Dutasteride and tamsulosin hydrochloride

Zydus Pharmaceuticals USA Inc.🇺🇸 United States

FDA Page

Effective Date: Oct 6, 2022
Approval ID: d6557691-7910-4006-9268-410583e437d1
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 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES. DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE Capsules, for oral use Initial U.S. Approval: 2010

Quick Stats

Total Products1

Labelers2

Label Sections33

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.