Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077356
Company: TEVA PHARMS USA
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
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.

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 076871 HOSPIRA
MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 077356 TEVA PHARMS USA
MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 076611 WEST-WARD PHARMS INT

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 076871 HOSPIRA
MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 077356 TEVA PHARMS USA
MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 076611 WEST-WARD PHARMS INT

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 076871 HOSPIRA
MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 077356 TEVA PHARMS USA
MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 076611 WEST-WARD PHARMS INT

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