An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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
10/30/2023	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

Top