Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065445
Company: ACTAVIS TOTOWA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE;INJECTION Discontinued None No No
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/18/2008 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
03/23/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/19/2014 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/19/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

05/24/2010 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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 065445 ACTAVIS TOTOWA
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 090163 AKORN 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 065408 FRESENIUS KABI USA
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
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 065289 WEST-WARD PHARMS INT

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 065445 ACTAVIS TOTOWA
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 065408 FRESENIUS KABI USA
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
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 065289 WEST-WARD PHARMS INT

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