RecallHawk

FERABRIGHT (FERUMOXYTOL)

AZURITY

Summary

FDA approved FERABRIGHT (FERUMOXYTOL) by AZURITY. NDA (New Drug) approval (Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated) on 2025-10-16. SOLUTION, INTRAVENOUS.

Details

Source

Drug Approval

External ID

NDA219868-1

Action Date

2025-10-16

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

FERABRIGHT (generic: FERUMOXYTOL), SOLUTION, INTRAVENOUS. Application: NDA219868

Company

Context & Analysis

AZURITY has 21 FDA actions in our database.

Frequently Asked Questions

How often does AZURITY have FDA actions?

AZURITY has 21 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA219868-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for drug

Related Actions