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Last Updated: October 15, 2019

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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 two suppliers. There are three patents 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. Two suppliers are 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:3
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 * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE
LUMASON sulfur hexafluoride lipid-type a microspheres FOR SUSPENSION;INTRAVENOUS 203684 NDA Bracco Suisse SA 68155-099 68155-099-16 5 KIT in 1 BOX (68155-099-16) > 1 KIT in 1 KIT * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE

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:  See PricingPatent Expiration:Jul 6, 2038Product Flag?YSubstance Flag?Delist Request?

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