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Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077356

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NDA 077356 describes MITOXANTRONE HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Oncol, West-ward Pharms Int, Mylan Labs Ltd, Teva Pharms Usa, Hospira, Mylan Institutional, and Fresenius Kabi Usa, and is included in seven NDAs. It is available from four suppliers. Additional details are available on the MITOXANTRONE HYDROCHLORIDE profile page.

The generic ingredient in MITOXANTRONE HYDROCHLORIDE is mitoxantrone hydrochloride. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the mitoxantrone hydrochloride profile page.

Summary for NDA: 077356

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 077356

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 077356

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MITOXANTRONE HYDROCHLORIDE
mitoxantrone hydrochloride
INJECTABLE;INJECTION 077356 ANDA Teva Parenteral Medicines, Inc. 0703-4680 0703-4680-01 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4680-01) > 12.5 mL in 1 VIAL, MULTI-DOSE
MITOXANTRONE HYDROCHLORIDE
mitoxantrone hydrochloride
INJECTABLE;INJECTION 077356 ANDA Teva Parenteral Medicines, Inc. 0703-4685 0703-4685-01 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4685-01) > 10 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 20MG BASE/10ML (EQ 2MG BASE/ML)
Approval Date:Apr 11, 2006TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)
Approval Date:Apr 11, 2006TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 30MG BASE/15ML (EQ 2MG BASE/ML)
Approval Date:Apr 11, 2006TE:APRLD:No


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