ALBUTEIN

GRIFOLS USA, LLC🇺🇸 United States

FDA Page

Effective Date: May 28, 2025
Approval ID: 9c45986e-4e62-4f7d-971c-bec74dc4d234
Products: 1 registered
Version: 17

Regulatory Information

Labeling Type

PLASMA DERIVATIVE

Status

Approved

Full Title

These highlights do not include all the information needed to use ALBUTEIN 5% safely and effectively. See full prescribing information for ALBUTEIN 5%. ALBUTEIN 5% (albumin [human] U.S.P.)5% solution Initial U.S. Approval: 1978

Quick Stats

Total Products1

Labelers1

Label Sections35

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.