← FDA DRUG APPROVALS

FDA ANDA · ANDA211001

BENDAMUSTINE

bendamustine hcl

Sponsor: MEITHEAL

APPLICATION
ANDA211001
TYPE
ANDA
ORIGINAL APPROVAL
2023-06-05
LATEST ACTION
2023-06-05
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

BENDAMUSTINE HYDROCHLORIDEPrescription
BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL · POWDER · INTRAVENOUS
BENDAMUSTINE HYDROCHLORIDEPrescription
BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL · POWDER · INTRAVENOUS

Approval history

2023-06-05UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →