FDA Orange Book · active-ingredient family
Doxorubicin hydrochloride
Doxorubicin hydrochloride: 3 brands, 27 generics; first approved May 20, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 27 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
27
Listed patents
0
Presentations
56
Brand (NDA) products
Originator applications
- BAXTER HLTHCARE CORPNDA 05071819952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB - DOXORUBICIN HYDROCHLORIDERLDRSPFIZERNDA 05062919873 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP 200MG/100ML INJECTABLE INJECTION Rx AP 150MG/75ML INJECTABLE INJECTION Discontinued — - DOXORUBICIN HYDROCHLORIDEPFIZERNDA 050467—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/VIAL INJECTABLE INJECTION Discontinued — 50MG/VIAL INJECTABLE INJECTION Discontinued — 20MG/VIAL INJECTABLE INJECTION Discontinued — 150MG/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (27)
Abbreviated applications
- DOXORUBICIN HYDROCHLORIDEQILU PHARM HAINANANDA 21988120262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB - ALEMBICANDA 21919920252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB - LUPINANDA 21517820242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB - BAXTER HLTHCARE CORPANDA 21221920222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB - AYANA PHARMA LTDANDA 20722820212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB - ZYDUS LIFESCIENCESANDA 21229920202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB - DOXORUBICIN HYDROCHLORIDEHISUN PHARM HANGZHOUANDA 2060622019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/VIAL INJECTABLE INJECTION Discontinued — - DOXORUBICIN HYDROCHLORIDEGLANDANDA 2098252017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP - DR REDDYSANDA 20865720172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB - DOXORUBICIN HYDROCHLORIDEAMNEALANDA 20888820172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/VIAL INJECTABLE INJECTION Rx AP 50MG/VIAL INJECTABLE INJECTION Rx AP - DOXORUBICIN HYDROCHLORIDEACTAVIS INCANDA 20362220142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP 200MG/100ML INJECTABLE INJECTION Rx AP - DOXORUBICIN HYDROCHLORIDESAGENT PHARMSANDA 0914952013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP - SUN PHARMANDA 20326320132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL INJECTION Rx AB - DOXORUBICIN HYDROCHLORIDEALMAJECTANDA 0655152012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — - DOXORUBICIN HYDROCHLORIDEHLTHCAREANDA 2001462012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — - DOXORUBICIN HYDROCHLORIDESUN PHARM INDSANDA 0914182012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP - DOXORUBICIN HYDROCHLORIDEPHARMOBEDIENTANDA 2009012012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — - DOXORUBICIN HYDROCHLORIDEMYLAN LABS LTDANDA 20017020112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/VIAL INJECTABLE INJECTION Discontinued — 50MG/VIAL INJECTABLE INJECTION Rx AP - DOXORUBICIN HYDROCHLORIDEFRESENIUS KABI USAANDA 0632771995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP - DOXORUBICIN HYDROCHLORIDETEVA PHARMS USAANDA 06414019952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — 200MG/100ML INJECTABLE INJECTION Discontinued — - DOXORUBICIN HYDROCHLORIDEPHARMACHEMIE BVANDA 06333619952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — 200MG/100ML INJECTABLE INJECTION Discontinued — - DOXORUBICIN HYDROCHLORIDEHIKMAANDA 0640971994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML INJECTABLE INJECTION Rx AP - PFIZERANDA 06316519912 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — 200MG/100ML INJECTABLE INJECTION Discontinued — - DOXORUBICIN HYDROCHLORIDEPHARMACHEMIE BVANDA 06309719903 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/VIAL INJECTABLE INJECTION Discontinued — 20MG/VIAL INJECTABLE INJECTION Discontinued — 50MG/VIAL INJECTABLE INJECTION Discontinued — - BRISTOL MYERS SQUIBBANDA 06292619893 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/VIAL INJECTABLE INJECTION Discontinued — 50MG/VIAL INJECTABLE INJECTION Discontinued — 100MG/VIAL INJECTABLE INJECTION Discontinued — - DOXORUBICIN HYDROCHLORIDEHIKMAANDA 0629751989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP - DOXORUBICIN HYDROCHLORIDERSHIKMAANDA 06292119893 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/VIAL INJECTABLE INJECTION Rx — 20MG/VIAL INJECTABLE INJECTION Rx AP 50MG/VIAL INJECTABLE INJECTION Rx AP
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
41 yr 10 mo ago
Most recent approval
7 mo ago
Approvals span 1985–2026 across 30 FDA applications.
Brand (NDA) 310%
Generic (ANDA) 2790%
Doxorubicin 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
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- 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.
