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Generated: December 12, 2017

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:1
Applicant:1
Ingredient:1
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 0270-7099-16 5 KIT in 1 BOX (0270-7099-16) > 1 KIT in 1 KIT * 5 mL in 1 SYRINGE * 25 mg in 1 VIAL

Summary 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:► SubscribePatent Expiration:Nov 11, 2019Product Flag?YSubstance Flag?YDelist Request?


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