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General MedicationsORALStandard

ZITUVIMET XR

METFORMIN HYDROCHLORIDE; SITAGLIPTIN

Standard Dose
500MG;50MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ZITUVIMET XR is listed in Drugs@FDA under application 216778 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient METFORMIN HYDROCHLORIDE; SITAGLIPTIN Form and strength TABLET, EXTENDED RELEASE;ORAL - 500MG;50MG Sponsor ZYDUS LIFESCIENCES Submission history Latest submission status date: 2024-07-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview ZITUVIMET XR is listed in Drugs@FDA under application 216778 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient METFORMIN HYDROCHLORIDE; SITAGLIPTIN Form and strength TABLET, EXTENDED RELEASE;ORAL - 500MG;50MG Sponsor ZYDUS LIFESCIENCES Submission history Latest submission status date: 2024-07-18 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.