Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065408
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 10MG/5ML (2MG/ML) INJECTABLE;INJECTION Prescription None No No
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE;INJECTION Prescription AP No No
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 150MG/75ML (2MG/ML) INJECTABLE;INJECTION Prescription None 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
10/15/2007 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 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 065411 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English