
US Army
QuintilesIMS
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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203684

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NDA 203684 describes LUMASON, which is a drug marketed by Bracco and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the LUMASON profile page.

The generic ingredient in LUMASON is sulfur hexafluoride lipid-type a microspheres. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sulfur hexafluoride lipid-type a microspheres profile page.
Summary for 203684
Tradename:LUMASON
Applicant:Bracco
Ingredient:sulfur hexafluoride lipid-type a microspheres
Patents:1
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 203684
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUMASON sulfur hexafluoride lipid-type a microspheres FOR SUSPENSION;INTRAVENOUS 203684 NDA BRACCO DIAGNOSTICS INC 0270-7099 N 0270-7099-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;INTRAVENOUSStrength60.7MG/25MG
Approval Date:Oct 15, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 31, 2019
Regulatory Exclusivity Use:EXPANDED INDICATION FOR USE IN ULTRASONOGRAPHY OF THE LIVER FOR CHARACTERIZATION OF FOCAL LIVER LESIONS IN ADULT AND PEDIATRIC PATIENTS
Regulatory Exclusivity Expiration:Oct 10, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Nov 11, 2019Product Flag?YSubstance Flag?YDelist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
Johnson and Johnson
QuintilesIMS
Baxter
Cantor Fitzgerald
Dow
US Department of Justice
Federal Trade Commission

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