Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078011
Company: ACTAVIS TOTOWA

Products on ANDA 078011

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 078011

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/22/2009	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/27/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
07/27/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
10/26/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
05/26/2010	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078011

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