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FDA ANDA · ANDA077496

MITOXANTRONE

mitoxantrone hydrochloride

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA077496
TYPE
ANDA
ORIGINAL APPROVAL
2006-04-11
LATEST ACTION
2015-06-01
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

2015-06-01Labeling · Supplement 6 · standardAP
2011-04-26Labeling · Supplement 4AP
2006-04-11Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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