General MedicationsSUBCUTANEOUSStandard
GVOKE HYPOPEN
GLUCAGON
Standard Dose
0.5MG/0.1ML (0.5MG/0.1ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview GVOKE HYPOPEN is listed in Drugs@FDA under application 212097 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient GLUCAGON Form and strength SOLUTION;SUBCUTANEOUS - 0.5MG/0.1ML (0.5MG/0.1ML) Sponsor XERIS Submission history Latest submission status date: 2025-03-14 00:00:00.
Structured Monograph
Clinical summary
Approval overview GVOKE HYPOPEN is listed in Drugs@FDA under application 212097 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GLUCAGON Form and strength SOLUTION;SUBCUTANEOUS - 0.5MG/0.1ML (0.5MG/0.1ML) 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.