NDA 212614

BOEHRINGER INGELHEIM

FDA Drug Application

Application #212614

Documents

• Label: 2020-01-28
• Medication Guide: 2020-01-28
• Letter: 2020-01-28
• Review: 2020-10-05
• Letter: 2020-11-03
• Label: 2020-11-03
• Medication Guide: 2020-11-03
• Label: 2021-06-14
• Label: 2021-06-14
• Medication Guide: 2021-06-14
• Letter: 2021-06-15
• Letter: 2021-06-15
• Letter: 2022-10-14
• Label: 2022-10-28
• Medication Guide: 2022-10-28

Application Sponsors

NDA 212614

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	5MG;2.5MG;1GM	1	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	10MG;5MG;1GM	1	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	12.5MG;2.5MG;1GM	1	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	25MG;5MG;1GM	1	TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2020-01-27	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2020-10-30	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-06-11	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-06-11	STANDARD
LABELING; Labeling	SUPPL	16	AP	2022-10-13	901 REQUIRED

Submissions Property Types

ORIG	1	Null	33
SUPPL	4	Null	6
SUPPL	8	Null	6
SUPPL	10	Null	6
SUPPL	16	Null	6

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212614
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/212614s004lbl.pdf#page=43"]
            [products] => [{"drugName":"TRIJARDY XR","activeIngredients":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"5MG;2.5MG;1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"TRIJARDY XR","activeIngredients":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"10MG;5MG;1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"TRIJARDY XR","activeIngredients":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"12.5MG;2.5MG;1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"TRIJARDY XR","activeIngredients":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"25MG;5MG;1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/30\/2020","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212614s004lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212614s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/27\/2020","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\\\/2020\\\/212614s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212614Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/212614Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/30\/2020","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212614s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212614Orig1s004ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-10-30
        )

)