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FDA ANDA · ANDA091293

IDARUBICIN HYDROCHLORIDE

Sponsor: SANDOZ

APPLICATION
ANDA091293
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-29
LATEST ACTION
2011-03-29
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

2011-03-29OriginalAP
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