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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212614
Company: BOEHRINGER INGELHEIM

Medication Guide

Products on NDA 212614

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	10MG;5MG;1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	12.5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
TRIJARDY XR	EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	25MG;5MG;1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212614

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2020	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212614s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212614Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212614Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2025	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212614s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204629Orig1s063,206111Orig1s046,208658Orig1s034,206073Orig1s044,212614Orig1s029ltr.pdf
10/30/2023	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212614s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206073Orig1s036; 206111Orig1s042; 208658Orig1s028; 212614Orig1s020ltr.pdf
10/13/2022	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212614s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212614Orig1s016ltr.pdf
06/11/2021	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212614s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s028, s029; 206073Orig1s027, s030; 206111Orig1s025, s026; 208658Orig1s013, s015; 212614Orig1s008, s010ltr.pdf
06/11/2021	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212614s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s028, 206073Orig1s027, 206111Orig1s025, 208658Orig1s013, 212614Orig1s008ltr.pdf
10/30/2020	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212614s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212614Orig1s004ltr.pdf

Labels for NDA 212614

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2025	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212614s029lbl.pdf
10/30/2023	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212614s020lbl.pdf
10/13/2022	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212614s016lbl.pdf
06/11/2021	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212614s008s010lbl.pdf
06/11/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212614s008s010lbl.pdf
10/30/2020	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212614s004lbl.pdf
01/27/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212614s000lbl.pdf

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