FDA Orange Book · active-ingredient family
Epirubicin hydrochloride
Epirubicin hydrochloride: 2 brands, 13 generics; first approved Sep 15, 1999; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
13
Listed patents
0
Presentations
34
Brand (NDA) products
Originator applications
- PFIZER INCNDA 05077819992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Rx AP 50MG/25ML (2MG/ML) INJECTABLE INJECTION Rx AP - EPIRUBICIN HYDROCHLORIDEHOSPIRANDA 05080720062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL POWDER INTRAVENOUS Discontinued — 200MG/VIAL POWDER INTRAVENOUS Discontinued —
Generic (ANDA) products (13)
Abbreviated applications
- EPIRUBICIN HYDROCHLORIDEPHARMOBEDIENTANDA 09159920122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/25ML (2MG/ML) INJECTABLE INJECTION Discontinued — 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued — - EPIRUBICIN HYDROCHLORIDEPHARMOBEDIENTANDA 09026620112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/25ML (2MG/ML) INJECTABLE INJECTION Discontinued — 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued — - EPIRUBICIN HYDROCHLORIDEHISUN PHARM HANGZHOUANDA 09007520102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/25ML (2MG/ML) INJECTABLE INJECTION Discontinued — 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued — - EPIRUBICIN HYDROCHLORIDEEBEWE PHARMAANDA 06533920092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/25ML (2MG/ML) INJECTABLE INJECTION Discontinued — 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued — - EPIRUBICIN HYDROCHLORIDEEPIC PHARMA LLCANDA 0901632009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/25ML (2MG/ML) INJECTABLE INJECTION Rx AP - EPIRUBICIN HYDROCHLORIDEACTAVIS TOTOWAANDA 06544520083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML (2MG/ML) INJECTABLE INJECTION Discontinued — 50MG/25ML (2MG/ML) INJECTABLE INJECTION Discontinued — 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued — - EPIRUBICIN HYDROCHLORIDEPHARMOBEDIENTANDA 06537120072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/25ML (2MG/ML) INJECTABLE INJECTION Discontinued — 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued — - EPIRUBICIN HYDROCHLORIDECIPLA LTDANDA 06536120072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/25ML (2MG/ML) INJECTABLE INJECTION Rx AP 200MG/100ML (2MG/ML) INJECTABLE INJECTION Rx AP - EPIRUBICIN HYDROCHLORIDEFRESENIUS KABI USAANDA 06540820074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML (2MG/ML) INJECTABLE INJECTION Discontinued — 50MG/25ML (2MG/ML) INJECTABLE INJECTION Discontinued — 150MG/75ML (2MG/ML) INJECTABLE INJECTION Discontinued — 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued — - EPIRUBICIN HYDROCHLORIDEFRESENIUS KABI USAANDA 06541120072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued — 50MG/25ML (2MG/ML) INJECTABLE INJECTION Discontinued — - EPIRUBICIN HYDROCHLORIDEIMPAX LABS INCANDA 06533120072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/25ML (2MG/ML) INJECTABLE INJECTION Rx AP 200MG/100ML (2MG/ML) INJECTABLE INJECTION Rx AP - EPIRUBICIN HYDROCHLORIDEHIKMAANDA 06528920072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/25ML (2MG/ML) INJECTABLE INJECTION Rx AP 200MG/100ML (2MG/ML) INJECTABLE INJECTION Rx AP - EPIRUBICIN HYDROCHLORIDEHOSPIRAANDA 06534320074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML (2MG/ML) INJECTABLE INJECTION Discontinued — 50MG/25ML (2MG/ML) INJECTABLE INJECTION Discontinued — 150MG/75ML (2MG/ML) INJECTABLE INJECTION Discontinued — 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
27 yr 4 mo ago
Most recent approval
14 yr 8 mo ago
Approvals span 1999–2012 across 15 FDA applications.
Brand (NDA) 213%
Generic (ANDA) 1387%
Epirubicin hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
