Cotempla XR-ODT

Neos Therapeutics Brands, LLC🇺🇸 United States

FDA Page

Effective Date: Mar 27, 2024
Approval ID: 33f70f58-c871-42c8-8adb-345caeafefcd
Products: 3 registered
Version: 11

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use COTEMPLA XR-ODT safely and effectively. See full prescribing information for COTEMPLA XR-ODT. COTEMPLA XR-ODT (methylphenidate extended-release orally disintegrating tablets), CII Initial U.S. Approval: 1955

Quick Stats

Total Products3

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.