APPLICATION
ANDA065037
TYPE
ANDA
ORIGINAL APPROVAL
2002-05-01
LATEST ACTION
2002-05-01
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued
Products
IDARUBICIN HYDROCHLORIDEDiscontinued
IDARUBICIN HYDROCHLORIDE 5MG/VIAL · POWDER · INTRAVENOUS
IDARUBICIN HYDROCHLORIDEDiscontinued
IDARUBICIN HYDROCHLORIDE 20MG/VIAL · POWDER · INTRAVENOUS
IDARUBICIN HYDROCHLORIDEDiscontinued
IDARUBICIN HYDROCHLORIDE 10MG/VIAL · POWDER · INTRAVENOUS
Approval history
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.