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AntidiabeticsSUBCUTANEOUSStandard

SOLIQUA 100/33

INSULIN GLARGINE; LIXISENATIDE

Standard Dose
300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SOLIQUA 100/33 is listed in Drugs@FDA under application 208673 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient INSULIN GLARGINE; LIXISENATIDE Form and strength SOLUTION;SUBCUTANEOUS - 300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML) Sponsor SANOFI-AVENTIS US Submission history Latest submission status date: 2026-03-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview SOLIQUA 100/33 is listed in Drugs@FDA under application 208673 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient INSULIN GLARGINE; LIXISENATIDE Form and strength SOLUTION;SUBCUTANEOUS - 300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML) Sponsor SANOFI-AVENTIS US Submission history Latest submission status date: 2026-03-12 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.