Safyral

Bayer HealthCare Pharmaceuticals Inc.🇺🇸 United States

FDA Page

Effective Date: Dec 19, 2025
Approval ID: 97563516-306a-4e17-9690-edbda49ecd83
Products: 1 registered
Version: 19

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use SAFYRAL safely and effectively. See full prescribing information for SAFYRAL.SAFYRAL (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) for oral use Initial U.S. Approval: 2010

Quick Stats

Total Products1

Labelers2

Label Sections29

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.