General MedicationsORALStandard
VYKAT XR
DIAZOXIDE CHOLINE
Standard Dose
75MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview VYKAT XR is listed in Drugs@FDA under application 216665 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient DIAZOXIDE CHOLINE Form and strength TABLET, EXTENDED RELEASE;ORAL - 75MG Sponsor SOLENO THERAP Submission history Latest submission status date: 2025-03-26 00:00:00.
Structured Monograph
Clinical summary
Approval overview VYKAT XR is listed in Drugs@FDA under application 216665 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient DIAZOXIDE CHOLINE Form and strength TABLET, EXTENDED RELEASE;ORAL - 75MG Sponsor SOLENO THERAP Submission history Latest submission status date: 2025-03-26 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.