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FDA ANDA · ANDA202586

INDIUM IN 111 OXYQUINOLINE

indium in-111 oxyquinoline

Sponsor: BWXT ITG

APPLICATION
ANDA202586
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-25
LATEST ACTION
2018-07-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

INDIUM IN 111 OXYQUINOLINEPrescription
INDIUM IN-111 OXYQUINOLINE 1mCi/ML · INJECTABLE · INJECTION

Approval history

2018-07-25UNKNOWN · OriginalLetterAP
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