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FDA NDA · NDA200655

FLUORODOPA F18

Sponsor: FEINSTEIN

APPLICATION
NDA200655
TYPE
NDA
ORIGINAL APPROVAL
2019-10-10
LATEST ACTION
2020-12-11
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

FLUORODOPA F18 · ReferencePrescription
FLUORODOPA F-18 1-40mCi/ML · SOLUTION · INTRAVENOUS
FLUORODOPA F18 · ReferencePrescription
FLUORODOPA F-18 1-40mCi/ML · SOLUTION · INTRAVENOUS

Approval history

2020-12-11Manufacturing (CMC) · Supplement 1 — Label ↗AP
2019-10-10Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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