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FDA ANDA · ANDA091599

EPIRUBICIN HYDROCHLORIDE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA091599
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-12
LATEST ACTION
2015-12-23
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

2015-12-23Labeling · Supplement 3 · standardAP
2014-05-07Labeling · Supplement 1 · standardAP
2012-03-12OriginalAP
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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