SANOFI AVENTIS US FDA Approval NDA 020164

NDA 020164

SANOFI AVENTIS US

FDA Drug Application

Application #020164

Documents

Letter2004-06-08
Letter1998-12-31
Letter2000-08-04
Letter2000-09-27
Letter2000-11-17
Letter2002-01-09
Letter2003-12-23
Letter2003-07-08
Letter2003-07-06
Letter2004-05-26
Letter2005-03-10
Letter2007-01-16
Letter2011-04-15
Letter2011-04-22
Letter2013-06-07
Label2000-11-17
Label2004-07-28
Label2007-05-29
Label2008-07-22
Label2009-12-30
Label2011-04-21
Review2004-07-15
Review2008-08-11
Review2008-08-11
Review2008-08-11
Review2008-08-11
Review2008-08-08
Review2008-08-08
Review2008-08-08
Review2008-08-01
Review2008-08-04
Review2008-08-01
Review2006-10-26
Review2008-08-01
Review2009-03-24
Letter2004-02-25
Letter2000-11-17
Letter2002-01-09
Letter2003-01-23
Letter2002-01-09
Letter2004-10-26
Letter2004-07-28
Letter2004-04-20
Letter2004-04-29
Letter2007-05-29
Letter2008-07-18
Letter2009-07-31
Letter2009-12-31
Letter2013-10-25
Label2004-04-05
Label1998-12-31
Label2000-11-17
Label2007-01-16
Label2009-07-30
Label2011-04-19
Label2013-06-11
Label2013-10-31
Review2008-08-11
Review2003-04-29
Review2008-08-08
Review2000-07-03
Review2008-08-08
Review2008-08-08
Review2008-08-08
Review2008-08-04
Review2008-08-04
Review2008-08-04
Review2008-08-04
Review2008-08-04
Review2008-08-04
Review2008-08-04
Review2008-08-04
Review2008-08-04
Review2008-08-01
Review2007-07-09
Review2007-07-09
Other Important Information from FDA2013-11-07
Letter2017-10-31
Label2017-11-03
Label2018-12-12
Letter2018-12-20
Label2021-12-20
Letter2021-12-21
Letter2022-12-02
Label2022-12-05

Application Sponsors

NDA 020164SANOFI AVENTIS US

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Discontinued006
Prescription007
Prescription008
Prescription009

