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Details for New Drug Application (NDA): 021064

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NDA 021064 describes DEFINITY, which is a drug marketed by Lantheus Medcl and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the DEFINITY profile page.

The generic ingredient in DEFINITY is perflutren. One supplier is listed for this compound. Additional details are available on the perflutren profile page.

Summary for NDA: 021064

Tradename:
DEFINITY
Applicant:
Lantheus Medcl
Ingredient:
perflutren
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 021064

Mechanism of ActionUltrasound Contrast Activity

Suppliers and Packaging for NDA: 021064

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEFINITY
perflutren
INJECTABLE;INTRAVENOUS 021064 NDA Lantheus Medical Imaging, Inc. 11994-011 11994-011-01 1 VIAL, GLASS in 1 CARTON (11994-011-01) > 1.5 mL in 1 VIAL, GLASS
DEFINITY
perflutren
INJECTABLE;INTRAVENOUS 021064 NDA Lantheus Medical Imaging, Inc. 11994-011 11994-011-04 4 VIAL, GLASS in 1 CARTON (11994-011-04) > 1.5 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength6.52MG/ML
Approval Date:Jul 31, 2001TE:RLD:Yes
Patent:8,658,205Patent Expiration:Jun 18, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:6,033,645Patent Expiration:Jun 19, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
Patent:8,685,441Patent Expiration:Jan 13, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING

Expired Orange Book Patents for NDA: 021064

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lantheus Medcl
DEFINITY
perflutren
INJECTABLE;INTRAVENOUS021064-001Jul 31, 20015,527,521► subscribe
Lantheus Medcl
DEFINITY
perflutren
INJECTABLE;INTRAVENOUS021064-001Jul 31, 20016,033,645► subscribe
Lantheus Medcl
DEFINITY
perflutren
INJECTABLE;INTRAVENOUS021064-001Jul 31, 20016,528,039► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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