BOEHRINGER INGELHEIM FDA Approval NDA 208658

NDA 208658

BOEHRINGER INGELHEIM

FDA Drug Application

Application #208658

Documents

Letter2016-12-13
Label2016-12-15
Label2016-12-27
Letter2016-12-27
Review2017-10-26
Label2017-12-14
Medication Guide2017-12-14
Letter2017-12-15
Label2018-10-29
Medication Guide2018-10-29
Letter2018-10-30
Label2020-01-27
Medication Guide2020-01-27
Letter2020-01-27
Label2021-06-14
Label2021-06-14
Letter2021-06-14
Letter2021-06-14
Medication Guide2021-06-14
Letter2022-03-22
Label2022-03-28
Medication Guide2022-03-28
Letter2022-10-14
Label2022-10-17
Medication Guide2022-10-17

Application Sponsors

NDA 208658BOEHRINGER INGELHEIM

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET, EXTENDED RELEASE;ORAL5MG;1GM1SYNJARDY XREMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL10MG;1GM1SYNJARDY XREMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORAL12.5MG;1GM1SYNJARDY XREMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
004TABLET, EXTENDED RELEASE;ORAL25MG;1GM1SYNJARDY XREMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2016-12-09STANDARD
LABELING; LabelingSUPPL4AP2017-12-13STANDARD
LABELING; LabelingSUPPL6AP2018-10-26901 REQUIRED
LABELING; LabelingSUPPL9AP2020-01-24901 REQUIRED
LABELING; LabelingSUPPL13AP2021-06-11STANDARD
LABELING; LabelingSUPPL15AP2021-06-11STANDARD
LABELING; LabelingSUPPL17AP2022-03-21STANDARD
LABELING; LabelingSUPPL23AP2022-10-13901 REQUIRED

Submissions Property Types

ORIG1Null15
SUPPL4Null7
SUPPL6Null7
SUPPL9Null6
SUPPL13Null15
SUPPL15Null15
SUPPL17Null7
SUPPL23Null6

CDER Filings

BOEHRINGER INGELHEIM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208658
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/208658s009lbl.pdf#page=39"]
            [products] => [{"drugName":"SYNJARDY XR","activeIngredients":"EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"5MG;1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SYNJARDY XR","activeIngredients":"EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"10MG;1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SYNJARDY XR","activeIngredients":"EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"12.5MG;1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SYNJARDY XR","activeIngredients":"EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"25MG;1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/24\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208658s009lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208658s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208658s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208658s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208658s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2016","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208658s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/09\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208658s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/09\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208658s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208658Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208658Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/24\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208658s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204629Orig1s023,206073Orig1s023,206111Orig1s022,208658Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"10\/26\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208658s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204629Orig1s018,206073Orig1s019,206111Orig1s018,208658Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"12\/13\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208658s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206111Orig1s015,208658Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"12\/23\/2016","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208658s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208658Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-01-24
        )

)
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