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General MedicationsORALStandard

INPEFA

SOTAGLIFLOZIN

Standard Dose
400MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview INPEFA is listed in Drugs@FDA under application 216203 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SOTAGLIFLOZIN Form and strength TABLET;ORAL - 400MG Sponsor LEXICON PHARMS INC Submission history Latest submission status date: 2023-05-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview INPEFA is listed in Drugs@FDA under application 216203 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SOTAGLIFLOZIN Form and strength TABLET;ORAL - 400MG Sponsor LEXICON PHARMS INC Submission history Latest submission status date: 2023-05-26 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.