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Details for New Drug Application (NDA): 204677

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NDA 204677 describes NEURACEQ, which is a drug marketed by Piramal Imaging 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 NEURACEQ profile page.

The generic ingredient in NEURACEQ is florbetaben f-18. One supplier is listed for this compound. Additional details are available on the florbetaben f-18 profile page.

Summary for NDA: 204677

Tradename:
NEURACEQ
Applicant:
Piramal Imaging
Ingredient:
florbetaben f-18
Patents:1

Pharmacology for NDA: 204677

Mechanism of ActionPositron Emitting Activity

Suppliers and Packaging for NDA: 204677

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEURACEQ
florbetaben f-18
SOLUTION;INTRAVENOUS 204677 NDA Piramal Imaging, SA 54828-001 54828-001-30 1 VIAL, MULTI-DOSE in 1 CONTAINER (54828-001-30) > 30 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength30ML (1.4-135mCi/ML)
Approval Date:Mar 19, 2014TE:RLD:Yes
Patent:7,807,135Patent Expiration:Mar 18, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:NEURACEQ IS A RADIOACTIVE DIAGNOSTIC AGENT FOR POSITRON EMISSION TOMOGRAPHY (PET) IMAGING OF THE BRAIN TO ESTIMATE P-AMYLOID NEURITIC PLAQUE DENSITY IN ADULT PATIENTS WITH COGNITIVE IMPAIRMENT
Regulatory Exclusivity Expiration:Mar 21, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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