Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078011
Company: ACTAVIS TOTOWA
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
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
10/26/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

05/26/2010 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

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
NAVELBINE VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 020388 PIERRE FABRE
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 076849 FRESENIUS KABI USA
VINORELBINE TARTRATE VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 091106 JIANGSU HANSOH PHARM
VINORELBINE TARTRATE VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076028 TEVA PHARMS USA
VINORELBINE TARTRATE VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075992 WEST-WARD PHARMS INT
VINORELBINE TARTRATE VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076461 WEST-WARD PHARMS INT

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