Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202017
Company: DR REDDYS

Products on ANDA 202017

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 202017

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/12/2013	ORIG-1	Approval	Not Applicable			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-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202017

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