APPLICATION
ANDA076871
TYPE
ANDA
ORIGINAL APPROVAL
2006-04-11
LATEST ACTION
2017-03-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
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
MITOXANTRONE HYDROCHLORIDEPrescription
MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) · INJECTABLE · INJECTION
Approval history
2017-03-24Manufacturing (CMC) · Supplement 14 · unknownAP
2015-01-30Manufacturing (CMC) · Supplement 12 · unknownAP
2014-12-05Labeling · Supplement 9 · standardAP
2012-11-13Labeling · Supplement 8AP
2009-08-20Labeling · Supplement 6AP
2009-08-20Labeling · Supplement 5AP
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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