U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 216016
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IOMERVU IOMEPROL 25GM IODINE/100ML (250MG IODINE/ML) SOLUTION;INTRA-ARTERIAL Prescription None Yes Yes
IOMERVU IOMEPROL 15GM IODINE/50ML (300MG IODINE/ML) SOLUTION;INTRA-ARTERIAL Prescription None Yes Yes
IOMERVU IOMEPROL 30GM IODINE/100ML (300MG IODINE/ML) SOLUTION;INTRA-ARTERIAL Prescription None Yes Yes
IOMERVU IOMEPROL 45GM IODINE/150ML (300MG IODINE/ML) SOLUTION;INTRA-ARTERIAL Prescription None Yes Yes
IOMERVU IOMEPROL 60GM IODINE/200ML (300MG IODINE/ML) SOLUTION;INTRA-ARTERIAL Prescription None Yes Yes
IOMERVU IOMEPROL 17.5GM IODINE/50ML (350MG IODINE/ML) SOLUTION;INTRA-ARTERIAL Prescription None Yes Yes
IOMERVU IOMEPROL 35GM IODINE/100ML (350MG IODINE/ML) SOLUTION;INTRA-ARTERIAL Prescription None Yes Yes
IOMERVU IOMEPROL 52.5GM IODINE/150ML (350MG IODINE/ML SOLUTION;INTRA-ARTERIAL Prescription None Yes Yes
IOMERVU IOMEPROL 70GM IODINE/200ML (350MG IODINE/ML) SOLUTION;INTRA-ARTERIAL Prescription None Yes Yes
IOMERVU IOMEPROL 20GM IODINE/50ML (400MG IODINE/ML) SOLUTION;INTRA-ARTERIAL Prescription None Yes Yes
IOMERVU IOMEPROL 40GM IODINE/100ML (400MG IODINE/ML) SOLUTION;INTRA-ARTERIAL Prescription None Yes Yes
IOMERVU IOMEPROL 60GM IODINE/150ML (400MG IODINE/ML) SOLUTION;INTRA-ARTERIAL Prescription None Yes Yes
IOMERVU IOMEPROL 80GM IODINE/200ML (400MG IODINE/ML) SOLUTION;INTRA-ARTERIAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/27/2024 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216017s000,216017s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216016Orig1s000;216017Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216016Orig1s000,216017Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/27/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216017s000,216017s000lbl.pdf
Back to Top