General MedicationsORALStandard

ZITUVIMET XR

METFORMIN HYDROCHLORIDE; SITAGLIPTIN

Standard Dose

1GM;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 - 1GM;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 - 1GM;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.