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AXUMIN

NDA · New Drug Application · Sponsor: BLUE EARTH · Approved 2016-05-27

Drug application

FDA Application #

NDA208054

Application type

New Drug Application

Brand name

AXUMIN

Generic name

FLUCICLOVINE F-18

Active ingredients

FLUCICLOVINE F-18

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

BLUE EARTH

Manufacturer

Blue Earth Diagnostics

First approval

2016-05-27

Source

Authoritative

Drugs@FDA application overview

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