Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077356
Company: MEITHEAL

Products on ANDA 077356

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077356

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/11/2006	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77356ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2012	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
11/14/2012	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
11/12/2009	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077356

MITOXANTRONE HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 20MG BASE/10ML (EQ 2MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	077496	FRESENIUS KABI USA
MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076611	HIKMA
MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076871	HOSPIRA
MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	077356	MEITHEAL

INJECTABLE;INJECTION; EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	077496	FRESENIUS KABI USA
MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076611	HIKMA
MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076871	HOSPIRA
MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	077356	MEITHEAL

INJECTABLE;INJECTION; EQ 30MG BASE/15ML (EQ 2MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	077496	FRESENIUS KABI USA
MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076611	HIKMA
MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076871	HOSPIRA
MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	077356	MEITHEAL