FDA Orange Book · active-ingredient family
Mitoxantrone hydrochloride
Mitoxantrone hydrochloride: 1 brand, 7 generics; first approved Dec 23, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 7 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
7
Listed patents
0
Presentations
21
Brand (NDA) products
Originator applications
- NOVANTRONERLDEMD SERONONDA 01929719873 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Discontinued — EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Discontinued — EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (7)
Abbreviated applications
- MITOXANTRONE HYDROCHLORIDERISINGANDA 2010142012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Discontinued — - MITOXANTRONE HYDROCHLORIDERISINGANDA 07898020092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Discontinued — EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Discontinued — - MITOXANTRONE HYDROCHLORIDEFRESENIUS KABI ONCOLANDA 07860620083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Discontinued — EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Discontinued — EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Discontinued — - MITOXANTRONE HYDROCHLORIDEFRESENIUS KABI USAANDA 07749620063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Rx AP - MITOXANTRONE HYDROCHLORIDEHIKMAANDA 07661120063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Rx AP - MITOXANTRONE HYDROCHLORIDERSHOSPIRAANDA 07687120063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Rx AP - MITOXANTRONE HYDROCHLORIDEMEITHEALANDA 07735620063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) 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
39 yr 4 mo ago
Most recent approval
14 yr ago
Approvals span 1987–2012 across 8 FDA applications.
Brand (NDA) 113%
Generic (ANDA) 788%
Mitoxantrone 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.
