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FDA ANDA · ANDA065289

EPIRUBICIN HYDROCHLORIDE

Sponsor: HIKMA

APPLICATION
ANDA065289
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-27
LATEST ACTION
2017-07-19
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

2017-07-19Manufacturing (CMC) · Supplement 5 · unknownAP
2013-01-09Labeling · Supplement 3 · standardAP
2007-06-27OriginalAP
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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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