← FDA Drug Approvals (Drugs@FDA)

BENDAMUSTINE HYDROCHLORIDE

NDA · New Drug Application · Sponsor: AVYXA HOLDINGS · Approved 2025-07-03

Drug application

FDA Application #

NDA219014

Application type

New Drug Application

Brand name

BENDAMUSTINE HYDROCHLORIDE

Generic name

Bendamustine Hydrochloride

Active ingredients

BENDAMUSTINE HYDROCHLORIDE

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

AVYXA HOLDINGS

First approval

2025-07-03

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown