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General MedicationsTABLET, EXTENDED RELEASEGeneric

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, SITAGLIPTIN

Standard Dose
EQ 100MG BASE TABLET
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 219296 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient METFORMIN HYDROCHLORIDE, SITAGLIPTIN Form and strength TABLET, EXTENDED RELEASE - EQ 100MG BASE TABLET Sponsor FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO., Submission history Latest submission status date: 2025-08-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview SITAGLIPTIN AND METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 219296 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient METFORMIN HYDROCHLORIDE, SITAGLIPTIN Form and strength TABLET, EXTENDED RELEASE - EQ 100MG BASE TABLET Sponsor FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO., Submission history Latest submission status date: 2025-08-12 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.