VyLibra

Afaxys Pharma, LLC🇺🇸 United States

FDA Page

Effective Date: Apr 13, 2023
Approval ID: 13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc3
Products: 1 registered
Version: 7

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use VyLibra safely and effectively. See full prescribing information for VyLibra. VyLibra (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989

Quick Stats

Total Products1

Labelers2

Label Sections20

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.