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FDA ANDA · ANDA065411

EPIRUBICIN HYDROCHLORIDE

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA065411
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-20
LATEST ACTION
2009-05-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

EPIRUBICIN HYDROCHLORIDEDiscontinued
EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) · INJECTABLE · INJECTION
EPIRUBICIN HYDROCHLORIDEDiscontinued
EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) · INJECTABLE · INJECTION

Approval history

2009-05-22Labeling · Supplement 1AP
2007-08-20OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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