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FDA ANDA · ANDA065275

IDARUBICIN HYDROCHLORIDE

Sponsor: HIKMA

APPLICATION
ANDA065275
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-14
LATEST ACTION
2006-12-14
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

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

Approval history

2006-12-14OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

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