Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050807
Company: HOSPIRA

• Summary Review

Products on NDA 050807

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPIRUBICIN HYDROCHLORIDE	EPIRUBICIN HYDROCHLORIDE	50MG/VIAL	POWDER;INTRAVENOUS	Discontinued	None	No	No
EPIRUBICIN HYDROCHLORIDE	EPIRUBICIN HYDROCHLORIDE	200MG/VIAL	POWDER;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050807

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/2006	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050807lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050807ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050807s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050807s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/20/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 050807

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050807lbl.pdf