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FDA ANDA · ANDA078980

MITOXANTRONE HYDROCHLORIDE

Sponsor: RISING

APPLICATION
ANDA078980
TYPE
ANDA
ORIGINAL APPROVAL
2009-04-13
LATEST ACTION
2009-08-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

MITOXANTRONE HYDROCHLORIDEDiscontinued
MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) · INJECTABLE · INJECTION
MITOXANTRONE HYDROCHLORIDEDiscontinued
MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) · INJECTABLE · INJECTION

Approval history

2009-08-20Labeling · Supplement 2AP
2009-04-13OriginalAP
VIEW ON DRUGS@FDA ↗

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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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