APPLICATION
ANDA076611
TYPE
ANDA
ORIGINAL APPROVAL
2006-04-11
LATEST ACTION
2009-03-31
ROUTE
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
2009-03-31Labeling · Supplement 2AP
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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