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AntidiabeticsSUBCUTANEOUSStandard

XULTOPHY 100/3.6

INSULIN DEGLUDEC; LIRAGLUTIDE

Standard Dose
300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview XULTOPHY 100/3.6 is listed in Drugs@FDA under application 208583 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient INSULIN DEGLUDEC; LIRAGLUTIDE Form and strength SOLUTION;SUBCUTANEOUS - 300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML) Sponsor NOVO Submission history Latest submission status date: 2025-10-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview XULTOPHY 100/3.6 is listed in Drugs@FDA under application 208583 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient INSULIN DEGLUDEC; LIRAGLUTIDE Form and strength SOLUTION;SUBCUTANEOUS - 300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML) Sponsor NOVO Submission history Latest submission status date: 2025-10-14 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.