Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 201023
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JEVTANA KIT CABAZITAXEL 60MG/1.5ML (40MG/ML) SOLUTION;INTRAVENOUS Prescription None 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
06/17/2010 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/201023s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201023s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201023s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/09/2018 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201023s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201023Orig1s021ltr.pdf
05/17/2017 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201023s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201023Orig1sS020ltr.pdf
09/14/2017 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201023s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201023Orig1s019ltr.pdf
09/12/2016 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201023s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201023Orig1s017ltr.pdf
05/27/2016 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/18/2015 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201023s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201023Orig1s015ltr.pdf
06/11/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/05/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/14/2014 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

11/19/2014 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201023s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201023Orig1s011ltr.pdf
03/14/2014 SUPPL-10 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

09/11/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/13/2013 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/25/2013 SUPPL-7 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201023Orig1s007ltr.pdf
10/04/2012 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201023s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201023Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/09/2018 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201023s021lbl.pdf
09/14/2017 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201023s019lbl.pdf
05/17/2017 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201023s020lbl.pdf
09/12/2016 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201023s017lbl.pdf
06/18/2015 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201023s015lbl.pdf
11/19/2014 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201023s011lbl.pdf
10/04/2012 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201023s003lbl.pdf
06/17/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201023lbl.pdf

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