Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090163
Company: AKORN INC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/24/2009 ORIG-1 Approval

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 065411 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 091599 MYLAN LABS LTD
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 065289 WEST-WARD PHARMS INT

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