FDA NDA · NDA220583

ISOVUE READI

Sponsor: BRACCO

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APPLICATION
NDA220583
TYPE
NDA
ORIGINAL APPROVAL
2026-10-09
LATEST ACTION
2026-10-09
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ISOVUE READIPrescription
IOPAMIDOL 300MG · SOLUTION · ORAL
ISOVUE READIPrescription
IOPAMIDOL 200MG · SOLUTION · ORAL
ISOVUE READIPrescription
IOPAMIDOL 370MG · SOLUTION · ORAL
ISOVUE READIPrescription
IOPAMIDOL 250MG · SOLUTION · ORAL

Approval history

2026-10-09Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP