FDA Orange Book · active-ingredient family
Mitoxantrone hydrochloride
Mitoxantrone hydrochloride is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NOVANTRONE · NDA 019297
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NOVANTRONERLD×3 | EMD SERONO | NDA 019297 | — | Dec 23, 1987 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MITOXANTRONE HYDROCHLORIDE | RISING | ANDA 201014 | — | Dec 11, 2012 | |
| MITOXANTRONE HYDROCHLORIDE×2 | RISING | ANDA 078980 | — | Apr 13, 2009 | |
| MITOXANTRONE HYDROCHLORIDE×3 | FRESENIUS KABI ONCOL | ANDA 078606 | — | May 14, 2008 | |
| MITOXANTRONE HYDROCHLORIDE×3 | FRESENIUS KABI USA | ANDA 077496 | AP | Apr 11, 2006 | |
| MITOXANTRONE HYDROCHLORIDE×3 | HIKMA | ANDA 076611 | AP | Apr 11, 2006 | |
| MITOXANTRONE HYDROCHLORIDE×3 | HOSPIRA | ANDA 076871 | AP | Apr 11, 2006 | |
| MITOXANTRONE HYDROCHLORIDE×3 | MEITHEAL | ANDA 077356 | AP | Apr 11, 2006 |
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.
Mitoxantrone hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
