SANOFI AVENTIS US FDA Approval NDA 020839

NDA 020839

SANOFI AVENTIS US

FDA Drug Application

Application #020839

Documents

Letter2002-01-28
Letter2003-10-09
Letter2004-10-15
Letter2003-10-09
Letter2005-04-28
Letter2005-04-28
Letter2005-10-19
Letter2007-05-09
Letter2007-09-25
Letter2010-01-20
Letter2010-08-16
Letter2011-05-10
Letter2011-02-07
Letter2011-05-06
Letter2011-12-22
Letter2013-09-13
Letter2015-07-20
Label2002-02-27
Label2005-04-28
Label2005-04-28
Label2005-10-19
Label2006-08-07
Label2010-03-12
Label2013-09-17
Label2013-12-17
Label2015-07-17
Review2010-03-04
Review2005-08-04
Review2005-08-04
Review2005-08-04
Review2005-08-04
Review2005-08-04
Review2005-08-04
Review2005-08-04
Review2005-08-04
Review2006-08-17
Other Important Information from FDA2010-08-09
Summary Review2011-07-08
Letter2002-02-27
Letter2005-04-28
Letter2006-08-21
Letter2006-08-07
Letter2009-08-26
Letter2010-03-18
Letter2013-12-16
Label2006-08-18
Label2007-05-07
Label2007-09-26
Label2009-05-11
Label2009-11-16
Label2010-08-19
Label2011-05-06
Label2011-02-04
Label2011-12-23
Review2005-08-04
Review2005-08-04
Review2005-08-04
Review2005-08-04
Review2005-08-04
Review2005-08-04
Review2005-08-04
Review2005-08-04
Review2002-02-27
Review2005-08-04
Review2012-03-02
Review2011-07-08
Label2016-09-16
Label2016-09-16
Letter2016-09-21
Letter2016-09-21
Review2016-11-02
Label2017-07-13
Letter2017-07-13
Label2017-10-31
Pediatric Written Request2001-10-15
Pediatric Amendment 12007-08-24
Pediatric Statistical Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Letter2018-05-29
Label2018-05-29
Medication Guide2018-05-29
Label2018-10-12
Letter2018-10-15
Letter2019-05-20
Label2019-05-20
Medication Guide2019-05-20
Pediatric Other1900-01-01
Label2021-03-02
Medication Guide2021-03-02
Letter2021-03-02
Letter2022-09-19
Label2022-09-20

