Application 220358

Type
NDA
Sponsor
VANDA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BYSANTIMILSAPERIDONETABLET;ORAL1MGYesYes
002BYSANTIMILSAPERIDONETABLET;ORAL2MGYesNo
003BYSANTIMILSAPERIDONETABLET;ORAL4MGYesNo
004BYSANTIMILSAPERIDONETABLET;ORAL6MGYesNo
005BYSANTIMILSAPERIDONETABLET;ORAL8MGYesNo
006BYSANTIMILSAPERIDONETABLET;ORAL10MGYesNo
007BYSANTIMILSAPERIDONETABLET;ORAL12MGYesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85314ORIG 2026-03-10
85313ORIG 2026-03-10
85157ORIG 2026-02-25
85114ORIG 2026-02-24