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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
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Generated: September 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076028

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NDA 076028 describes VINORELBINE TARTRATE, which is a drug marketed by Jiangsu Hansoh Pharm, Ebewe Pharma, Actavis Totowa, Dr Reddys Labs Ltd, Hospira, Teva Pharms Usa, Mylan Labs Ltd, Fresenius Kabi Usa, and West-ward Pharms Int, and is included in ten NDAs. It is available from six 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. Seven suppliers are listed for this compound. Additional details are available on the vinorelbine tartrate profile page.

Summary for NDA: 076028

Formulation / Manufacturing:see details

Pharmacology for NDA: 076028

Ingredient-typeVinca Alkaloids

Suppliers and Packaging for NDA: 076028

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
vinorelbine tartrate
INJECTABLE;INJECTION 076028 ANDA Teva Parenteral Medicines, Inc. 0703-4182 0703-4182-01 1 VIAL, SINGLE-USE in 1 CARTON (0703-4182-01) > 1 mL in 1 VIAL, SINGLE-USE
vinorelbine tartrate
INJECTABLE;INJECTION 076028 ANDA Teva Parenteral Medicines, Inc. 0703-4183 0703-4183-01 1 VIAL, SINGLE-USE in 1 CARTON (0703-4183-01) > 5 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Feb 3, 2003TE:APRLD:No

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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Daiichi Sankyo
US Department of Justice
Chinese Patent Office
Argus Health

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