| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 216665 | NDA | SOLENO THERAP | 001 | VYKAT XR | TABLET, EXTENDED RELEASE;ORAL | 25MG | DIAZOXIDE CHOLINE | 2025-03-26 | Prescription | No | |
| 002 | VYKAT XR | TABLET, EXTENDED RELEASE;ORAL | 75MG | DIAZOXIDE CHOLINE | 2025-03-26 | Prescription | No | ||||
| 003 | VYKAT XR | TABLET, EXTENDED RELEASE;ORAL | 150MG | DIAZOXIDE CHOLINE | 2025-03-26 | Prescription | Yes |