Documents
Application Sponsors
NDA 020164 | SANOFI AVENTIS US | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Discontinued | 006 |
Prescription | 007 |
Prescription | 008 |
Prescription | 009 |
Application Products
001 | INJECTABLE;SUBCUTANEOUS | 30MG/0.3ML (100MG/ML) | 1 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM |
002 | INJECTABLE;SUBCUTANEOUS | 40MG/0.4ML (100MG/ML) | 1 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM |
003 | INJECTABLE;SUBCUTANEOUS | 60MG/0.6ML (100MG/ML) | 1 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM |
004 | INJECTABLE;SUBCUTANEOUS | 80MG/0.8ML (100MG/ML) | 1 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM |
005 | INJECTABLE;SUBCUTANEOUS | 100MG/ML (100MG/ML) | 1 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM |
006 | INJECTABLE;SUBCUTANEOUS | 90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM |
007 | INJECTABLE;SUBCUTANEOUS | 120MG/0.8ML (150MG/ML) | 1 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM |
008 | INJECTABLE;SUBCUTANEOUS | 150MG/ML (150MG/ML) | 1 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM |
009 | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 300MG/3ML (100MG/ML) | 1 | LOVENOX | ENOXAPARIN SODIUM |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1993-03-29 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 2 | AP | 1995-03-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1996-03-15 | PRIORITY |
LABELING; Labeling | SUPPL | 5 | AP | 1996-01-30 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 1997-05-27 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1997-03-07 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 8 | AP | 1997-05-06 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1996-06-26 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 10 | AP | 1998-01-30 | UNKNOWN |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1998-02-24 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1996-10-23 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1997-05-16 | PRIORITY |
LABELING; Labeling | SUPPL | 14 | AP | 1997-01-27 | STANDARD |
EFFICACY; Efficacy | SUPPL | 15 | AP | 1998-12-31 | STANDARD |
EFFICACY; Efficacy | SUPPL | 16 | AP | 1998-03-27 | PRIORITY |
LABELING; Labeling | SUPPL | 17 | AP | 1997-05-27 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1999-03-03 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 20 | AP | 2000-08-03 | UNKNOWN |
LABELING; Labeling | SUPPL | 21 | AP | 1999-04-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1999-07-21 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1999-11-08 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1999-07-22 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1999-09-14 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1999-10-05 | PRIORITY |
LABELING; Labeling | SUPPL | 28 | AP | 1999-09-28 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2000-06-02 | PRIORITY |
LABELING; Labeling | SUPPL | 31 | AP | 1999-10-05 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2000-01-27 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 34 | AP | 2000-05-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2000-04-04 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 36 | AP | 2000-11-17 | PRIORITY |
LABELING; Labeling | SUPPL | 37 | AP | 2000-11-17 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2000-06-20 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2000-10-24 | PRIORITY |
LABELING; Labeling | SUPPL | 40 | AP | 2002-01-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 2000-12-14 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 2001-07-05 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 2003-01-23 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2001-11-30 | PRIORITY |
LABELING; Labeling | SUPPL | 45 | AP | 2002-01-09 | STANDARD |
LABELING; Labeling | SUPPL | 46 | AP | 2002-01-09 | STANDARD |
LABELING; Labeling | SUPPL | 48 | AP | 2003-12-18 | STANDARD |
LABELING; Labeling | SUPPL | 50 | AP | 2003-07-01 | STANDARD |
LABELING; Labeling | SUPPL | 51 | AP | 2003-06-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 2004-10-20 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 2004-07-23 | PRIORITY |
LABELING; Labeling | SUPPL | 56 | AP | 2004-04-13 | STANDARD |
LABELING; Labeling | SUPPL | 57 | AP | 2004-05-18 | STANDARD |
LABELING; Labeling | SUPPL | 58 | AP | 2004-04-21 | STANDARD |
LABELING; Labeling | SUPPL | 63 | AP | 2005-03-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 70 | AP | 2007-01-12 | N/A |
LABELING; Labeling | SUPPL | 75 | AP | 2007-05-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 79 | AP | 2012-12-10 | PRIORITY |
LABELING; Labeling | SUPPL | 80 | AP | 2008-07-16 | STANDARD |
LABELING; Labeling | SUPPL | 83 | AP | 2009-07-27 | STANDARD |
LABELING; Labeling | SUPPL | 85 | AP | 2009-12-23 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 89 | AP | 2012-12-06 | PRIORITY |
LABELING; Labeling | SUPPL | 92 | AP | 2011-04-13 | STANDARD |
LABELING; Labeling | SUPPL | 93 | AP | 2011-04-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 98 | AP | 2013-09-06 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 99 | AP | 2012-11-28 | PRIORITY |
LABELING; Labeling | SUPPL | 100 | AP | 2013-06-05 | STANDARD |
LABELING; Labeling | SUPPL | 102 | AP | 2013-10-23 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 103 | AP | 2013-09-27 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 105 | AP | 2014-05-29 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 106 | AP | 2015-08-03 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 107 | AP | 2015-08-24 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 108 | AP | 2017-01-30 | STANDARD |
LABELING; Labeling | SUPPL | 110 | AP | 2017-10-26 | STANDARD |
LABELING; Labeling | SUPPL | 116 | AP | 2018-12-11 | STANDARD |
LABELING; Labeling | SUPPL | 129 | AP | 2021-12-20 | STANDARD |
LABELING; Labeling | SUPPL | 131 | AP | 2022-12-01 | STANDARD |
Submissions Property Types
SUPPL | 4 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 22 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 26 | Null | 0 |
SUPPL | 27 | Null | 0 |
SUPPL | 30 | Null | 0 |
