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General MedicationsORALStandard

TRIJARDY XR

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Standard Dose
12.5MG;2.5MG;1GM
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview TRIJARDY XR is listed in Drugs@FDA under application 212614 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 12.5MG;2.5MG;1GM Sponsor BOEHRINGER INGELHEIM Submission history Latest submission status date: 2025-10-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview TRIJARDY XR is listed in Drugs@FDA under application 212614 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 12.5MG;2.5MG;1GM Sponsor BOEHRINGER INGELHEIM Submission history Latest submission status date: 2025-10-24 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.