FDA Orange Book
Generic for Novantrone
Novantrone contains mitoxantrone. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Novantrone is mitoxantrone. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Novantrone products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 20MG BASE/10ML (EQ 2MG BASE/ML) | Discontinued | None | 4 | AP |
| injectable, injection | EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) | Discontinued | None | 4 | AP |
| injectable, injection | EQ 30MG BASE/15ML (EQ 2MG BASE/ML) | Discontinued | None | 4 | AP |
NDA 019297, held by EMD SERONO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic mitoxantrone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 077496 | AP (A-rated, therapeutically equivalent) | April 11, 2006 | EQ 20MG BASE/10ML (EQ 2MG BASE/ML), EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML), EQ 30MG BASE/15ML (EQ 2MG BASE/ML) |
| HIKMA PHARMACEUTICALS USA INC | 076611 | AP (A-rated, therapeutically equivalent) | April 11, 2006 | EQ 20MG BASE/10ML (EQ 2MG BASE/ML), EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML), EQ 30MG BASE/15ML (EQ 2MG BASE/ML) |
| HOSPIRA WORLDWIDE, INC | 076871 | AP (A-rated, therapeutically equivalent) | April 11, 2006 | EQ 20MG BASE/10ML (EQ 2MG BASE/ML), EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML), EQ 30MG BASE/15ML (EQ 2MG BASE/ML) |
| MEITHEAL PHARMACEUTICALS INC | 077356 | AP (A-rated, therapeutically equivalent) | April 11, 2006 | EQ 20MG BASE/10ML (EQ 2MG BASE/ML), EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML), EQ 30MG BASE/15ML (EQ 2MG BASE/ML) |
Questions
Is there a generic for Novantrone?
Yes. The generic name for Novantrone is mitoxantrone. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Novantrone?
The active ingredient in Novantrone is mitoxantrone, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.