Application Nr Approved Date Route Status External Links
NDA021425 None Intra-Arterial None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ultravist ® Injection Is An Iodinated Contrast Agent Indicated For: Ultravist (Iopromide) Injection Is A Radiographic Contrast Agent Indicated For: • Cerebral Arteriography And Peripheral Arteriography (300 Mg Iodine Per Ml) ( 1.1 ) • Coronary Arteriography And Left Ventriculography, Visceral Angiography And Aortography (370 Mg Iodine Per Ml) ( 1.1 ) • Excretory Urography (300 Mg Iodine Per Ml) ( 1.2 ) • Contrast Computed Tomography (Ct) Imaging Of Head And Body (300 Mg Iodine Per Ml And 370 Mg Iodine Per Ml) ( 1.2 ) 1.1 Intra-Arterial Procedures* • 300 Mg Iodine Per Ml For Cerebral Arteriography And Peripheral Arteriography • 370 Mg Iodine Per Ml For Coronary Arteriography And Left Ventriculography, Visceral Angiography, And Aortography 1.2 Intravenous Procedures* • 300 Mg Iodine Per Ml For Excretory Urography • 300 Mg Iodine Per Ml And 370 Mg Iodine Per Ml For Contrast Computed Tomography (Ct) Of The Head And Body (Intrathoracic, Intra-Abdominal And Retroperitoneal Regions) For The Evaluation Of Neoplastic And Non-Neoplastic Lesions. The Usefulness Of Contrast Enhancement For The Investigation Of The Retrobulbar Space And Of Low Grade Or Infiltrative Glioma Has Not Been Demonstrated. *for Information On The Concentrations And Doses For The Pediatric Population [See Dosage And Administration ( 2.3 ) And Use In Specific Populations ( 8.4 )].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Iopromide IOPROMIDE ZINC3830959

Comments