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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050778
Company: PFIZER INC

Products on NDA 050778

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELLENCE	EPIRUBICIN HYDROCHLORIDE	200MG/100ML (2MG/ML)	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
ELLENCE	EPIRUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE;INJECTION	Prescription	AP	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050778

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/1999	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50778lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50778ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-778_Ellence.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/18/2021	SUPPL-26	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050778Orig1s026ltr.pdf
07/26/2019	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050778s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050778Orig1s024, 050778Orig1s025ltr.pdf
07/26/2019	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050778s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050778Orig1s024, 050778Orig1s025ltr.pdf
12/15/2014	SUPPL-21	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050778s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050778Orig1s021ltr.pdf
02/19/2013	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050778s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050778Orig1s019ltr.pdf
09/14/2011	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050778s015,s017,s018ltr.pdf
09/14/2011	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050778s015,s017,s018ltr.pdf
09/14/2011	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050778s015,s017,s018ltr.pdf
03/02/2005	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/50778s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50778s008ltr.pdf
04/03/2003	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50778slr004ltr.pdf
04/03/2003	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50778slr004ltr.pdf
07/20/2000	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 050778

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2019	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050778s024s025lbl.pdf
07/26/2019	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050778s024s025lbl.pdf
12/15/2014	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050778s021lbl.pdf
12/15/2014	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050778s021lbl.pdf
02/19/2013	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050778s019lbl.pdf
09/14/2011	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf
09/14/2011	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf
09/14/2011	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf
03/02/2005	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/50778s008lbl.pdf
09/15/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50778lbl.pdf

Therapeutic Equivalents for NDA 050778

ELLENCE

INJECTABLE;INJECTION; 200MG/100ML (2MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ELLENCE	EPIRUBICIN HYDROCHLORIDE	200MG/100ML (2MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	050778	PFIZER INC
EPIRUBICIN HYDROCHLORIDE	EPIRUBICIN HYDROCHLORIDE	200MG/100ML (2MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	065361	CIPLA LTD
EPIRUBICIN HYDROCHLORIDE	EPIRUBICIN HYDROCHLORIDE	200MG/100ML (2MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	065289	HIKMA
EPIRUBICIN HYDROCHLORIDE	EPIRUBICIN HYDROCHLORIDE	200MG/100ML (2MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090075	HISUN PHARM HANGZHOU
EPIRUBICIN HYDROCHLORIDE	EPIRUBICIN HYDROCHLORIDE	200MG/100ML (2MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	065331	IMPAX LABS INC

INJECTABLE;INJECTION; 50MG/25ML (2MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ELLENCE	EPIRUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	050778	PFIZER INC
EPIRUBICIN HYDROCHLORIDE	EPIRUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	065361	CIPLA LTD
EPIRUBICIN HYDROCHLORIDE	EPIRUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090163	EPIC PHARMA LLC
EPIRUBICIN HYDROCHLORIDE	EPIRUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	065289	HIKMA
EPIRUBICIN HYDROCHLORIDE	EPIRUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090075	HISUN PHARM HANGZHOU
EPIRUBICIN HYDROCHLORIDE	EPIRUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	065331	IMPAX LABS INC

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