Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020164
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOVENOX | ENOXAPARIN SODIUM | 300MG/3ML (100MG/ML) | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | AB | Yes | No |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | AP | Yes | No |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | AP | Yes | No |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | AP | Yes | No |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | AP | Yes | No |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | AP | Yes | Yes |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;SUBCUTANEOUS | Discontinued | None | Yes | No |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | AP | Yes | No |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 03/29/1993 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/20-164_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/pre96/20-164ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-164_review.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/01/2022 | SUPPL-131 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020164Orig1s131lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020164Orig1s131ltr.pdf | |
| 12/20/2021 | SUPPL-129 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020164s129lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020164Orig1s129ltr.pdf | |
| 12/11/2018 | SUPPL-116 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020164s116lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020164Orig1s116ltr.pdf | |
| 10/26/2017 | SUPPL-110 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020164s110lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020164Orig1s110ltr.pdf | |
| 01/30/2017 | SUPPL-108 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/2015 | SUPPL-107 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/2015 | SUPPL-106 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/2014 | SUPPL-105 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/2013 | SUPPL-103 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/2013 | SUPPL-102 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020164s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020164Orig1s102ltr.pdf | |
| 07/28/2023 | SUPPL-101 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020164Orig1s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020164Orig1s101ltr.pdf | |
| 06/05/2013 | SUPPL-100 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020164s100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020164Orig1s100ltr.pdf | |
| 11/28/2012 | SUPPL-99 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/2013 | SUPPL-98 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/2011 | SUPPL-93 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020164s093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020164s093ltr.pdf | |
| 04/13/2011 | SUPPL-92 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020164s092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020164s092ltr.pdf | |
| 12/06/2012 | SUPPL-89 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/2009 | SUPPL-85 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020164s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020164s085ltr.pdf | |
| 07/27/2009 | SUPPL-83 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020164s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020164s083ltr.pdf | |
| 07/16/2008 | SUPPL-80 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020164s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020164s080ltr.pdf | |
| 12/10/2012 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/2007 | SUPPL-75 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022138,020164s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022138s000,020164s075ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022138_020164_lovenox_enoxaparin_sodium_toc.cfm | |
| 01/12/2007 | SUPPL-70 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020164s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020164s070ltr.pdf | |
| 03/07/2005 | SUPPL-63 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20164s063ltr.pdf |
| 04/21/2004 | SUPPL-58 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20164slr058ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020164_S058_LOVENOX INJECTION_AP.pdf |
| 05/18/2004 | SUPPL-57 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20164slr057ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020164_S057_LOVENOX INJECION_AP.pdf |
| 04/13/2004 | SUPPL-56 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20164slr056ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020164_S056_LOVENOX INJ.pdf |
| 07/23/2004 | SUPPL-55 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20164s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20164s055ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020164_S055_Lovenox_Approval_Package.pdf | |
| 10/20/2004 | SUPPL-53 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20164s053ltr.pdf |
| 06/20/2003 | SUPPL-51 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20164slr051ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020164_S051_LOVENOX INJ.pdf |
| 07/01/2003 | SUPPL-50 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20164slr050ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020164_S050_LOVENOX INJ.pdf |
| 12/18/2003 | SUPPL-48 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20164slr048ltr.pdf |
| 01/09/2002 | SUPPL-46 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20164s40s45s46ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020164_S040&045&046_LOVENOX INJ.pdf |
