APPLICATION
ANDA206319
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-13
LATEST ACTION
2018-03-26
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CHOLINE C-11Prescription
CHOLINE C-11 4-33.1mCi/ML · INJECTABLE · INTRAVENOUS
Approval history
2018-03-26Manufacturing (CMC) · Supplement 5AP
2018-03-26Labeling · Supplement 1 · standardAP
2016-07-22Manufacturing (CMC) · Supplement 3 · unknownAP
2015-11-13UNKNOWN · Original · standardAP
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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