Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020449
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAXOTERE DOCETAXEL 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
TAXOTERE DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
TAXOTERE DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
TAXOTERE DOCETAXEL 160MG/8ML (20MG/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
05/14/1996 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020449Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/06/2019 SUPPL-82 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020449s080s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020449Orig1s080,%20020449Orig1s082ltr.pdf
06/06/2019 SUPPL-80 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020449s080s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020449Orig1s080, 020449Orig1s082ltr.pdf
10/05/2018 SUPPL-79 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020449s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020449Orig1s079ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/020449Orig1s079.pdf
12/11/2015 SUPPL-75 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020449s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020449Orig1s075ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020449Orig1s075.pdf
05/17/2016 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

11/14/2014 SUPPL-73 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020449s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020449Orig1s073ltr.pdf
05/15/2014 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

12/13/2013 SUPPL-71 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020449Orig1s071ltr.pdf
08/15/2013 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

06/26/2013 SUPPL-69 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020449Orig1s069ltr.pdf
11/21/2012 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

12/15/2011 SUPPL-65 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020449s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020449s065ltr.pdf
09/07/2011 SUPPL-64 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020449s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020449s064ltr.pdf
04/13/2012 SUPPL-63 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020449s063lbl.pdf
05/13/2010 SUPPL-59 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s059ltr.pdf
08/02/2010 SUPPL-54 Labeling-Container/Carton Labels, Labeling-Package Insert Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020449Orig1s054.pdf
04/20/2010 SUPPL-53 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s044,020449s053ltr.pdf
09/28/2007 SUPPL-45 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020449s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020449s045ltr.pdf
04/20/2010 SUPPL-44 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s044,020449s053ltr.pdf
06/03/2010 SUPPL-43 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020449s043ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020449Orig1s043.pdf
10/17/2006 SUPPL-39 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020449s039ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020449s039.pdf
06/07/2006 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020449s036LTR.pdf
03/22/2006 SUPPL-35 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449S035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020449S035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020449Orig1s035.pdf
11/05/2005 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020449s034ltr.pdf
08/11/2005 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020449s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020449s033ltr.pdf
01/06/2005 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20449s031ltr.pdf
08/18/2004 SUPPL-29 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020449s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20449s029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-449s029_Taxotere.cfm
05/19/2004 SUPPL-28 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020449s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20449se1-028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-449s028_Taxotere.cfm
01/30/2003 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr017,019,022ltr.pdf
07/30/2002 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr017,019,022ltr.pdf
11/27/2002 SUPPL-18 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20449se1-018_Taxotere_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20449se1-018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-449s018_Taxotere.cfm
07/09/2002 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr017,019,022ltr.pdf
04/24/2003 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020449s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20449slr016ltr.pdf
11/30/2000 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/28/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/23/1999 SUPPL-11 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20449S11LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20449S11LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20449-S011_Taxotere.cfm
03/31/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/18/1999 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1999 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/23/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/22/1998 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20449_ltr.pdf
06/22/1998 SUPPL-5 Efficacy-Accelerated Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20449_ltr.pdf
01/06/1998 SUPPL-4 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20449S004_Taxotere.pdf
05/15/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/22/1999 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/28/1997 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/06/2019 SUPPL-82 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020449s080s082lbl.pdf
06/06/2019 SUPPL-80 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020449s080s082lbl.pdf
10/05/2018 SUPPL-79 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020449s079lbl.pdf
12/11/2015 SUPPL-75 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020449s075lbl.pdf
12/11/2015 SUPPL-75 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020449s075lbl.pdf
11/14/2014 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020449s073lbl.pdf
12/13/2013 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s071lbl.pdf
06/26/2013 SUPPL-69 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s069lbl.pdf
04/13/2012 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020449s063lbl.pdf
12/15/2011 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020449s065lbl.pdf
09/07/2011 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020449s064lbl.pdf
05/13/2010 SUPPL-59 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s059lbl.pdf
04/20/2010 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s053lbl.pdf
04/20/2010 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s044lbl.pdf
09/28/2007 SUPPL-45 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020449s045lbl.pdf
10/17/2006 SUPPL-39 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s039lbl.pdf
06/07/2006 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s036lbl.pdf
03/22/2006 SUPPL-35 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449S035lbl.pdf
08/11/2005 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020449s033lbl.pdf
08/18/2004 SUPPL-29 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020449s029lbl.pdf
05/19/2004 SUPPL-28 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020449s028lbl.pdf
04/24/2003 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020449s016lbl.pdf
01/30/2003 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf
11/27/2002 SUPPL-18 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20449se1-018_Taxotere_lbl.pdf
07/30/2002 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf
07/09/2002 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20449slr022_taxotere_lbl.pdf
12/23/1999 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20449S11LBL.PDF

TAXOTERE

INJECTABLE;INJECTION; 20MG/ML (20MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 201195 ACCORD HLTHCARE
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203551 ACTAVIS LLC
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 209640 AMNEAL
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 206177 DFB ONCOLOGY LTD
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 204193 DR REDDYS LABS LTD
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 207252 JIANGSU HENGRUI MED
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 205934 TEIKOKU PHARMA
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203877 TEVA PHARMS USA
TAXOTERE DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020449 SANOFI AVENTIS US

INJECTABLE;INJECTION; 80MG/4ML (20MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 201195 ACCORD HLTHCARE
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203551 ACTAVIS LLC
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 209640 AMNEAL
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 206177 DFB ONCOLOGY LTD
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 204193 DR REDDYS LABS LTD
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 207252 JIANGSU HENGRUI MED
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 205934 TEIKOKU PHARMA
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203877 TEVA PHARMS USA
TAXOTERE DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020449 SANOFI AVENTIS US

INJECTABLE;INJECTION; 160MG/8ML (20MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 201195 ACCORD HLTHCARE
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203551 ACTAVIS LLC
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 209640 AMNEAL
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 207252 JIANGSU HENGRUI MED
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 208137 MYLAN LABS LTD
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 205934 TEIKOKU PHARMA
TAXOTERE DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020449 SANOFI AVENTIS US

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