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FDA ANDA · ANDA200144

IDARUBICIN HYDROCHLORIDE

Sponsor: RISING

APPLICATION
ANDA200144
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-11
LATEST ACTION
2012-10-11
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

IDARUBICIN HYDROCHLORIDEDiscontinued
IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) · SOLUTION · INTRAVENOUS
IDARUBICIN HYDROCHLORIDEDiscontinued
IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) · SOLUTION · INTRAVENOUS
IDARUBICIN HYDROCHLORIDEDiscontinued
IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2012-10-11Not Applicable · OriginalAP
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