Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020839
Company: SANOFI AVENTIS US
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 | No |
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 |
|---|---|---|---|---|---|
| 09/16/2022 | SUPPL-78 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020839s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020839Orig1s078ltr.pdf | |
| 09/12/2023 | SUPPL-75 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020839Orig1s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020839Orig1s075ltr.pdf | |
| 03/01/2021 | SUPPL-74 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020839s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020839Orig1s074ltr.pdf | |
| 05/17/2019 | SUPPL-72 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020839s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020839Orig1s072ltr.pdf | |
| 05/25/2018 | SUPPL-70 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020839s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020839Orig1s070ltr.pdf | |
| 10/11/2018 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020839s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020839Orig1s069Ltr.pdf | |
| 10/31/2017 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020839s068lbl.pdf | |
| 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/2015/020839s061_lbl.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 |
|---|---|---|---|---|---|
| 09/12/2023 | SUPPL-75 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020839Orig1s075lbl.pdf | |
| 09/12/2023 | SUPPL-75 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020839Orig1s075lbl.pdf | |
| 09/12/2023 | SUPPL-75 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020839Orig1s075lbl.pdf | |
| 09/16/2022 | SUPPL-78 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020839s078lbl.pdf | |
| 03/01/2021 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020839s074lbl.pdf | |
| 05/17/2019 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020839s072lbl.pdf | |
| 10/11/2018 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020839s069lbl.pdf | |
| 05/25/2018 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020839s070lbl.pdf | |
| 10/31/2017 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020839s068lbl.pdf | |
| 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/2015/020839s061_lbl.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 | 203632 | ALKEM LABS LTD |
| 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 | 076273 | DR REDDYS |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 205345 | HETERO LABS LTD V |
| 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 | 213351 | POLYGEN PHARMS |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 206376 | PRINSTON INC |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 204359 | RISING |
| 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 | 076999 | TEVA |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 090844 | TORRENT PHARMS LTD |
| 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 | 205345 | HETERO LABS LTD V |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 213351 | POLYGEN PHARMS |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 206376 | PRINSTON INC |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 204165 | SCIEGEN PHARMS INC |
| PLAVIX | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020839 | SANOFI AVENTIS US |