General MedicationsORALGeneric

QTERNMET XR

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Standard Dose

10MG;1GM;EQ 5MG BASE

Max Dose

Refer to approved labeling

Primary Use

Review priority: 901 REQUIRED Marketing status: Discontinued

Summary

Approval overview QTERNMET XR is listed in Drugs@FDA under application 210874 (NDA).

Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 10MG;1GM;EQ 5MG BASE Sponsor ASTRAZENECA AB Submission history Latest submission status date: 2020-01-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview QTERNMET XR is listed in Drugs@FDA under application 210874 (NDA). Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 10MG;1GM;EQ 5MG BASE Sponsor ASTRAZENECA AB Submission history Latest submission status date: 2020-01-24 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: 901 REQUIRED

Interaction Notes

No interaction notes stored yet.