Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216017

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IOMERVU (IOMEPROL)
15GM IODINE/50ML (300MG IODINE/ML)
Marketing Status: Discontinued

Active Ingredient: IOMEPROL
Proprietary Name: IOMERVU
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 15GM IODINE/50ML (300MG IODINE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216017
Product Number: 002
Approval Date: Nov 27, 2024
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

IOMERVU (IOMEPROL)
17.5GM IODINE/50ML (350MG IODINE/ML)
Marketing Status: Discontinued

Active Ingredient: IOMEPROL
Proprietary Name: IOMERVU
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 17.5GM IODINE/50ML (350MG IODINE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216017
Product Number: 006
Approval Date: Nov 27, 2024
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

IOMERVU (IOMEPROL)
20GM IODINE/50ML (400MG IODINE/ML)
Marketing Status: Discontinued

Active Ingredient: IOMEPROL
Proprietary Name: IOMERVU
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 20GM IODINE/50ML (400MG IODINE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216017
Product Number: 010
Approval Date: Nov 27, 2024
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

IOMERVU (IOMEPROL)
25GM IODINE/100ML (250MG IODINE/ML)
Marketing Status: Discontinued

Active Ingredient: IOMEPROL
Proprietary Name: IOMERVU
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 25GM IODINE/100ML (250MG IODINE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216017
Product Number: 001
Approval Date: Nov 27, 2024
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

IOMERVU (IOMEPROL)
30GM IODINE/100ML (300MG IODINE/ML)
Marketing Status: Discontinued

Active Ingredient: IOMEPROL
Proprietary Name: IOMERVU
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 30GM IODINE/100ML (300MG IODINE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216017
Product Number: 003
Approval Date: Nov 27, 2024
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

IOMERVU (IOMEPROL)
35GM IODINE/100ML (350MG IODINE/ML)
Marketing Status: Discontinued

Active Ingredient: IOMEPROL
Proprietary Name: IOMERVU
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 35GM IODINE/100ML (350MG IODINE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216017
Product Number: 007
Approval Date: Nov 27, 2024
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

IOMERVU (IOMEPROL)
40GM IODINE/100ML (400MG IODINE/ML)
Marketing Status: Discontinued

Active Ingredient: IOMEPROL
Proprietary Name: IOMERVU
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 40GM IODINE/100ML (400MG IODINE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216017
Product Number: 011
Approval Date: Nov 27, 2024
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

IOMERVU (IOMEPROL)
60GM IODINE/150ML (400MG IODINE/ML)
Marketing Status: Discontinued

Active Ingredient: IOMEPROL
Proprietary Name: IOMERVU
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 60GM IODINE/150ML (400MG IODINE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216017
Product Number: 012
Approval Date: Nov 27, 2024
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

IOMERVU (IOMEPROL)
45GM IODINE/150ML (300MG IODINE/ML)
Marketing Status: Discontinued

Active Ingredient: IOMEPROL
Proprietary Name: IOMERVU
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 45GM IODINE/150ML (300MG IODINE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216017
Product Number: 004
Approval Date: Nov 27, 2024
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

IOMERVU (IOMEPROL)
52.5GM IODINE/150ML (350MG IODINE/ML)
Marketing Status: Discontinued

Active Ingredient: IOMEPROL
Proprietary Name: IOMERVU
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 52.5GM IODINE/150ML (350MG IODINE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216017
Product Number: 008
Approval Date: Nov 27, 2024
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

IOMERVU (IOMEPROL)
60GM IODINE/200ML (300MG IODINE/ML)
Marketing Status: Discontinued

Active Ingredient: IOMEPROL
Proprietary Name: IOMERVU
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 60GM IODINE/200ML (300MG IODINE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216017
Product Number: 005
Approval Date: Nov 27, 2024
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

IOMERVU (IOMEPROL)
70GM IODINE/200ML (350MG IODINE/ML)
Marketing Status: Discontinued

Active Ingredient: IOMEPROL
Proprietary Name: IOMERVU
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 70GM IODINE/200ML (350MG IODINE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216017
Product Number: 009
Approval Date: Nov 27, 2024
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

IOMERVU (IOMEPROL)
80GM IODINE/200ML (400MG IODINE/ML)
Marketing Status: Discontinued

Active Ingredient: IOMEPROL
Proprietary Name: IOMERVU
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 80GM IODINE/200ML (400MG IODINE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216017
Product Number: 013
Approval Date: Nov 27, 2024
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information