Orange Book product · Generic (ANDA)
MITOXANTRONE HYDROCHLORIDE
MITOXANTRONE HYDROCHLORIDE
At a glance
Apr 11, 2006
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 11, 2006
20 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
MITOXANTRONE HYDROCHLORIDE
Strength
EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 076871
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of MITOXANTRONE HYDROCHLORIDE
- 1987NOVANTRONEBrand (NDA)
NDA 019297 · EMD SERONO
- 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 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.