| 01/09/2002 | SUPPL-45 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20164s40s45s46ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020164_S040&045&046_LOVENOX INJ.pdf |
| 11/30/2001 | SUPPL-44 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020164_S044_LOVENOX INJ.pdf |
| 01/23/2003 | SUPPL-43 | Manufacturing (CMC) |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20164scm043ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020164_S043_LOVENOX_INJECTION.pdf |
| 07/05/2001 | SUPPL-42 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020164_S042_LOVENOX_INJECTION.pdf |
| 12/14/2000 | SUPPL-41 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020164_S041_LOVENOX_INJECTION.pdf |
| 01/09/2002 | SUPPL-40 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20164s40s45s46ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020164_S040&045&046_LOVENOX INJ.pdf |
| 10/24/2000 | SUPPL-39 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020164_S039_LOVENOX_INJECTION.pdf |
| 06/20/2000 | SUPPL-38 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020164_S038_LOVENOX_INJECTION.pdf |
| 11/17/2000 | SUPPL-37 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20164S36lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20164S36ltr.pdf | |
| 11/17/2000 | SUPPL-36 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20164S36lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20164S36ltr.pdf | |
| 04/04/2000 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/30/2000 | SUPPL-34 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20164S34ltr.pdf |
| 01/27/2000 | SUPPL-32 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020164_S032_LOVENOX_INJECTION.pdf |
| 10/05/1999 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 06/02/2000 | SUPPL-30 | Manufacturing (CMC)-Formulation |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020164_S030_LOVENOX_INJECTION.pdf |
| 09/28/1999 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 10/05/1999 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/14/1999 | SUPPL-26 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S026_LOVENOX.pdf |
| 07/22/1999 | SUPPL-24 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S024_LOVENOX.pdf |
| 11/08/1999 | SUPPL-23 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S023_LOVENOX_INJECTION.pdf |
| 07/21/1999 | SUPPL-22 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S022_LOVENOX.pdf |
| 04/20/1999 | SUPPL-21 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S021_LOVENOX.pdf |
| 08/03/2000 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20164S20LTR.PDF |
| 03/03/1999 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020164_S019_LOVENOX.pdf |
| 05/27/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 03/27/1998 | SUPPL-16 | Efficacy-New Indication |
Label is not available on this site. |
||
| 12/31/1998 | SUPPL-15 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20164s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20164s15ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20164S15_Lovenox.cfm | |
| 01/27/1997 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 05/16/1997 | SUPPL-13 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020164_S013_LOVENOX_INJECTION.pdf |
| 10/23/1996 | SUPPL-12 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020164_S012_LOVENOX_INJECTION.pdf |
| 02/24/1998 | SUPPL-11 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020164_S011_LOVENOX.pdf |
| 01/30/1998 | SUPPL-10 | Efficacy-New Indication |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20164S10_lovenox_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20164S10_lovenox.cfm |
| 06/26/1996 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020164_S009_LOVENOX INJ.pdf |
| 05/06/1997 | SUPPL-8 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/07/1997 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/27/1997 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 01/30/1996 | SUPPL-5 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020164_S005_LOVENOX INJ.pdf |
| 03/15/1996 | SUPPL-4 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020164_S004_LOVENOX_INJECTION.pdf |
| 03/09/1995 | SUPPL-2 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/14/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/28/2023 | SUPPL-101 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020164Orig1s101lbl.pdf | |
| 12/01/2022 | SUPPL-131 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020164Orig1s131lbl.pdf | |
| 12/20/2021 | SUPPL-129 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020164s129lbl.pdf | |
| 12/11/2018 | SUPPL-116 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020164s116lbl.pdf | |
| 10/26/2017 | SUPPL-110 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020164s110lbl.pdf | |
| 10/23/2013 | SUPPL-102 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020164s102lbl.pdf | |
| 06/05/2013 | SUPPL-100 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020164s100lbl.pdf | |
| 04/20/2011 | SUPPL-93 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020164s093lbl.pdf | |
| 04/13/2011 | SUPPL-92 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020164s092lbl.pdf | |
| 12/23/2009 | SUPPL-85 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020164s085lbl.pdf | |
| 07/27/2009 | SUPPL-83 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020164s083lbl.pdf | |
| 07/16/2008 | SUPPL-80 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020164s080lbl.pdf | |
| 05/16/2007 | SUPPL-75 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022138,020164s075lbl.pdf | |
| 01/12/2007 | SUPPL-70 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020164s070lbl.pdf | |
| 01/12/2007 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020164s070lbl.pdf | |
