APPLICATION
ANDA090163
TYPE
ANDA
ORIGINAL APPROVAL
2009-06-24
LATEST ACTION
2009-06-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
EPIRUBICIN HYDROCHLORIDEPrescription
EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) · INJECTABLE · INJECTION
Approval history
2009-06-24OriginalAP
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.