← FDA DRUG APPROVALS

FDA NDA · NDA216665

VYKAT XR

diazoxide choline

Sponsor: SOLENO THERAP

APPLICATION
NDA216665
TYPE
NDA
ORIGINAL APPROVAL
2025-03-26
LATEST ACTION
2025-03-26
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

VYKAT XR · ReferencePrescription
DIAZOXIDE CHOLINE 75MG · TABLET, EXTENDED RELEASE · ORAL
VYKAT XR · ReferencePrescription
DIAZOXIDE CHOLINE 150MG · TABLET, EXTENDED RELEASE · ORAL
VYKAT XR · ReferencePrescription
DIAZOXIDE CHOLINE 25MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-03-26Type 2 - New Active Ingredient · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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