Application 219301

Type
NDA
Sponsor
KALVISTA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EKTERLYSEBETRALSTATTABLET;ORAL300MGYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83059ORIG 2025-08-07
82746ORIG 2025-07-08
82745ORIG 2025-07-08