SUPPL | 32 | Null | 0 |
SUPPL | 35 | Null | 0 |
SUPPL | 38 | Null | 0 |
SUPPL | 39 | Null | 0 |
SUPPL | 41 | Null | 0 |
SUPPL | 42 | Null | 0 |
SUPPL | 43 | Null | 0 |
SUPPL | 44 | Null | 0 |
SUPPL | 53 | Null | 0 |
SUPPL | 55 | Null | 0 |
SUPPL | 79 | Null | 0 |
SUPPL | 83 | Null | 6 |
SUPPL | 85 | Null | 6 |
SUPPL | 89 | Null | 0 |
SUPPL | 92 | Null | 6 |
SUPPL | 93 | Null | 6 |
SUPPL | 98 | Null | 0 |
SUPPL | 99 | Null | 0 |
SUPPL | 100 | Null | 15 |
SUPPL | 102 | Null | 15 |
SUPPL | 103 | Null | 0 |
SUPPL | 105 | Null | 0 |
SUPPL | 106 | Null | 0 |
SUPPL | 107 | Null | 0 |
SUPPL | 110 | Null | 7 |
SUPPL | 116 | Null | 15 |
SUPPL | 129 | Null | 7 |
SUPPL | 131 | Null | 15 |
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
003 | Prescription | AP |
004 | Prescription | AP |
005 | Prescription | AP |
007 | Prescription | AP |
008 | Prescription | AP |
009 | Prescription | AB |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 20164
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"LOVENOX","activeIngredients":"ENOXAPARIN SODIUM","strength":"300MG\/3ML (100MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LOVENOX (PRESERVATIVE FREE)","activeIngredients":"ENOXAPARIN SODIUM","strength":"30MG\/0.3ML (100MG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LOVENOX (PRESERVATIVE FREE)","activeIngredients":"ENOXAPARIN SODIUM","strength":"40MG\/0.4ML (100MG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LOVENOX (PRESERVATIVE FREE)","activeIngredients":"ENOXAPARIN SODIUM","strength":"60MG\/0.6ML (100MG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LOVENOX (PRESERVATIVE FREE)","activeIngredients":"ENOXAPARIN SODIUM","strength":"80MG\/0.8ML (100MG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LOVENOX (PRESERVATIVE FREE)","activeIngredients":"ENOXAPARIN SODIUM","strength":"100MG\/ML (100MG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"LOVENOX (PRESERVATIVE FREE)","activeIngredients":"ENOXAPARIN SODIUM","strength":"90MG\/0.6ML (150MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"LOVENOX (PRESERVATIVE FREE)","activeIngredients":"ENOXAPARIN SODIUM","strength":"120MG\/0.8ML (150MG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LOVENOX (PRESERVATIVE FREE)","activeIngredients":"ENOXAPARIN SODIUM","strength":"150MG\/ML (150MG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"12\/11\/2018","submission":"SUPPL-116","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020164s116lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2017","submission":"SUPPL-110","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020164s110lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2013","submission":"SUPPL-102","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020164s102lbl.pdf\"}]","notes":""},{"actionDate":"06\/05\/2013","submission":"SUPPL-100","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020164s100lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2011","submission":"SUPPL-93","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020164s093lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2011","submission":"SUPPL-92","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020164s092lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2009","submission":"SUPPL-85","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020164s085lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2009","submission":"SUPPL-83","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020164s083lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/2008","submission":"SUPPL-80","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020164s080lbl.pdf\"}]","notes":""},{"actionDate":"05\/16\/2007","submission":"SUPPL-75","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022138,020164s075lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2007","submission":"SUPPL-70","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020164s070lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2007","submission":"SUPPL-70","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020164s070lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2004","submission":"SUPPL-55","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20164s055lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"11\/17\/2000","submission":"SUPPL-37","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20164S36lbl.pdf\"}]","notes":""},{"actionDate":"11\/17\/2000","submission":"SUPPL-36","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20164S36lbl.pdf\"}]","notes":""},{"actionDate":"12\/31\/1998","submission":"SUPPL-15","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20164s15lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/1993","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/pre96\\\/20-164_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"LOVENOX","submission":"ENOXAPARIN SODIUM","actionType":"300MG\/3ML (100MG\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS, SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LOVENOX (PRESERVATIVE FREE)","submission":"ENOXAPARIN SODIUM","actionType":"30MG\/0.3ML (100MG\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LOVENOX (PRESERVATIVE FREE)","submission":"ENOXAPARIN SODIUM","actionType":"40MG\/0.4ML (100MG\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LOVENOX (PRESERVATIVE FREE)","submission":"ENOXAPARIN SODIUM","actionType":"60MG\/0.6ML (100MG\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LOVENOX (PRESERVATIVE FREE)","submission":"ENOXAPARIN SODIUM","actionType":"80MG\/0.8ML (100MG\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LOVENOX (PRESERVATIVE FREE)","submission":"ENOXAPARIN SODIUM","actionType":"100MG\/ML (100MG\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LOVENOX (PRESERVATIVE FREE)","submission":"ENOXAPARIN SODIUM","actionType":"90MG\/0.6ML (150MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"LOVENOX (PRESERVATIVE FREE)","submission":"ENOXAPARIN SODIUM","actionType":"120MG\/0.8ML (150MG\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LOVENOX (PRESERVATIVE FREE)","submission":"ENOXAPARIN SODIUM","actionType":"150MG\/ML (150MG\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-12-11
)
)