APPLICATION
ANDA065331
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-09
LATEST ACTION
2023-01-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
EPIRUBICIN HYDROCHLORIDEPrescription
EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) · INJECTABLE · INJECTION
EPIRUBICIN HYDROCHLORIDEPrescription
EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) · INJECTABLE · INJECTION
Approval history
2023-01-10Labeling · Supplement 28 · standardAP
2014-12-03Labeling · Supplement 22 · standardAP
2014-12-03Labeling · Supplement 17AP
2007-08-09OriginalAP
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.