Estradiol Valerate and Estradiol Valerate/Dienogest

Sandoz Inc🇺🇸 United States

FDA Page

Effective Date: Jan 21, 2020
Approval ID: 0c3ac139-af85-4c70-ad3d-981e57d86f02
Products: 1 registered
Version: 4

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST TABLETS safely and effectively. See full prescribing information for Estradiol Valerate and Estradiol Valerate/Dienogest.ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGESTTABLETS, for oral useInitial U.S. Approval: 2010

Quick Stats

Total Products1

Labelers2

Label Sections18

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.