| 07/23/2004 | SUPPL-55 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20164s055lbl.pdf |
| 11/17/2000 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20164S36lbl.pdf | |
| 11/17/2000 | SUPPL-36 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20164S36lbl.pdf | |
| 12/31/1998 | SUPPL-15 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20164s15lbl.pdf | |
| 03/29/1993 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/20-164_lbl.pdf |
LOVENOX
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS; 300MG/3ML (100MG/ML)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM | ENOXAPARIN SODIUM | 300MG/3ML (100MG/ML) | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AB | 208600 | AMPHASTAR PHARMS INC |
| ENOXAPARIN SODIUM | ENOXAPARIN SODIUM | 300MG/3ML (100MG/ML) | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AB | 214856 | NANJING KING-FRIEND |
| ENOXAPARIN SODIUM | ENOXAPARIN SODIUM | 300MG/3ML (100MG/ML) | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AB | 078660 | SANDOZ INC |
| LOVENOX | ENOXAPARIN SODIUM | 300MG/3ML (100MG/ML) | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | Yes | AB | 020164 | SANOFI AVENTIS US |
LOVENOX (PRESERVATIVE FREE)
INJECTABLE;SUBCUTANEOUS; 30MG/0.3ML (100MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076684 | AMPHASTAR PHARM |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 214646 | BE PHARMS |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 078990 | GLAND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206834 | NANJING KING-FRIEND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 077857 | SANDOZ |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 205660 | SHENZHEN TECHDOW |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076726 | ZYDUS PHARMS |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 020164 | SANOFI AVENTIS US |
INJECTABLE;SUBCUTANEOUS; 40MG/0.4ML (100MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076684 | AMPHASTAR PHARM |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 214646 | BE PHARMS |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 078990 | GLAND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206834 | NANJING KING-FRIEND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 077857 | SANDOZ |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 205660 | SHENZHEN TECHDOW |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076726 | ZYDUS PHARMS |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 020164 | SANOFI AVENTIS US |
INJECTABLE;SUBCUTANEOUS; 60MG/0.6ML (100MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076684 | AMPHASTAR PHARM |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 214646 | BE PHARMS |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 078990 | GLAND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206834 | NANJING KING-FRIEND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 077857 | SANDOZ |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 205660 | SHENZHEN TECHDOW |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076726 | ZYDUS PHARMS |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 020164 | SANOFI AVENTIS US |
INJECTABLE;SUBCUTANEOUS; 80MG/0.8ML (100MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076684 | AMPHASTAR PHARM |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 214646 | BE PHARMS |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 078990 | GLAND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206834 | NANJING KING-FRIEND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 077857 | SANDOZ |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 205660 | SHENZHEN TECHDOW |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076726 | ZYDUS PHARMS |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 020164 | SANOFI AVENTIS US |
INJECTABLE;SUBCUTANEOUS; 100MG/ML (100MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076684 | AMPHASTAR PHARM |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 214646 | BE PHARMS |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 078990 | GLAND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206834 | NANJING KING-FRIEND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 077857 | SANDOZ |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 205660 | SHENZHEN TECHDOW |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076726 | ZYDUS PHARMS |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 020164 | SANOFI AVENTIS US |
INJECTABLE;SUBCUTANEOUS; 120MG/0.8ML (150MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076684 | AMPHASTAR PHARM |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 214646 | BE PHARMS |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 078990 | GLAND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206834 | NANJING KING-FRIEND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 077857 | SANDOZ |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 205660 | SHENZHEN TECHDOW |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076726 | ZYDUS PHARMS |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 020164 | SANOFI AVENTIS US |
INJECTABLE;SUBCUTANEOUS; 150MG/ML (150MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076684 | AMPHASTAR PHARM |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 214646 | BE PHARMS |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 078990 | GLAND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206834 | NANJING KING-FRIEND |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 077857 | SANDOZ |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 205660 | SHENZHEN TECHDOW |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 076726 | ZYDUS PHARMS |
| LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 020164 | SANOFI AVENTIS US |