Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 216016
Company: BRACCO
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 |