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General MedicationsSUBCUTANEOUSStandard

GVOKE KIT

GLUCAGON

Standard Dose
1MG/0.2ML (1MG/0.2ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview GVOKE KIT is listed in Drugs@FDA under application 212097 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient GLUCAGON Form and strength SOLUTION;SUBCUTANEOUS - 1MG/0.2ML (1MG/0.2ML) Sponsor XERIS Submission history Latest submission status date: 2025-03-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview GVOKE KIT is listed in Drugs@FDA under application 212097 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GLUCAGON Form and strength SOLUTION;SUBCUTANEOUS - 1MG/0.2ML (1MG/0.2ML) Sponsor XERIS Submission history Latest submission status date: 2025-03-14 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.