RecallHawk

Summary

FDA approved OMNISCAN by GE HEALTHCARE. NDA (New Drug) approval (Labeling) on 2025-03-05. INJECTABLE, INJECTION.

Details

Source

Drug Approval

External ID

NDA022066-15

Action Date

2025-03-05

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

OMNISCAN, INJECTABLE, INJECTION. Application: NDA022066

Context & Analysis

GE HEALTHCARE has 32 FDA actions in our database, including 18 recalls and 9 clearances.

Frequently Asked Questions

How often does GE HEALTHCARE have FDA actions?

GE HEALTHCARE has 32 FDA actions in our database, including 18 recalls and 9 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA022066-15" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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