Documents
Application Sponsors
| NDA 206073 | BOEHRINGER INGELHEIM | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 10MG;5MG | 1 | GLYXAMBI | EMPAGLIFLOZIN; LINAGLIPTIN |
| 002 | TABLET;ORAL | 25MG;5MG | 1 | GLYXAMBI | EMPAGLIFLOZIN; LINAGLIPTIN |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2015-01-30 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-12-04 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 6 | AP | 2016-07-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2016-12-23 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2017-03-14 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2016-12-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 11 | AP | 2017-08-10 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2017-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2017-08-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2019-07-03 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2018-10-26 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 2020-03-30 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2019-07-01 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2020-01-24 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 27 | AP | 2021-06-11 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2021-06-11 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2022-03-21 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2022-10-13 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 22 | Null | 15 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 27 | Null | 6 |
| SUPPL | 30 | Null | 7 |
| SUPPL | 31 | Null | 15 |
| SUPPL | 33 | Null | 7 |
CDER Filings
BOEHRINGER INGELHEIM
cder:Array
(
[0] => Array
(
[ApplNo] => 206073
[companyName] => BOEHRINGER INGELHEIM
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/206073s021lbl.pdf#page=33"]
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[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\\\/206073s023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204629Orig1s023,206073Orig1s023,206111Orig1s022,208658Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"07\/01\/2019","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206073s022lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"03\/30\/2020","submission":"SUPPL-21","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label 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site."},{"actionDate":"12\/04\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206073s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206073Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"08\/28\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206073s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/201280Orig1s012,201281s010,206073Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-03-30
)
)