Application 216017

Type
NDA
Sponsor
BRACCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IOMERVUIOMEPROLSOLUTION;INTRAVENOUS25GM IODINE/100ML (250MG IODINE/ML)YesNo
002IOMERVUIOMEPROLSOLUTION;INTRAVENOUS15GM IODINE/50ML (300MG IODINE/ML)YesNo
003IOMERVUIOMEPROLSOLUTION;INTRAVENOUS30GM IODINE/100ML (300MG IODINE/ML)YesNo
004IOMERVUIOMEPROLSOLUTION;INTRAVENOUS45GM IODINE/150ML (300MG IODINE/ML)YesNo
005IOMERVUIOMEPROLSOLUTION;INTRAVENOUS60GM IODINE/200ML (300MG IODINE/ML)YesNo
006IOMERVUIOMEPROLSOLUTION;INTRAVENOUS17.5GM IODINE/50ML (350MG IODINE/ML)YesNo
007IOMERVUIOMEPROLSOLUTION;INTRAVENOUS35GM IODINE/100ML (350MG IODINE/ML)YesYes
008IOMERVUIOMEPROLSOLUTION;INTRAVENOUS52.5GM IODINE/150ML (350MG IODINE/ML)YesNo
009IOMERVUIOMEPROLSOLUTION;INTRAVENOUS70GM IODINE/200ML (350MG IODINE/ML)YesYes
010IOMERVUIOMEPROLSOLUTION;INTRAVENOUS20GM IODINE/50ML (400MG IODINE/ML)YesNo
011IOMERVUIOMEPROLSOLUTION;INTRAVENOUS40GM IODINE/100ML (400MG IODINE/ML)YesYes
012IOMERVUIOMEPROLSOLUTION;INTRAVENOUS60GM IODINE/150ML (400MG IODINE/ML)YesNo
013IOMERVUIOMEPROLSOLUTION;INTRAVENOUS80GM IODINE/200ML (400MG IODINE/ML)YesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80740ORIG 2024-12-26
80453ORIG 2024-11-29
80450ORIG 2024-11-29