NDA 201281

BOEHRINGER INGELHEIM

FDA Drug Application

Application #201281

Documents

• Letter: 2012-09-27
• Letter: 2014-05-23
• Label: 2012-02-01
• Label: 2013-09-09
• Label: 2014-07-31
• Label: 2015-07-30
• Review: 2013-07-26
• Summary Review: 2013-07-26
• Letter: 2012-02-02
• Letter: 2013-06-20
• Letter: 2013-09-10
• Letter: 2014-07-31
• Letter: 2015-07-29
• Letter: 2015-09-01
• Label: 2013-06-25
• Label: 2014-05-28
• Label: 2015-09-03
• Label: 2016-12-27
• Label: 2016-12-27
• Letter: 2016-12-27
• Letter: 2016-12-27
• Letter: 2017-03-20
• Label: 2017-03-21
• Label: 2017-08-11
• Letter: 2017-08-15
• Letter: 2019-07-02
• Letter: 2019-07-05
• Label: 2019-07-08
• Medication Guide: 2019-07-08
• Label: 2019-09-10
• Letter: 2020-03-31
• Label: 2020-03-31
• Medication Guide: 2020-03-31
• Letter: 2022-04-18
• Label: 2022-04-18
• Medication Guide: 2022-04-18

Application Sponsors

NDA 201281

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	2.5MG;500MG	1	JENTADUETO	LINAGLIPTIN; METFORMIN HYDROCHLORIDE
002	TABLET;ORAL	2.5MG;850MG	1	JENTADUETO	LINAGLIPTIN; METFORMIN HYDROCHLORIDE
003	TABLET;ORAL	2.5MG;1GM	1	JENTADUETO	LINAGLIPTIN; METFORMIN HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2012-01-30	STANDARD
LABELING; Labeling	SUPPL	2	AP	2012-09-25	UNKNOWN
LABELING; Labeling	SUPPL	3	AP	2013-06-18	UNKNOWN
EFFICACY; Efficacy	SUPPL	4	AP	2013-09-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2013-12-18	STANDARD
EFFICACY; Efficacy	SUPPL	6	AP	2014-07-30	STANDARD
LABELING; Labeling	SUPPL	7	AP	2014-05-22	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-07-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2015-09-18	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-08-28	901 REQUIRED
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2016-02-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2016-04-29	STANDARD
LABELING; Labeling	SUPPL	14	AP	2016-12-23	901 REQUIRED
LABELING; Labeling	SUPPL	17	AP	2017-03-14	STANDARD
LABELING; Labeling	SUPPL	18	AP	2016-12-23	STANDARD
LABELING; Labeling	SUPPL	19	AP	2017-08-10	STANDARD
EFFICACY; Efficacy	SUPPL	22	AP	2019-07-03	STANDARD
EFFICACY; Efficacy	SUPPL	24	AP	2020-03-30	STANDARD
LABELING; Labeling	SUPPL	25	AP	2019-07-01	901 REQUIRED
LABELING; Labeling	SUPPL	31	AP	2022-04-15	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	4	Null	6
SUPPL	5	Null	0
SUPPL	6	Null	6
SUPPL	7	Null	6
SUPPL	8	Null	7
SUPPL	9	Null	0
SUPPL	10	Null	6
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	7
SUPPL	17	Null	6
SUPPL	18	Null	7
SUPPL	19	Null	7
SUPPL	22	Null	6
SUPPL	24	Null	6
SUPPL	25	Null	6
SUPPL	31	Null	6

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201281
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/201281s024lbl.pdf#page=22"]
            [products] => [{"drugName":"JENTADUETO","activeIngredients":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"2.5MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"JENTADUETO","activeIngredients":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"2.5MG;850MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"JENTADUETO","activeIngredients":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"2.5MG;1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/30\/2020","submission":"SUPPL-24","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201281s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/03\/2019","submission":"SUPPL-22","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201281s022lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2019","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201281s025lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201281s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201281s017lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2016","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201281S014S018lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2016","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201281S014S018lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/201281s010lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/201281s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2014","submission":"SUPPL-6","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201281s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2014","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201281s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/05\/2013","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/201281s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/201281s003lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/201281s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/30\/2012","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\\\/2012\\\/201281s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201281s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/201281_linagliptin_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/201281Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/01\/2019","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201281s025lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"03\/30\/2020","submission":"SUPPL-24","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201281s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"07\/03\/2019","submission":"SUPPL-22","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201281s022lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"08\/10\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201281s019lbl.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-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201281S014S018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/201281Orig1s014,s018ltr.pdf\"}]","notes":">"},{"actionDate":"03\/14\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201281s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/201280Orig1s014,201281Orig1s017,206073Orig1s008,208026Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"12\/23\/2016","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201281S014S018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/201281Orig1s014,s018ltr.pdf\"}]","notes":">"},{"actionDate":"04\/29\/2016","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/11\/2016","submission":"SUPPL-11","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/28\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/201281s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/201280Orig1s012,201281s010,206073Orig1s001ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2015","submission":"SUPPL-9","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/28\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/201281s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/201280Orig1s011,201281Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"05\/22\/2014","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201281s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201280Orig1s009,201281Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"07\/30\/2014","submission":"SUPPL-6","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201281s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201281Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"12\/18\/2013","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/05\/2013","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/201281s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/201281Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"06\/18\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/201281s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/201281Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"09\/25\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201281Orig1s002ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-30
        )

)