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FDA NDA · NDA203155

CHOLINE C 11

choline c-11

Sponsor: MCPRF

APPLICATION
NDA203155
TYPE
NDA
ORIGINAL APPROVAL
2012-09-12
LATEST ACTION
2024-09-09
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CHOLINE C-11 · ReferencePrescription
CHOLINE C-11 4-33.1mCi/ML · INJECTABLE · INTRAVENOUS

Approval history

2024-09-09Labeling · Supplement 9 · standard — Label ↗AP
2015-10-28Manufacturing (CMC) · Supplement 5 · priorityAP
2015-03-30Manufacturing (CMC) · Supplement 4 · priorityAP
2014-11-16Manufacturing (CMC) · Supplement 33 · priorityAP
2013-10-30Manufacturing (CMC) · Supplement 2 · priorityAP
2013-07-26Manufacturing (CMC) · Supplement 1 · priorityAP
2012-09-12Type 1 - New Molecular Entity · Original · priority — Review ↗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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