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General MedicationsORALGeneric

QTERNMET XR

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Standard Dose
5MG;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 - 5MG;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 - 5MG;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.