SERTRALINE HYDROCHLORIDE

Aphena Pharma Solutions - Tennessee, LLC🇺🇸 United States

FDA Page

Effective Date: Jun 19, 2020
Approval ID: ccb264a4-5d50-4317-a67e-ba6daa2b8297
Products: 1 registered
Version: 1

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE. Sertraline hydrochloride tablets, for oral use Sertraline hydrochloride oral solution Initial U.S. Approval: 1991

Quick Stats

Total Products1

Labelers2

Label Sections22

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.