Adalimumab-adbm

Boehringer Ingelheim Pharmaceuticals, Inc.🇺🇸 United States

FDA Page

Effective Date: Aug 15, 2025
Approval ID: 62f39a7c-00df-4519-a8d4-39bbd0a649ed
Products: 6 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 ADALIMUMAB-ADBM safely and effectively. See full prescribing information for ADALIMUMAB-ADBM. ADALIMUMAB-ADBM injection, for subcutaneous use Initial U.S. Approval: 2017 This product is CYLTEZO (adalimumab-adbm). CYLTEZO (adalimumab-adbm) is biosimilar to HUMIRA (adalimumab).

Quick Stats

Total Products6

Labelers2

Label Sections54

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.