Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076849
Company: FRESENIUS KABI USA
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
04/18/2005 ORIG-1 Approval

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
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 208997 INGENUS PHARMS LLC
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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