Last Updated: November 8, 2026

Details for New Drug Application (NDA): 076461

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NDA 076461 describes VINORELBINE TARTRATE, which is a drug marketed by Actavis Totowa, Dr Reddys, Ebewe Pharma, Fresenius Kabi Usa, Hikma, Hospira, Ingenus Pharms Llc, Jiangsu Hansoh Pharm, 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 is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the vinorelbine tartrate profile page.

Summary for 076461

Tradename:	VINORELBINE TARTRATE
Applicant:	Hikma
Ingredient:	vinorelbine tartrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10MG BASE/ML
Approval Date:	Dec 11, 2003	TE:	AP	RLD:	No

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