Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091106
Company: JIANGSU HANSOH PHARM

Products on ANDA 091106

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091106

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/26/2012	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
08/20/2020	SUPPL-9	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
07/27/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
07/27/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/09/2013	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 091106

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