Application Sponsors

NDA 020839SANOFI AVENTIS US

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 75MG BASE1PLAVIXCLOPIDOGREL BISULFATE
002TABLET;ORALEQ 300MG BASE1PLAVIXCLOPIDOGREL BISULFATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1997-11-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1998-05-21PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1999-08-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2000-01-27PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2000-03-15PRIORITY
LABELING; LabelingSUPPL6AP2000-02-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2000-07-10PRIORITY
LABELING; LabelingSUPPL8AP2000-04-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2000-07-25PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2000-11-09PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2000-10-24PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2001-03-07PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2001-03-07PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2001-06-18PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2001-07-19PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2001-12-05PRIORITY
LABELING; LabelingSUPPL18AP2002-01-28STANDARD
EFFICACY; EfficacySUPPL19AP2002-02-27PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2002-09-10PRIORITY
LABELING; LabelingSUPPL21AP2003-09-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2002-06-10PRIORITY
LABELING; LabelingSUPPL23AP2004-10-13STANDARD
LABELING; LabelingSUPPL24AP2003-09-29STANDARD
LABELING; LabelingSUPPL28AP2005-04-26STANDARD
LABELING; LabelingSUPPL30AP2005-04-25STANDARD
LABELING; LabelingSUPPL31AP2005-04-25STANDARD
LABELING; LabelingSUPPL33AP2005-10-14STANDARD
EFFICACY; EfficacySUPPL34AP2006-08-17PRIORITY
LABELING; LabelingSUPPL35AP2006-08-04STANDARD
LABELING; LabelingSUPPL37AP2007-05-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL38AP2007-09-20N/A
MANUF (CMC); Manufacturing (CMC)SUPPL39AP2007-10-22N/A
LABELING; LabelingSUPPL40AP2009-05-05901 REQUIRED
LABELING; LabelingSUPPL42AP2010-03-12STANDARD
LABELING; LabelingSUPPL44AP2009-11-12UNKNOWN
LABELING; LabelingSUPPL48AP2010-08-24STANDARD
EFFICACY; EfficacySUPPL51AP2011-05-06PRIORITY
REMS; REMSSUPPL52AP2011-02-01N/A
REMS; REMSSUPPL53AP2011-05-03N/A
LABELING; LabelingSUPPL55AP2011-12-20UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL56AP2013-05-24PRIORITY
LABELING; LabelingSUPPL57AP2013-09-12STANDARD
LABELING; LabelingSUPPL58AP2013-12-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL59AP2014-03-12PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL60AP2014-05-14PRIORITY
LABELING; LabelingSUPPL61AP2015-07-16STANDARD
LABELING; LabelingSUPPL62AP2016-09-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL63AP2016-03-24PRIORITY
LABELING; LabelingSUPPL64AP2016-09-16STANDARD
LABELING; LabelingSUPPL67AP2017-07-10STANDARD
LABELING; LabelingSUPPL68AP2017-10-31STANDARD
LABELING; LabelingSUPPL69AP2018-10-11STANDARD
LABELING; LabelingSUPPL70AP2018-05-25STANDARD
LABELING; LabelingSUPPL72AP2019-05-17STANDARD
LABELING; LabelingSUPPL74AP2021-03-01STANDARD
LABELING; LabelingSUPPL78AP2022-09-16STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL7Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL20Null0
SUPPL22Null0
SUPPL42Null6
SUPPL44Null6
SUPPL48Null6
SUPPL51Null7
SUPPL52Null7
SUPPL53Null7
SUPPL55Null7
SUPPL56Null0
SUPPL57Null6
SUPPL58Null6
SUPPL59Null0
SUPPL60Null0
SUPPL61Null6
SUPPL62Null7
SUPPL63Null0
SUPPL64Null15
SUPPL67Null6
SUPPL68Null7
SUPPL69Null7
SUPPL70Null15
SUPPL72Null15
SUPPL74Null7
SUPPL78Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

SANOFI AVENTIS US
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20839
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/020839s072lbl.pdf#page=24"]
            [products] => [{"drugName":"PLAVIX","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"PLAVIX","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/17\/2019","submission":"SUPPL-72","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020839s072lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2018","submission":"SUPPL-69","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020839s069lbl.pdf\"}]","notes":""},{"actionDate":"05\/25\/2018","submission":"SUPPL-70","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020839s070lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2017","submission":"SUPPL-68","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020839s068lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2017","submission":"SUPPL-67","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020839s067lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2017","submission":"SUPPL-67","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020839s067lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2016","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020839s062s064lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2016","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020839s062s064lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/2015","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020839s061lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2013","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020839s058lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2013","submission":"SUPPL-57","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020839s057lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2011","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020839s055lbl.pdf\"}]","notes":""},{"actionDate":"05\/06\/2011","submission":"SUPPL-51","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020839s051lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2011","submission":"SUPPL-52","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020839s052lbl.pdf\"}]","notes":""},{"actionDate":"08\/24\/2010","submission":"SUPPL-48","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020839s048lbl.pdf\"}]","notes":""},{"actionDate":"03\/12\/2010","submission":"SUPPL-42","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020839s042lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2009","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020839s044lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2009","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020839s040lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2007","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020839s038lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2007","submission":"SUPPL-38","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020839s038lbl.pdf\"}]","notes":""},{"actionDate":"05\/01\/2007","submission":"SUPPL-37","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020839s037lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2006","submission":"SUPPL-34","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020839s034lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2006","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020839s035lbl.pdf\"}]","notes":""},{"actionDate":"10\/14\/2005","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020839s033lbl.pdf\"}]","notes":""},{"actionDate":"04\/25\/2005","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020839s030,031lbl.pdf\"}]","notes":""},{"actionDate":"04\/25\/2005","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020839s030,031lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2002","submission":"SUPPL-19","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2002\\\/20-839s019_ClopidogrelPlavix.htm\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PLAVIX","submission":"CLOPIDOGREL BISULFATE","actionType":"EQ 75MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PLAVIX","submission":"CLOPIDOGREL BISULFATE","actionType":"EQ 300MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-05-17
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.