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FDA NDA · NDA208054

AXUMIN

fluciclovine f-18

Sponsor: BLUE EARTH

APPLICATION
NDA208054
TYPE
NDA
ORIGINAL APPROVAL
2016-05-27
LATEST ACTION
2021-05-21
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

AXUMIN · ReferencePrescription
FLUCICLOVINE F-18 9-221mCi/ML · SOLUTION · INTRAVENOUS

Approval history

2021-05-21Labeling · Supplement 34 · standard — Label ↗AP
2017-01-24Manufacturing (CMC) · Supplement 3 · standardAP
2016-12-19Manufacturing (CMC) · Supplement 2 · standardAP
2016-05-27Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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