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Last Updated: December 12, 2025

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, Ebewe Pharma, Fresenius Kabi Usa, Hikma, Hospira, Jiangsu Hansoh Pharm, Novast Labs, Rising, and Teva Pharms Usa, and is included in eleven NDAs. It is available from two 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. Two 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

Pharmacology for NDA: 091106

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	25021-204-01	1 VIAL in 1 CARTON (25021-204-01) / 1 mL in 1 VIAL
VINORELBINE TARTRATE	vinorelbine tartrate	INJECTABLE;INJECTION	091106	ANDA	Sagent Pharmaceuticals	25021-204	25021-204-05	1 VIAL in 1 CARTON (25021-204-05) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10MG BASE/ML
Approval Date:	Sep 26, 2012	TE:	AP	RLD:	No

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