Application Products

001INJECTABLE;SUBCUTANEOUS30MG/0.3ML (100MG/ML)1LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUM
002INJECTABLE;SUBCUTANEOUS40MG/0.4ML (100MG/ML)1LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUM
003INJECTABLE;SUBCUTANEOUS60MG/0.6ML (100MG/ML)1LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUM
004INJECTABLE;SUBCUTANEOUS80MG/0.8ML (100MG/ML)1LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUM
005INJECTABLE;SUBCUTANEOUS100MG/ML (100MG/ML)1LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUM
006INJECTABLE;SUBCUTANEOUS90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUM
007INJECTABLE;SUBCUTANEOUS120MG/0.8ML (150MG/ML)1LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUM
008INJECTABLE;SUBCUTANEOUS150MG/ML (150MG/ML)1LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUM
009INJECTABLE;INTRAVENOUS, SUBCUTANEOUS300MG/3ML (100MG/ML)1LOVENOXENOXAPARIN SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1993-03-29PRIORITY
EFFICACY; EfficacySUPPL2AP1995-03-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1996-03-15PRIORITY
LABELING; LabelingSUPPL5AP1996-01-30STANDARD
LABELING; LabelingSUPPL6AP1997-05-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1997-03-07PRIORITY
EFFICACY; EfficacySUPPL8AP1997-05-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1996-06-26PRIORITY
EFFICACY; EfficacySUPPL10AP1998-01-30UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1998-02-24PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1996-10-23PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1997-05-16PRIORITY
LABELING; LabelingSUPPL14AP1997-01-27STANDARD
EFFICACY; EfficacySUPPL15AP1998-12-31STANDARD
EFFICACY; EfficacySUPPL16AP1998-03-27PRIORITY
LABELING; LabelingSUPPL17AP1997-05-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1999-03-03PRIORITY
EFFICACY; EfficacySUPPL20AP2000-08-03UNKNOWN
LABELING; LabelingSUPPL21AP1999-04-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP1999-07-21PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL23AP1999-11-08PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL24AP1999-07-22PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL26AP1999-09-14PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL27AP1999-10-05PRIORITY
LABELING; LabelingSUPPL28AP1999-09-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL30AP2000-06-02PRIORITY
LABELING; LabelingSUPPL31AP1999-10-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL32AP2000-01-27PRIORITY
EFFICACY; EfficacySUPPL34AP2000-05-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL35AP2000-04-04PRIORITY
EFFICACY; EfficacySUPPL36AP2000-11-17PRIORITY
LABELING; LabelingSUPPL37AP2000-11-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL38AP2000-06-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL39AP2000-10-24PRIORITY
LABELING; LabelingSUPPL40AP2002-01-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL41AP2000-12-14PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL42AP2001-07-05PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL43AP2003-01-23PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL44AP2001-11-30PRIORITY
LABELING; LabelingSUPPL45AP2002-01-09STANDARD
LABELING; LabelingSUPPL46AP2002-01-09STANDARD
LABELING; LabelingSUPPL48AP2003-12-18STANDARD
LABELING; LabelingSUPPL50AP2003-07-01STANDARD
LABELING; LabelingSUPPL51AP2003-06-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL53AP2004-10-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL55AP2004-07-23PRIORITY
LABELING; LabelingSUPPL56AP2004-04-13STANDARD
LABELING; LabelingSUPPL57AP2004-05-18STANDARD
LABELING; LabelingSUPPL58AP2004-04-21STANDARD
LABELING; LabelingSUPPL63AP2005-03-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL70AP2007-01-12N/A
LABELING; LabelingSUPPL75AP2007-05-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL79AP2012-12-10PRIORITY
LABELING; LabelingSUPPL80AP2008-07-16STANDARD
LABELING; LabelingSUPPL83AP2009-07-27STANDARD
LABELING; LabelingSUPPL85AP2009-12-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL89AP2012-12-06PRIORITY
LABELING; LabelingSUPPL92AP2011-04-13STANDARD
LABELING; LabelingSUPPL93AP2011-04-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL98AP2013-09-06PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL99AP2012-11-28PRIORITY
LABELING; LabelingSUPPL100AP2013-06-05STANDARD
LABELING; LabelingSUPPL102AP2013-10-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL103AP2013-09-27PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL105AP2014-05-29PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL106AP2015-08-03PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL107AP2015-08-24PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL108AP2017-01-30STANDARD
LABELING; LabelingSUPPL110AP2017-10-26STANDARD
LABELING; LabelingSUPPL116AP2018-12-11STANDARD
LABELING; LabelingSUPPL129AP2021-12-20STANDARD
LABELING; LabelingSUPPL131AP2022-12-01STANDARD

Submissions Property Types

SUPPL4Null0
SUPPL7Null0
SUPPL9Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL19Null0
SUPPL22Null0
SUPPL23Null0
SUPPL24Null0
SUPPL26Null0
SUPPL27Null0
SUPPL30Null0
SUPPL32Null0
SUPPL35Null0
SUPPL38Null0
SUPPL39Null0
SUPPL41Null0
SUPPL42Null0
SUPPL43Null0
SUPPL44Null0
SUPPL53Null0
SUPPL55Null0
SUPPL79Null0
SUPPL83Null6
SUPPL85Null6
SUPPL89Null0
SUPPL92Null6
SUPPL93Null6
SUPPL98Null0
SUPPL99Null0
SUPPL100Null15
SUPPL102Null15
SUPPL103Null0
SUPPL105Null0
SUPPL106Null0
SUPPL107Null0
SUPPL110Null7
SUPPL116Null15
SUPPL129Null7
SUPPL131Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP
004PrescriptionAP
005PrescriptionAP
007PrescriptionAP
008PrescriptionAP
009PrescriptionAB

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
        )

)

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