General MedicationsORALGeneric

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE

Standard Dose

25MG;5MG;1000MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: None (Tentative Approval)

Summary

Approval overview EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 217049 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 25MG;5MG;1000MG Sponsor ZYDUS PHARMS USA INC Submission history Latest submission status date: 2025-11-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 217049 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 25MG;5MG;1000MG Sponsor ZYDUS PHARMS USA INC Submission history Latest submission status date: 2025-11-25 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: None (Tentative Approval)
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.