Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020388
Company: PIERRE FABRE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAVELBINE VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/23/1994 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/22/2018 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020388s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020388Orig1s035ltr.pdf
10/27/2016 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/21/2015 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/13/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/23/2014 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/14/2014 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020388s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020388Orig1s027ltr.pdf
11/05/2002 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20388S014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20388se8-014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020388_S014_NAVELBINE_INJECTION_AP.pdf
04/03/2002 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/29/2000 SUPPL-12 Labeling

Label is not available on this site.

08/25/2000 SUPPL-11 Labeling

Label is not available on this site.

10/02/2001 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20388s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20388s10ltr.pdf
05/12/2000 SUPPL-9 Labeling

Label is not available on this site.

06/08/2000 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-388S008_Navelbine_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-388S008_Navelbine_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-388s008_Navelbine.cfm
10/16/1998 SUPPL-7 Labeling

Label is not available on this site.

09/16/1998 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/06/1998 SUPPL-5 Labeling

Label is not available on this site.

04/16/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/29/1997 SUPPL-3 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/020388_S003_NAVELBINE INJECTION_AP.pdf
05/24/1996 SUPPL-2 Labeling

Label is not available on this site.

02/22/1996 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/22/2018 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020388s035lbl.pdf
03/14/2014 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020388s027lbl.pdf
11/05/2002 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20388S014lbl.pdf
10/02/2001 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20388s10lbl.pdf
06/08/2000 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-388S008_Navelbine_prntlbl.pdf

NAVELBINE

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 LABS LTD
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 076827 HOSPIRA
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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