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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065331
Company: IMPAX LABS INC

Products on ANDA 065331

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065331

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/09/2007	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/10/2023	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
12/03/2014	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
12/03/2014	SUPPL-17	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065331

EPIRUBICIN HYDROCHLORIDE

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

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

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