← FDA DRUG APPROVALS

FDA ANDA · ANDA209814

BENDAMUSTINE HYDROCHLORIDE

Sponsor: CELERITY PHARMS

APPLICATION
ANDA209814
TYPE
ANDA
ROUTE
IV (INFUSION)
DOSAGE FORM
POWDER
MARKETING STATUS
None (Tentative Approval)

Products

BENDAMUSTINE HYDROCHLORIDENone (Tentative Approval)
BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL · POWDER · IV (INFUSION)
BENDAMUSTINE HYDROCHLORIDENone (Tentative Approval)
BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL · POWDER · IV (INFUSION)

Approval history

2019-01-25UNKNOWN · Original · standardLetterTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →