APPLICATION
ANDA065445
TYPE
ANDA
ORIGINAL APPROVAL
2008-09-18
LATEST ACTION
2016-03-23
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
EPIRUBICIN HYDROCHLORIDEDiscontinued
EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) · INJECTABLE · INJECTION
Approval history
2016-03-23Labeling · Supplement 8 · standardAP
2014-12-19Labeling · Supplement 4AP
2014-12-19Labeling · Supplement 5 · standardAP
2010-05-24Labeling · Supplement 2AP
2008-09-18OriginalAP
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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