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Generated: April 27, 2017

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Details for New Drug Application (NDA): 208054

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NDA 208054 describes AXUMIN, which is a drug marketed by Blue Earth 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 AXUMIN profile page.

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

Summary for NDA: 208054


Pharmacology for NDA: 208054

Mechanism of ActionPositron Emitting Activity

Suppliers and Packaging for NDA: 208054

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
fluciclovine f-18
SOLUTION;INTRAVENOUS 208054 NDA Blue Earth Diagnostics 69932-001 69932-001-30 30 mL in 1 VIAL, MULTI-DOSE (69932-001-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength9-221mCi/ML
Approval Date:May 27, 2016TE:RLD:Yes
Patent:5,808,146Patent Expiration:Nov 9, 2017Product Flag?Substance Flag?YDelist Request?
Patent:9,387,266Patent Expiration:Nov 28, 2026Product Flag?Substance Flag?Delist Request?
Regulatory Exclusivity Expiration:May 27, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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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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