SANOFI AVENTIS US FDA Approval NDA 020496

NDA 020496

SANOFI AVENTIS US

FDA Drug Application

Application #020496

Documents

Letter1999-02-24
Letter2002-04-15
Letter2005-09-22
Letter2009-02-13
Label2009-02-04
Label2013-08-09
Label2013-10-22
Review1999-02-24
Review2004-05-27
Letter2004-08-25
Letter2005-12-06
Letter2009-02-13
Letter2009-06-16
Letter2012-02-08
Letter2013-08-05
Letter2013-10-18
Label2005-12-05
Label2005-09-22
Label2009-02-04
Label2009-06-04
Label2012-02-06
Letter2016-12-22
Label2016-12-21
Pediatric Medical Review1900-01-01
Pediatric Written Request1900-01-01
Pediatric Statistical Review1900-01-01
Label2018-12-26
Letter2018-12-31
Review2019-02-15

Application Sponsors

NDA 020496SANOFI AVENTIS US

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL1MG1AMARYLGLIMEPIRIDE
002TABLET;ORAL2MG1AMARYLGLIMEPIRIDE
003TABLET;ORAL4MG1AMARYLGLIMEPIRIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1995-11-30STANDARD
EFFICACY; EfficacySUPPL2AP1999-02-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1998-09-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1998-09-16STANDARD
EFFICACY; EfficacySUPPL5AP2000-09-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2000-01-06STANDARD
LABELING; LabelingSUPPL7AP2002-04-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2000-08-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2000-12-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2001-07-21STANDARD
LABELING; LabelingSUPPL13AP2004-08-16STANDARD
EFFICACY; EfficacySUPPL15AP2005-11-28PRIORITY
LABELING; LabelingSUPPL16AP2005-09-19STANDARD
LABELING; LabelingSUPPL18AP2009-02-03STANDARD
LABELING; LabelingSUPPL19AP2009-02-03STANDARD
LABELING; LabelingSUPPL21AP2009-06-04STANDARD
LABELING; LabelingSUPPL22AP2012-02-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2013-03-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2013-04-19STANDARD
LABELING; LabelingSUPPL26AP2013-08-01STANDARD
LABELING; LabelingSUPPL27AP2013-10-15STANDARD
LABELING; LabelingSUPPL28AP2016-12-19STANDARD
LABELING; LabelingSUPPL29AP2018-12-21STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL4Null0
SUPPL6Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL15Null6
SUPPL22Null7
SUPPL24Null0
SUPPL25Null0
SUPPL26Null15
SUPPL27Null6
SUPPL28Null6
SUPPL29Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

SANOFI AVENTIS US
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20496
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMARYL","activeIngredients":"GLIMEPIRIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"AMARYL","activeIngredients":"GLIMEPIRIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"AMARYL","activeIngredients":"GLIMEPIRIDE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/21\/2018","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020496s029lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2016","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020496s028lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2013","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020496s027lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2013","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020496s026lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2012","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020496s022lbl.pdf\"}]","notes":""},{"actionDate":"06\/04\/2009","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020496s021lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2009","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020496s018s019lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2009","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020496s018s019lbl.pdf\"}]","notes":""},{"actionDate":"11\/28\/2005","submission":"SUPPL-15","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020496s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2005","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020496s016lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"AMARYL","submission":"GLIMEPIRIDE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AMARYL","submission":"GLIMEPIRIDE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AMARYL","submission":"GLIMEPIRIDE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-21
        )

)
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