Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020164
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FREE) ENOXAPARIN SODIUM 90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;SUBCUTANEOUS Discontinued None Yes No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
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
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-Package Insert, Labeling-Container/Carton Labels 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020164s070lbl.pdf
01/12/2007 SUPPL-70 Labeling-Container/Carton Labels 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 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 078990 APOTEX INC
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 076726 TEVA
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 078990 APOTEX INC
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 076726 TEVA
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 078990 APOTEX INC
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 076726 TEVA
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 078990 APOTEX INC
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 076726 TEVA
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 078990 APOTEX INC
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 076726 TEVA
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 078990 APOTEX INC
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 076726 TEVA
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 078990 APOTEX INC
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 076726 TEVA
LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM 150MG/ML (150MG/ML) INJECTABLE;SUBCUTANEOUS Prescription Yes AP 020164 SANOFI AVENTIS US

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