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General MedicationsTABLET, EXTENDED RELEASEGeneric

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE

Standard Dose
50MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview SITAGLIPTIN AND METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 217017 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE Form and strength TABLET, EXTENDED RELEASE - 50MG Sponsor ZHEJIANG JIUZHOU BIOPHARMA CO., LTD.

Structured Monograph

Clinical summary

Approval overview SITAGLIPTIN AND METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 217017 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE Form and strength TABLET, EXTENDED RELEASE - 50MG Sponsor ZHEJIANG JIUZHOU BIOPHARMA CO., LTD. Submission history Latest submission status date: 2025-11-26 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: None (Tentative Approval)
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE) | Drug Monograph | MedicHelpline