Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsORALGeneric

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

SITAGLIPTIN; METFORMIN HYDROCHLORIDE

Standard Dose
50MG/1000MG
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 215220 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient SITAGLIPTIN; METFORMIN HYDROCHLORIDE Form and strength TABLET; ORAL - 50MG/1000MG Sponsor AJANTA PHARMA LTD Submission history Latest submission status date: 2025-12-31 00:00:00.

Structured Monograph

Clinical summary

Approval overview SITAGLIPTIN AND METFORMIN HYDROCHLORIDE is listed in Drugs@FDA under application 215220 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient SITAGLIPTIN; METFORMIN HYDROCHLORIDE Form and strength TABLET; ORAL - 50MG/1000MG Sponsor AJANTA PHARMA LTD Submission history Latest submission status date: 2025-12-31 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.