Documents
Application Sponsors
| NDA 204629 | BOEHRINGER INGELHEIM | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 10MG | 1 | JARDIANCE | EMPAGLIFLOZIN |
| 002 | TABLET;ORAL | 25MG | 1 | JARDIANCE | EMPAGLIFLOZIN |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2014-08-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2015-06-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2015-06-26 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-02-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2016-03-18 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2015-12-04 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2016-12-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2016-01-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2016-01-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2016-04-15 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2016-07-08 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2017-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2018-10-26 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 19 | AP | 2018-12-21 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2020-01-24 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 26 | AP | 2021-08-18 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2021-06-11 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2021-06-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 33 | AP | 2022-02-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 34 | AP | 2022-03-21 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2022-10-13 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 26 | Null | 6 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 33 | Null | 6 |
| SUPPL | 34 | Null | 7 |
| SUPPL | 39 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
BOEHRINGER INGELHEIM
cder:Array
(
[0] => Array
(
[ApplNo] => 204629
[companyName] => BOEHRINGER INGELHEIM
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/204629s023lbl.pdf#page=33"]
[products] => [{"drugName":"JARDIANCE","activeIngredients":"EMPAGLIFLOZIN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"JARDIANCE","activeIngredients":"EMPAGLIFLOZIN","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"01\/24\/2020","submission":"SUPPL-23","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204629s023lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2020","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204629s023lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2018","submission":"SUPPL-19","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204629s019lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204629s018lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204629s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204629s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204629s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2016","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204629s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/18\/2016","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204629s005lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204629s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204629s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2015","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204629s001s002s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2015","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204629s001s002s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2015","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204629s001s002s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204629s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"08\/01\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204629s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204629Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204629Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204629Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"01\/24\/2020","submission":"SUPPL-23","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204629s023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204629Orig1s023,206073Orig1s023,206111Orig1s022,208658Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"12\/21\/2018","submission":"SUPPL-19","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204629s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204629Orig1s019Ltr.pdf\"}]","notes":">"},{"actionDate":"10\/26\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204629s018lbl.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-16","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204629s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204629Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"07\/08\/2016","submission":"SUPPL-12","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204629Orig1s012ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/15\/2016","submission":"SUPPL-11","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/21\/2016","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/12\/2016","submission":"SUPPL-9","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/02\/2016","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204629s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204629Orig1s008ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/204629Orig1s008.pdf\"}]","notes":">"},{"actionDate":"12\/04\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204629s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204629Orig1s007ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/204629Orig1s007.pdf\"}]","notes":">"},{"actionDate":"03\/18\/2016","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204629s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204629Orig1s005ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/204629Orig1s005.pdf\"}]","notes":">"},{"actionDate":"02\/05\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204629s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204629Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"06\/26\/2015","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204629s001s002s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204629Orig1s001,s002,s003ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/204629Orig1s003.pdf\"}]","notes":">"},{"actionDate":"06\/26\/2015","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204629s001s002s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204629Orig1s001,s002,s003ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/204629Orig1s002.pdf\"}]","notes":">"},{"actionDate":"06\/26\/2015","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204629s001s002s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204629Orig1s001,s002,s003ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/204629Orig1s001.pdf\"}]","notes":">"}]
[actionDate] => 2020-01-24
)
)