Application 216016

Type
NDA
Sponsor
BRACCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IOMERVUIOMEPROLSOLUTION;INTRA-ARTERIAL25GM IODINE/100ML (250MG IODINE/ML)YesNo
002IOMERVUIOMEPROLSOLUTION;INTRA-ARTERIAL15GM IODINE/50ML (300MG IODINE/ML)YesNo
003IOMERVUIOMEPROLSOLUTION;INTRA-ARTERIAL30GM IODINE/100ML (300MG IODINE/ML)YesNo
004IOMERVUIOMEPROLSOLUTION;INTRA-ARTERIAL45GM IODINE/150ML (300MG IODINE/ML)YesNo
005IOMERVUIOMEPROLSOLUTION;INTRA-ARTERIAL60GM IODINE/200ML (300MG IODINE/ML)YesNo
006IOMERVUIOMEPROLSOLUTION;INTRA-ARTERIAL17.5GM IODINE/50ML (350MG IODINE/ML)YesNo
007IOMERVUIOMEPROLSOLUTION;INTRA-ARTERIAL35GM IODINE/100ML (350MG IODINE/ML)YesYes
008IOMERVUIOMEPROLSOLUTION;INTRA-ARTERIAL52.5GM IODINE/150ML (350MG IODINE/MLYesNo
009IOMERVUIOMEPROLSOLUTION;INTRA-ARTERIAL70GM IODINE/200ML (350MG IODINE/ML)YesYes
010IOMERVUIOMEPROLSOLUTION;INTRA-ARTERIAL20GM IODINE/50ML (400MG IODINE/ML)YesNo
011IOMERVUIOMEPROLSOLUTION;INTRA-ARTERIAL40GM IODINE/100ML (400MG IODINE/ML)YesYes
012IOMERVUIOMEPROLSOLUTION;INTRA-ARTERIAL60GM IODINE/150ML (400MG IODINE/ML)YesNo
013IOMERVUIOMEPROLSOLUTION;INTRA-ARTERIAL80GM IODINE/200ML (400MG IODINE/ML)YesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80739ORIG 2024-12-26
80449ORIG 2024-11-29
80810ORIG 2024-11-27