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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 078408

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NDA 078408 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 078408

Tradename:	VINORELBINE TARTRATE
Applicant:	Ebewe Pharma
Ingredient:	vinorelbine tartrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10MG BASE/ML
Approval Date:	Feb 13, 2008	TE:		RLD:	No

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