← FDA DRUG APPROVALS

FDA NDA · NDA212614

TRIJARDY XR

empagliflozin, linagliptin, metformin hydrochloride

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA212614
TYPE
NDA
ORIGINAL APPROVAL
2020-01-27
LATEST ACTION
2025-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

TRIJARDY XR · ReferencePrescription
EMPAGLIFLOZIN 25MG, LINAGLIPTIN 5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
TRIJARDY XR · ReferencePrescription
EMPAGLIFLOZIN 10MG, LINAGLIPTIN 5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
TRIJARDY XR · ReferencePrescription
EMPAGLIFLOZIN 12.5MG, LINAGLIPTIN 2.5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
TRIJARDY XR · ReferencePrescription
EMPAGLIFLOZIN 5MG, LINAGLIPTIN 2.5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-10-24Labeling · Supplement 29 · standard — Label ↗AP
2023-10-30Labeling · Supplement 20 · standard — Label ↗AP
2022-10-13Labeling · Supplement 16 · 901 required — Letter ↗AP
2021-06-11Labeling · Supplement 10 · standard — Label ↗AP
2021-06-11Labeling · Supplement 8 · standard — Label ↗AP
2020-10-30Efficacy · Supplement 4 · standard — Letter ↗AP
2020-01-27Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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