Details for New Drug Application (NDA): 204677
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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 204677
Tradename: | NEURACEQ |
Applicant: | Life Molecular |
Ingredient: | florbetaben f-18 |
Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 204677
Generic Entry Date for 204677*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 204677
Mechanism of Action | Positron 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 | Life Molecular Imaging, Ltd | 54828-001 | 54828-001-50 | 1 VIAL, MULTI-DOSE in 1 CONTAINER (54828-001-50) / 50 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1.4-135mCi/ML | ||||
Approval Date: | Mar 19, 2014 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 18, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist 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 |
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