Orange Book product
MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)
Orange Book ANDA 078606 · FRESENIUS KABI ONCOLOGY PLC · Discontinued
Key facts
| Proprietary name | MITOXANTRONE HYDROCHLORIDE |
|---|---|
| Active ingredients | MITOXANTRONE HYDROCHLORIDE |
| Strength | EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA078606 |
| Applicant holder | FRESENIUS KABI ONCOLOGY PLC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | May 14, 2008 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.