QELBREE

Supernus Pharmaceuticals, Inc🇺🇸 United States

FDA Page

Effective Date: Dec 20, 2023
Approval ID: aedf408d-0f84-418d-9416-7c39ddb0d29a
Products: 3 registered
Version: 8

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use QELBREE safely and effectively. See full prescribing information for QELBREE . QELBREE (viloxazine extended-release capsules), for oral use Initial U.S. Approval: 2021

Quick Stats

Total Products3

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.