APPLICATION
ANDA206554
TYPE
ANDA
ORIGINAL APPROVAL
2023-06-07
LATEST ACTION
2023-06-07
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued
Products
BENDAMUSTINE HYDROCHLORIDEDiscontinued
BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL · POWDER · INTRAVENOUS
BENDAMUSTINE HYDROCHLORIDEDiscontinued
BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL · POWDER · INTRAVENOUS
Approval history
2023-06-07UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.