Dyanavel XR

NextWave Pharmaceuticals, Inc🇺🇸 United States

FDA Page

Effective Date: Oct 26, 2023
Approval ID: ae304b29-0b40-40ec-ad0d-76b742d4a9b9
Products: 5 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 DYANAVEL XR safely and effectively. See full prescribing information for DYANAVEL XR . DYANAVEL XR (amphetamine) extended-release oral suspension , CII DYANAVEL XR (amphetamine) extended-release tablets, for oral use, CII Initial U.S. Approval: 1 960

Quick Stats

Total Products5

Labelers2

Label Sections25

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.