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FDA Orange Book · active-ingredient family

Epirubicin hydrochloride

Epirubicin hydrochloride is approved as 2 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ELLENCE · NDA 050778

2

Brand (NDA)

13

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, powder

ProductApplicantApplicationTEApproved
ELLENCERLD×2PFIZER INCNDA 050778APSep 15, 1999
EPIRUBICIN HYDROCHLORIDE×2HOSPIRANDA 050807—Sep 15, 2006

Generic (ANDA) products (13)

ProductApplicantApplicationTEApproved
EPIRUBICIN HYDROCHLORIDE×2PHARMOBEDIENTANDA 091599—Mar 12, 2012
EPIRUBICIN HYDROCHLORIDE×2PHARMOBEDIENTANDA 090266—Apr 15, 2011
EPIRUBICIN HYDROCHLORIDE×2HISUN PHARM HANGZHOUANDA 090075—Mar 25, 2010
EPIRUBICIN HYDROCHLORIDE×2EBEWE PHARMAANDA 065339—Dec 22, 2009
EPIRUBICIN HYDROCHLORIDEEPIC PHARMA LLCANDA 090163APJun 24, 2009
EPIRUBICIN HYDROCHLORIDE×3ACTAVIS TOTOWAANDA 065445—Sep 18, 2008
EPIRUBICIN HYDROCHLORIDE×2PHARMOBEDIENTANDA 065371—Nov 28, 2007
EPIRUBICIN HYDROCHLORIDE×2CIPLA LTDANDA 065361APOct 22, 2007
EPIRUBICIN HYDROCHLORIDE×4FRESENIUS KABI USAANDA 065408—Oct 15, 2007
EPIRUBICIN HYDROCHLORIDE×2FRESENIUS KABI USAANDA 065411—Aug 20, 2007
EPIRUBICIN HYDROCHLORIDE×2IMPAX LABS INCANDA 065331APAug 09, 2007
EPIRUBICIN HYDROCHLORIDE×2HIKMAANDA 065289APJun 27, 2007
EPIRUBICIN HYDROCHLORIDE×4HOSPIRAANDA 065343—Apr 19, 2007

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.

Epirubicin hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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