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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201023
Company: SANOFI AVENTIS US

Summary Review

Products on NDA 201023

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	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201023

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
07/07/2023	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201023s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201023Orig1s026ltr.pdf
02/12/2021	SUPPL-25	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201023Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201023Orig1s025ltr.pdf
12/18/2020	SUPPL-24	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201023Orig1s024ltr.pdf
03/05/2020	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201023s023lbl.pdf
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-Patient Package Insert, Labeling-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

Labels for NDA 201023

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/07/2023	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201023s026lbl.pdf
02/12/2021	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201023Orig1s025lbl.pdf
02/12/2021	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201023Orig1s025lbl.pdf
12/18/2020	SUPPL-24	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201023s024lbl.pdf
03/05/2020	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201023s023lbl.pdf
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

Therapeutic Equivalents for NDA 201023

JEVTANA KIT

SOLUTION;INTRAVENOUS; 60MG/1.5ML (40MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CABAZITAXEL	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207693	ACCORD HLTHCARE
CABAZITAXEL	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207718	DR REDDYS
JEVTANA KIT	CABAZITAXEL	60MG/1.5ML (40MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	201023	SANOFI AVENTIS US

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