Bendamustine Hydrochloride

Apotex Corp🇺🇸 United States

FDA Page

Effective Date: Sep 9, 2026
Approval ID: 085dd54c-4212-d879-afef-ee52732a48c0
Products: 1 registered
Version: 9

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE INJECTION. BENDAMUSTINE HYDROCHLORIDE injection, for intravenous useInitial U.S. Approval: 2008

Quick Stats

Total Products1

Labelers2

Label Sections35

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.