Documents
Application Sponsors
| NDA 208026 | BOEHRINGER INGELHEIM | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 2.5MG;1GM | 1 | JENTADUETO XR | LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 5MG;1GM | 1 | JENTADUETO XR | LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2016-05-27 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2017-03-14 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-12-23 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2017-08-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2019-07-03 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2020-03-30 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2019-07-01 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 20 | AP | 2021-10-01 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 20 | Null | 6 |
CDER Filings
BOEHRINGER INGELHEIM
cder:Array
(
[0] => Array
(
[ApplNo] => 208026
[companyName] => BOEHRINGER INGELHEIM
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/208026s012lbl.pdf#page=22"]
[products] => [{"drugName":"JENTADUETO XR","activeIngredients":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"2.5MG;1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"JENTADUETO XR","activeIngredients":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"5MG;1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/30\/2020","submission":"SUPPL-12","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208026s012lbl.pdf\"}]","notes":""},{"actionDate":"07\/03\/2019","submission":"SUPPL-8","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208026s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208026s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208026s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208026s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208026s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/27\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208026s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"05\/27\/2016","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\\\/2016\\\/208026s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208026Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208026Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208026Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"07\/01\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208026s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"03\/30\/2020","submission":"SUPPL-12","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208026s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"07\/03\/2019","submission":"SUPPL-8","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208026s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"08\/10\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208026s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/201280Orig1s016,201281Orig1s019,208026Orig1s005,206073Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"12\/23\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208026s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/201280Orig1s015,208026Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"03\/14\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208026s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/201280Orig1s014,201281Orig1s017,206073Orig1s008,208026Orig1s003ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-03-30
)
)