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Federal Trade Commission
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US Army
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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091106

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NDA 091106 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 091106
Tradename:VINORELBINE TARTRATE
Applicant:Jiangsu Hansoh Pharm
Ingredient:vinorelbine tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091106
Ingredient-typeVinca Alkaloids
Suppliers and Packaging for NDA: 091106
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VINORELBINE TARTRATE vinorelbine tartrate INJECTABLE;INJECTION 091106 ANDA Sagent Pharmaceuticals 25021-204 N 25021-204-01
VINORELBINE TARTRATE vinorelbine tartrate INJECTABLE;INJECTION 091106 ANDA Sagent Pharmaceuticals 25021-204 N 25021-204-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Sep 26, 2012TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Daiichi Sankyo
Johnson and Johnson
QuintilesIMS
McKesson
Argus Health
Federal Trade Commission
Colorcon
Fish and Richardson

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