Application 216665

Type
NDA
Sponsor
SOLENO THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VYKAT XRDIAZOXIDE CHOLINETABLET, EXTENDED RELEASE;ORAL25MGYesNo
002VYKAT XRDIAZOXIDE CHOLINETABLET, EXTENDED RELEASE;ORAL75MGYesNo
003VYKAT XRDIAZOXIDE CHOLINETABLET, EXTENDED RELEASE;ORAL150MGYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85734ORIG 2026-04-27
81766ORIG 2025-03-28
81760ORIG 2025-03-27
81747ORIG 2025-03-27