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General MedicationsORALStandard

XIGDUO XR

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Standard Dose
5MG;1GM
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview XIGDUO XR is listed in Drugs@FDA under application 205649 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 5MG;1GM Sponsor ASTRAZENECA AB Submission history Latest submission status date: 2024-12-20 00:00:00.

Structured Monograph

Clinical summary

Approval overview XIGDUO XR is listed in Drugs@FDA under application 205649 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 5MG;1GM Sponsor ASTRAZENECA AB Submission history Latest submission status date: 2024-12-20 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
XIGDUO XR (DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE) | Drug Monograph | MedicHelpline