Sertraline hydrochloride

Preferred Pharmaceuticals Inc.🇺🇸 United States

FDA Page

Effective Date: Aug 28, 2026
Approval ID: 4da914d0-629e-4766-b57f-6119fa8283cf
Products: 1 registered
Version: 3

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

Sertraline Hydrochloride tablets 25 mg, 50 mg, and 100 mg Tablets These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval:1991

Quick Stats

Total Products1

Labelers1

Label Sections40

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.