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Serving leading biopharmaceutical companies globally:

Argus Health
US Department of Justice
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Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020388

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NDA 020388 describes NAVELBINE, which is a drug marketed by Pierre Fabre and is included in one NDA. It is available from one supplier. Additional details are available on the NAVELBINE profile page.

The generic ingredient in NAVELBINE 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 020388
Applicant:Pierre Fabre
Ingredient:vinorelbine tartrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 020388
Ingredient-typeVinca Alkaloids
Suppliers and Packaging for NDA: 020388
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAVELBINE vinorelbine tartrate INJECTABLE;INJECTION 020388 NDA Pierre Fabre Pharmaceuticals, Inc. 64370-532 N 64370-532-02
NAVELBINE vinorelbine tartrate INJECTABLE;INJECTION 020388 NDA Pierre Fabre Pharmaceuticals, Inc. 64370-532 N 64370-532-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Dec 23, 1994TE:APRLD:Yes

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Chinese Patent Office
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