Generated: December 12, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 203684
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, 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
|Formulation / Manufacturing:||see details|Complete Access Available with Subscription
Summary for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||FOR SUSPENSION;INTRAVENOUS||Strength||60.7MG/25MG|
|Approval Date:||Oct 15, 2014||TE:||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:||► Subscribe||Patent Expiration:||Nov 11, 2019||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
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