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Covington
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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078011

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NDA 078011 describes VINORELBINE TARTRATE, which is a drug marketed by Actavis Totowa, Dr Reddys Labs Ltd, Ebewe Pharma, Fresenius Kabi Usa, Hospira, Jiangsu Hansoh Pharm, Mylan Labs Ltd, Teva Pharms Usa, and West-ward Pharms Int, and is included in ten NDAs. It is available from three suppliers. Additional details are available on the VINORELBINE TARTRATE profile page.

The generic ingredient in VINORELBINE TARTRATE is vinorelbine tartrate. There are fifteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the vinorelbine tartrate profile page.
Summary for 078011
Tradename:VINORELBINE TARTRATE
Applicant:Actavis Totowa
Ingredient:vinorelbine tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078011
Ingredient-typeVinca Alkaloids
Suppliers and Packaging for NDA: 078011
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VINORELBINE TARTRATE vinorelbine tartrate INJECTABLE;INJECTION 078011 ANDA Actavis Pharma, Inc. 45963-607 N 45963-607-55
VINORELBINE TARTRATE vinorelbine tartrate INJECTABLE;INJECTION 078011 ANDA Actavis Pharma, Inc. 45963-607 N 45963-607-56

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Jul 22, 2009TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
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US Army
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Federal Trade Commission
Daiichi Sankyo
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