Documents
Application Sponsors
| NDA 206111 | BOEHRINGER INGELHEIM | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | TABLET;ORAL | 5MG;500MG | 1 | SYNJARDY | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
| 002 | TABLET;ORAL | 5MG;1GM | 1 | SYNJARDY | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
| 003 | TABLET;ORAL | 12.5MG;500MG | 1 | SYNJARDY | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
| 004 | TABLET;ORAL | 12.5MG;1GM | 1 | SYNJARDY | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2015-08-26 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2015-12-04 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2016-12-23 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2016-07-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2016-05-06 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2016-07-08 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 15 | AP | 2017-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2018-10-26 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 22 | AP | 2020-01-24 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 25 | AP | 2021-06-11 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2021-06-11 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2022-03-21 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2022-10-13 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 15 | Null | 15 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 22 | Null | 7 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 26 | Null | 7 |
| SUPPL | 31 | Null | 7 |
| SUPPL | 36 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
BOEHRINGER INGELHEIM
cder:Array
(
[0] => Array
(
[ApplNo] => 206111
[companyName] => BOEHRINGER INGELHEIM
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/206111s018lbl.pdf#page=39"]
[products] => [{"drugName":"SYNJARDY","activeIngredients":"EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"5MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SYNJARDY","activeIngredients":"EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"5MG;1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SYNJARDY","activeIngredients":"EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"12.5MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SYNJARDY","activeIngredients":"EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE","strength":"12.5MG;1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"01\/24\/2020","submission":"SUPPL-22","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206111s022lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2020","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206111s022lbl.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\\\/206111s018lbl.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\\\/206111s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2017","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206111s015lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2016","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206111s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206111s009lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206111s009lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206111s009lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206111s009lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2016","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206111s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206111s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206111lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"08\/26\/2015","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\\\/2015\\\/206111lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206111Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206111Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"01\/24\/2020","submission":"SUPPL-22","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206111s022lbl.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-18","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206111s018lbl.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-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206111s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206111Orig1s015,208658Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"07\/08\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206111s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206111Orig1s001,s006,s009ltr.pdf\"}]","notes":">"},{"actionDate":"05\/06\/2016","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/08\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206111s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206111Orig1s001,s006,s009ltr.pdf\"}]","notes":">"},{"actionDate":"12\/23\/2016","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206111s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206111Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"12\/04\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206111s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206111Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"07\/08\/2016","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206111s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206111Orig1s001,s006,s009ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-01-24
)
)