Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020839
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PLAVIX CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription AB Yes No
PLAVIX CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription AB 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
11/17/1997 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020839_s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/10/2017 SUPPL-67 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020839s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020839Orig1s067ltr.pdf
09/16/2016 SUPPL-64 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020839s062s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020839Orig1s062,s064ltr.pdf
03/24/2016 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

09/16/2016 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020839s062s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020839Orig1s062,s064ltr.pdf
07/16/2015 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020839s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020839Orig1s061ltr.pdf
05/14/2014 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

03/12/2014 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

12/12/2013 SUPPL-58 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020839s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020839Orig1s058ltr.pdf
09/12/2013 SUPPL-57 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020839s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020839Orig1s057ltr.pdf
05/24/2013 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

12/20/2011 SUPPL-55 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020839s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020839s055ltr.pdf
05/03/2011 SUPPL-53 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020839s053ltr.pdf
02/01/2011 SUPPL-52 REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020839s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020839s052ltr.pdf
05/06/2011 SUPPL-51 Efficacy-Pediatric Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020839s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020839s051ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020839Orig1s051TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020839Orig1s051SumR.pdf
08/24/2010 SUPPL-48 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020839s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020839s048ltr.pdf
11/12/2009 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020839s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020839s044ltr.pdf
03/12/2010 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020839s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020839s042ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020839Orig1s042.pdf
05/05/2009 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020839s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020839s040ltr.pdf
10/22/2007 SUPPL-39 Labeling-Container/Carton Labels

Label is not available on this site.

09/20/2007 SUPPL-38 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020839s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020839s038ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020839Orig1s038.pdf
05/01/2007 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020839s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020839s037ltr.pdf
08/04/2006 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020839s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020839s035LTR.pdf
08/17/2006 SUPPL-34 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020839s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020839s034LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020839_s034_plavix.pdf
10/14/2005 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s033ltr.pdf
04/25/2005 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s030,031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s030,031ltr.pdf
04/25/2005 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s030,031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s030,031ltr.pdf
04/26/2005 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020839s028ltr.pdf
09/29/2003 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20839slr021,024ltr.pdf
10/13/2004 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20839s023ltr.pdf
06/10/2002 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/29/2003 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20839slr021,024ltr.pdf
09/10/2002 SUPPL-20 Manufacturing (CMC)-Expiration Date Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020-839_S-020.PDF
02/27/2002 SUPPL-19 Efficacy-New Indication Label
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-839s019_ClopidogrelPlavix.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20839s19ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-839s019_ClopidogrelPlavix.cfm
01/28/2002 SUPPL-18 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20839s18ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020-839_S-018.PDF
12/05/2001 SUPPL-17 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-017.PDF
07/19/2001 SUPPL-16 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-016.PDF
06/18/2001 SUPPL-15 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-015.PDF
03/07/2001 SUPPL-14 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-014.PDF
03/07/2001 SUPPL-13 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-013.PDF
10/24/2000 SUPPL-11 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-011.PDF
11/09/2000 SUPPL-10 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-010.PDF
07/25/2000 SUPPL-9 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-009.PDF
04/28/2000 SUPPL-8 Labeling

Label is not available on this site.

07/10/2000 SUPPL-7 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-007.PDF
02/22/2000 SUPPL-6 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-006.PDF
03/15/2000 SUPPL-5 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-005.PDF
01/27/2000 SUPPL-4 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-004.PDF
08/20/1999 SUPPL-3 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020-839_S-003.PDF
05/21/1998 SUPPL-2 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020-839_S-002.PDF
05/12/1998 SUPPL-1 Manufacturing (CMC)-Expiration Date Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020-839_S-001.PDF
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/10/2017 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020839s067lbl.pdf
07/10/2017 SUPPL-67 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020839s067lbl.pdf
09/16/2016 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020839s062s064lbl.pdf
09/16/2016 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020839s062s064lbl.pdf
07/16/2015 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020839s061lbl.pdf
12/12/2013 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020839s058lbl.pdf
09/12/2013 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020839s057lbl.pdf
12/20/2011 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020839s055lbl.pdf
05/06/2011 SUPPL-51 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020839s051lbl.pdf
02/01/2011 SUPPL-52 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020839s052lbl.pdf
08/24/2010 SUPPL-48 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020839s048lbl.pdf
03/12/2010 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020839s042lbl.pdf
11/12/2009 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020839s044lbl.pdf
05/05/2009 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020839s040lbl.pdf
09/20/2007 SUPPL-38 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020839s038lbl.pdf
09/20/2007 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020839s038lbl.pdf
05/01/2007 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020839s037lbl.pdf
08/17/2006 SUPPL-34 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020839s034lbl.pdf
08/04/2006 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020839s035lbl.pdf
10/14/2005 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s033lbl.pdf
04/25/2005 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s030,031lbl.pdf
04/25/2005 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020839s030,031lbl.pdf
02/27/2002 SUPPL-19 Efficacy-New Indication https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-839s019_ClopidogrelPlavix.htm

PLAVIX

TABLET;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 202925 ACCORD HLTHCARE
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 078004 ACME LABS
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 203751 AMNEAL PHARMS
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 076274 APOTEX INC
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 090540 AUROBINDO PHARMA LTD
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 204359 CSPC OUYI PHARM CO
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 076273 DR REDDYS LABS INC
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 202928 MACLEODS PHARMS LTD
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 077665 MYLAN PHARMS INC
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 204165 SCIEGEN PHARMS INC
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 078133 SUN PHARM INDS
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 090494 SUN PHARMA GLOBAL
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 076999 TEVA
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 090844 TORRENT PHARMS LTD
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 202266 WOCKHARDT LTD
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 201686 ZYDUS PHARMS USA INC
PLAVIX CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription Yes AB 020839 SANOFI AVENTIS US

TABLET;ORAL; EQ 300MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 202925 ACCORD HLTHCARE
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 076274 APOTEX INC
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 091023 DR REDDYS LABS LTD
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 091216 GATE PHARMS
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 077665 MYLAN PHARMS INC
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 204165 SCIEGEN PHARMS INC
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 090625 TEVA PHARMS
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 202266 WOCKHARDT LTD
PLAVIX CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription Yes AB 020839 SANOFI AVENTIS US

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