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FREE) | ENOXAPARIN SODIUM | 90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;SUBCUTANEOUS | Discontinued | None | Yes | No |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 |
| 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 |