General MedicationsORALGeneric

EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE

Standard Dose

12.5MG; 1GM

Max Dose

Refer to approved labeling

Primary Use

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

Summary

Approval overview EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 213654 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 12.5MG; 1GM Sponsor LUPIN LTD Submission history Latest submission status date: 2021-01-06 00:00:00.

Structured Monograph

Clinical summary

Approval overview EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 213654 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 12.5MG; 1GM Sponsor LUPIN LTD Submission history Latest submission status date: 2021-01-06 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

No interaction notes stored yet.