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Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202008

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NDA 202008 describes AMYVID, which is a drug marketed by Avid Radiopharms Inc 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 AMYVID profile page.

The generic ingredient in AMYVID is florbetapir f-18. One supplier is listed for this compound. Additional details are available on the florbetapir f-18 profile page.
Summary for 202008
Tradename:AMYVID
Applicant:Avid Radiopharms Inc
Ingredient:florbetapir f-18
Patents:2
Pharmacology for NDA: 202008
Mechanism of ActionPositron Emitting Activity
Suppliers and Packaging for NDA: 202008
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMYVID florbetapir f-18 SOLUTION;INTRAVENOUS 202008 NDA Eli Lilly and Company 0002-1200 N 0002-1200-50
AMYVID florbetapir f-18 SOLUTION;INTRAVENOUS 202008 NDA Eli Lilly and Company 0002-1200 N 0002-1200-30

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength10ML (13.5-51mCi/ML)
Approval Date:Apr 6, 2012TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Apr 30, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Apr 30, 2027Product Flag?YSubstance Flag?YDelist Request?
Patented Use:AMYVID IS A RADIOACTIVE DIAGNOSTIC AGENT FOR POSITRON EMISSION TOMOGRAPHY (PET) IMAGING OF THE BRAIN TO ESTIMATE BETA-AMYLOID NEURITIC PLAQUE DENSITY IN ADULT PATIENTS WITH COGNITIVE IMPAIRMENT

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10-30ML (13.5-51mCi/ML)
Approval Date:Apr 6, 2012TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Apr 30, 2027Product Flag?YSubstance Flag?YDelist Request?

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