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AntidiabeticsINJECTIONStandard

SEMGLEE

INSULIN GLARGINE

Standard Dose
100 UNITS/ML
Max Dose
Refer to approved labeling
Primary Use
This Former NDA Was Deemed To Be a BLA Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SEMGLEE is listed in Drugs@FDA under application 210605 (BLA).

This Former NDA Was Deemed To Be a BLA Review priority: STANDARD Marketing status: Prescription Active ingredient INSULIN GLARGINE Form and strength INJECTABLE;INJECTION - 100 UNITS/ML Sponsor MYLAN PHARMS INC Submission history Latest submission status date: 2020-06-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview SEMGLEE is listed in Drugs@FDA under application 210605 (BLA). This Former NDA Was Deemed To Be a BLA Review priority: STANDARD Marketing status: Prescription Active ingredient INSULIN GLARGINE Form and strength INJECTABLE;INJECTION - 100 UNITS/ML Sponsor MYLAN PHARMS INC Submission history Latest submission status date: 2020-06-11 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.