REMERON

Organon LLC🇺🇸 United States

FDA Page

Effective Date: Mar 4, 2024
Approval ID: 98ad1917-a094-44f5-a28f-a64a8cfcd887
Products: 5 registered
Version: 5

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use REMERON/REMERONSolTab safely and effectively. See full prescribing information for REMERON/REMERONSolTab. REMERON (mirtazapine) tablets, for oral use REMERONSolTab (mirtazapine) orally disintegrating tablets Initial U.S. Approval: 1996

Quick Stats

Total Products5

Labelers2

Label Sections43

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.