Orange Book product · Brand (NDA)
ELLENCE
EPIRUBICIN HYDROCHLORIDE
At a glance
Sep 15, 1999
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 15, 1999
27 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
EPIRUBICIN HYDROCHLORIDE
Strength
50MG/25ML (2MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 050778
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2006EPIRUBICIN HYDROCHLORIDEBrand (NDA)
NDA 050807 · HOSPIRA
- 2012EPIRUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 091599 · PHARMOBEDIENT
- 2011EPIRUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 090266 · PHARMOBEDIENT
- 2010EPIRUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 090075 · HISUN PHARM HANGZHOU
- 2009EPIRUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 065339 · EBEWE PHARMA
- 2009EPIRUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 090163 · EPIC PHARMA LLC
- 2008EPIRUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 065445 · ACTAVIS TOTOWA
- 2007EPIRUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 065371 · PHARMOBEDIENT
- 2007EPIRUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 065361 · CIPLA LTD
- 2007EPIRUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 065408 · FRESENIUS KABI USA
- 2007EPIRUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 065411 · FRESENIUS KABI USA
- 2007EPIRUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 065331 · IMPAX LABS INC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
