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 are two 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. 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:	2
Formulation / Manufacturing:	see details

Pharmacology for NDA: 203684

Mechanism of Action	Ultrasound Contrast Activity

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	0270-7097	0270-7097-08	20 VIAL in 1 BOX (0270-7097-08) / 25 mg in 1 VIAL
LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684	NDA	BRACCO DIAGNOSTICS INC	0270-7097	0270-7097-07	20 VIAL in 1 BOX (0270-7097-07) / 25 mg in 1 VIAL

Profile 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:	Nov 13, 2022
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Patent:	⤷ Try a Trial	Patent Expiration:	Jul 6, 2038	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	Jul 6, 2038	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 203684

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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