Composition
- Active ingredients
- MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- MITOXANTRONE HYDROCHLORIDE EQ 2MG BASE/ML · InjectableNDA021120-001 · Discontinued
- MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · InjectableNDA019297-002 · Discontinued
- MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · InjectableThis page
- MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · InjectableNDA019297-001 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA019297.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Novantrone
- Active substance
- mitoxantrone hydrochloride
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Emd Serono
- Status
- Discontinued
- FDA approval
- 23 Dec 1987
- Application
- NDA019297-003