Active ingredient
Mitoxantrone
4 finished FDA listings contain Mitoxantrone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MITOXANTRONE HYDROCHLORIDE
- Dosage forms
- Injection, Solution, Injection, Solution, Concentrate
- Routes
- Intravenous
- Manufacturers / labelers
- 3
- Strengths listed
- 2 mg/ml
- Brand names in FDA listings
- Mitoxantrone
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7005
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 077356 | MEITHEAL | 2006-04-11 | 2 |
| ANDA 076871 | HOSPIRA | 2006-04-11 | 1 |
| ANDA 077496 | FRESENIUS KABI USA | 2006-04-11 | 1 |
Official labeling on DailyMed
- MITOXANTRONE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] · version 25 · 2025-07-17
- MITOXANTRONE INJECTION, SOLUTION, CONCENTRATE [MEITHEAL PHARMACEUTICALS INC.] · version 1 · 2025-06-02
- MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 7 · 2024-10-21
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.