ASTRAZENECA AB FDA Approval NDA 200678

NDA 200678

ASTRAZENECA AB

FDA Drug Application

Application #200678

Documents

Letter2011-11-21
Letter2016-04-07
Letter2015-09-01
Label2010-11-12
Label2013-06-04
Label2015-09-04
Review2011-09-16
Medication Guide2013-06-12
Letter2010-11-12
Letter2012-03-13
Letter2012-03-13
Letter2012-04-05
Letter2013-05-28
Label2012-03-09
Label2012-03-09
Label2011-11-16
Summary Review2011-09-16
Label2016-09-13
Label2017-01-18
Label2017-01-18
Letter2017-01-24
Letter2017-01-24
Label2017-02-28
Letter2017-03-08
Medication Guide2018-11-08
Letter2019-07-02
Label2019-07-08
Medication Guide2019-07-08

Application Sponsors

NDA 200678ASTRAZENECA AB

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET, EXTENDED RELEASE;ORAL500MG;EQ 5MG BASE1KOMBIGLYZE XRMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL1GM;EQ 5MG BASE1KOMBIGLYZE XRMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORAL1GM;EQ 2.5MG BASE1KOMBIGLYZE XRMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2010-11-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2013-05-15STANDARD
EFFICACY; EfficacySUPPL3AP2012-03-07STANDARD
EFFICACY; EfficacySUPPL4AP2012-03-07STANDARD
LABELING; LabelingSUPPL5AP2011-11-15UNKNOWN
LABELING; LabelingSUPPL7AP2012-04-01UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2012-11-08STANDARD
EFFICACY; EfficacySUPPL10AP2013-05-24STANDARD
EFFICACY; EfficacySUPPL13AP2016-04-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2015-02-09STANDARD
LABELING; LabelingSUPPL16AP2015-08-28901 REQUIRED
EFFICACY; EfficacySUPPL18AP2017-02-27STANDARD
LABELING; LabelingSUPPL19AP2017-01-18901 REQUIRED
LABELING; LabelingSUPPL20AP2017-01-18STANDARD
LABELING; LabelingSUPPL24AP2019-07-01901 REQUIRED

Submissions Property Types

ORIG1Null40
SUPPL2Null0
SUPPL3Null15
SUPPL4Null6
SUPPL5Null7
SUPPL7Null6
SUPPL9Null0
SUPPL10Null6
SUPPL13Null7
SUPPL14Null0
SUPPL16Null7
SUPPL18Null7
SUPPL19Null7
SUPPL20Null15
SUPPL24Null6

CDER Filings

ASTRAZENECA AB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200678
            [companyName] => ASTRAZENECA AB
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/200678s024lbl.pdf#page=47"]
            [products] => [{"drugName":"KOMBIGLYZE XR","activeIngredients":"METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE","strength":"500MG;EQ 5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"KOMBIGLYZE XR","activeIngredients":"METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE","strength":"1GM;EQ 5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"KOMBIGLYZE XR","activeIngredients":"METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE","strength":"1GM;EQ 2.5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/01\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200678s024lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2017","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200678s018lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2017","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200678s019s020lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200678s019s020lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2016","submission":"SUPPL-13","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/200678s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2015","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/200678s016lbledt.pdf\"}]","notes":""},{"actionDate":"05\/24\/2013","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200678s010lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2012","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200678s003s004lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2012","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200678s003s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2011","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200678s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/05\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/200678s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/05\/2010","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/200678s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/200678s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/200678_kombiglyze_xr_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/200678Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/01\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200678s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"01\/18\/2017","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200678s019s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/200678Orig1s019,s020ltr.pdf\"}]","notes":">"},{"actionDate":"01\/18\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200678s019s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/200678Orig1s019,s020ltr.pdf\"}]","notes":">"},{"actionDate":"02\/27\/2017","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200678s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/022350Orig1s018,200678Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"08\/28\/2015","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/200678s016lbledt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/022350Orig1s016,200678Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"02\/09\/2015","submission":"SUPPL-14","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/05\/2016","submission":"SUPPL-13","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/200678s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/022350Orig1s014,200678Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"05\/24\/2013","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200678s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200678Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"11\/08\/2012","submission":"SUPPL-9","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/01\/2012","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200678s007ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"11\/15\/2011","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200678s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/200678s005ltr.pdf\"}]","notes":">"},{"actionDate":"03\/07\/2012","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200678s003s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200678s003,s004ltr.pdf\"}]","notes":">"},{"actionDate":"03\/07\/2012","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200678s003s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200678s003,s004ltr.pdf\"}]","notes":">"},{"actionDate":"05\/15\/2013","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-01
        )

)
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