Orange Book product · Brand (NDA)
NOVANTRONE
MITOXANTRONE HYDROCHLORIDE
At a glance
Dec 23, 1987
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 23, 1987
39 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
MITOXANTRONE HYDROCHLORIDE
Strength
EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019297
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2012MITOXANTRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 201014 · RISING
- 2009MITOXANTRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 078980 · RISING
- 2008MITOXANTRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 078606 · FRESENIUS KABI ONCOL
- 2006MITOXANTRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 077496 · FRESENIUS KABI USA
- 2006MITOXANTRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 076611 · HIKMA
- 2006MITOXANTRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 076871 · HOSPIRA
- 2006MITOXANTRONE HYDROCHLORIDEGeneric (ANDA)
ANDA 077356 · MEITHEAL
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.
