BOEHRINGER INGELHEIM FDA Approval NDA 201280

Application #201280

Documents

Letter	2012-08-15
Letter	2012-10-02
Letter	2013-06-20
Letter	2014-05-23
Letter	2015-09-01
Label	2011-05-06
Label	2012-05-23
Label	2012-08-15
Label	2012-10-01
Label	2013-06-25
Label	2015-07-30
Summary Review	2011-06-07
Letter	2011-05-06
Letter	2012-05-24
Letter	2012-08-15
Letter	2015-07-29
Label	2012-08-15
Label	2014-05-28
Label	2015-09-04
Review	2011-06-07
Review	2014-07-07
Letter	2016-12-27
Label	2016-12-30
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 201280

BOEHRINGER INGELHEIM

Marketing Status

Prescription

001

Application Products

001

TABLET;ORAL

5MG

TRADJENTA

LINAGLIPTIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2011-05-02	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2012-05-22	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2012-08-13	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2012-08-13	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2012-09-28	STANDARD
LABELING; Labeling	SUPPL	6	AP	2013-06-18	UNKNOWN
LABELING; Labeling	SUPPL	9	AP	2014-05-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2015-07-20	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-07-28	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-08-28	901 REQUIRED
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2016-12-20	STANDARD
LABELING; Labeling	SUPPL	14	AP	2017-03-14	STANDARD
LABELING; Labeling	SUPPL	15	AP	2016-12-23	STANDARD
LABELING; Labeling	SUPPL	16	AP	2017-08-10	STANDARD
EFFICACY; Efficacy	SUPPL	18	AP	2019-07-03	STANDARD
EFFICACY; Efficacy	SUPPL	20	AP	2020-03-30	STANDARD
LABELING; Labeling	SUPPL	21	AP	2019-07-01	901 REQUIRED
LABELING; Labeling	SUPPL	25	AP	2022-04-15	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	15
SUPPL	3	Null	6
SUPPL	4	Null	6
SUPPL	5	Null	6
SUPPL	6	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	0
SUPPL	11	Null	6
SUPPL	12	Null	6
SUPPL	14	Null	15
SUPPL	15	Null	6
SUPPL	16	Null	7
SUPPL	18	Null	7
SUPPL	20	Null	6
SUPPL	21	Null	6
SUPPL	25	Null	7

TE Codes

001

Prescription

CDER Filings

BOEHRINGER INGELHEIM

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(
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            [companyName] => BOEHRINGER INGELHEIM
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            [products] => [{"drugName":"TRADJENTA","activeIngredients":"LINAGLIPTIN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
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            [supplements] => [{"actionDate":"07\/01\/2019","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201280s021lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"03\/30\/2020","submission":"SUPPL-20","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201280s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"07\/03\/2019","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201280s018lbl.pdf\"},{\"name\":\"Letter 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201280Orig1s003,s004ltr.pdf\"}]","notes":">"},{"actionDate":"05\/22\/2012","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/201280s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201280s002ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/201280Orig1s002.pdf\"}]","notes":">"}]
            [actionDate] => 2020-03-30
        )

)

NDA 201280

BOEHRINGER INGELHEIM

FDA Drug Application

Application #201280

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings

BOEHRINGER INGELHEIM