Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076461
Company: HIKMA

Products on ANDA 076461

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VINORELBINE TARTRATE	VINORELBINE TARTRATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076461

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/11/2003	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 076461

VINORELBINE TARTRATE

INJECTABLE;INJECTION; EQ 10MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VINORELBINE TARTRATE	VINORELBINE TARTRATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	078011	ACTAVIS TOTOWA
VINORELBINE TARTRATE	VINORELBINE TARTRATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	202017	DR REDDYS
VINORELBINE TARTRATE	VINORELBINE TARTRATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075992	HIKMA
VINORELBINE TARTRATE	VINORELBINE TARTRATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	076461	HIKMA
VINORELBINE TARTRATE	VINORELBINE TARTRATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	091106	JIANGSU HANSOH PHARM