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General MedicationsORALGeneric

QTERN

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

Standard Dose
5MG;EQ 5MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview QTERN is listed in Drugs@FDA under application 209091 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE Form and strength TABLET;ORAL - 5MG;EQ 5MG BASE Sponsor ASTRAZENECA AB Submission history Latest submission status date: 2023-09-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview QTERN is listed in Drugs@FDA under application 209091 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE Form and strength TABLET;ORAL - 5MG;EQ 5MG BASE Sponsor ASTRAZENECA AB Submission history Latest submission status date: 2023-09-12 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Discontinued
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
QTERN (DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE) | Drug Monograph | MedicHelpline