APPLICATION
ANDA077356
TYPE
ANDA
ORIGINAL APPROVAL
2006-04-11
LATEST ACTION
2012-12-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MITOXANTRONE HYDROCHLORIDEPrescription
MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) · INJECTABLE · INJECTION
MITOXANTRONE HYDROCHLORIDEPrescription
MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) · INJECTABLE · INJECTION
MITOXANTRONE HYDROCHLORIDEPrescription
MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) · INJECTABLE · INJECTION
Approval history
2012-12-05Labeling · Supplement 20 · standardAP
2012-11-14Labeling · Supplement 16AP
2009-11-12Labeling · Supplement 4AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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