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FDA NDA · NDA209607

AZEDRA

Sponsor: PROGENICS PHARMS INC

APPLICATION
NDA209607
TYPE
NDA
ORIGINAL APPROVAL
2018-07-30
LATEST ACTION
2023-02-14
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

AZEDRA · ReferenceDiscontinued
IOBENGUANE I-131 15mCi/ML · SOLUTION · INTRAVENOUS

Approval history

2023-02-14Labeling · Supplement 2 · standardLetterAP
2019-07-24Manufacturing (CMC) · Supplement 1AP
2018-07-30Type 5 - New Formulation or New Manufacturer · Original · priorityLabelAP
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