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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

Blue Earth
fluciclovine f-18

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, 2016Product 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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