Application 218764

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JASCAYDNERANDOMILASTTABLET;ORAL9MGYesNo
002JASCAYDNERANDOMILASTTABLET;ORAL18MGYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85196SUPPL 2026-03-02
85195SUPPL 2026-03-02
84099ORIG 2025-11-06
83717ORIG 2025-10-10
83688ORIG 2025-10-07