APPLICATION
ANDA214271
TYPE
ANDA
ORIGINAL APPROVAL
2022-05-19
LATEST ACTION
2025-06-27
ROUTE
INTRAVASCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
IODIXANOLPrescription
IODIXANOL 65.2% · INJECTABLE · INJECTION
IODIXANOLPrescription
IODIXANOL 55% · INJECTABLE · INJECTION
Approval history
2025-06-27Manufacturing (CMC) · Supplement 15 · unknownAP
2024-12-19Labeling · Supplement 8 · 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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