RecallHawk

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

BAYER HLTHCARE

Summary

FDA approved AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER by BAYER HLTHCARE. NDA (New Drug) approval (Labeling) on 2025-07-11. SOLUTION, INTRAVENOUS.

Details

Source

Drug Approval

External ID

NDA021277-65

Action Date

2025-07-11

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, SOLUTION, INTRAVENOUS. Application: NDA021277

Context & Analysis

BAYER HLTHCARE has 11 FDA actions in our database.

Frequently Asked Questions

How often does BAYER HLTHCARE have FDA actions?

BAYER HLTHCARE has 11 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 "NDA021277-65" 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