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FDA NDA · NDA050807

EPIRUBICIN HYDROCHLORIDE

Sponsor: HOSPIRA

APPLICATION
NDA050807
TYPE
NDA
ORIGINAL APPROVAL
2006-09-15
LATEST ACTION
2013-06-20
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

EPIRUBICIN HYDROCHLORIDEDiscontinued
EPIRUBICIN HYDROCHLORIDE 50MG/VIAL · POWDER · INTRAVENOUS
EPIRUBICIN HYDROCHLORIDEDiscontinued
EPIRUBICIN HYDROCHLORIDE 200MG/VIAL · POWDER · INTRAVENOUS

Approval history

2013-06-20Manufacturing (CMC) · Supplement 2 · standardAP
2006-09-15Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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