Application 217677

Type
NDA
Sponsor
SPRINGWORKS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OGSIVEONIROGACESTAT HYDROBROMIDETABLET;ORALEQ 50MG BASEYesNo
002OGSIVEONIROGACESTAT HYDROBROMIDETABLET;ORALEQ 100MG BASEYesNo
003OGSIVEONIROGACESTAT HYDROBROMIDETABLET;ORALEQ 150MG BASEYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85361SUPPL 2026-03-12
85342SUPPL 2026-03-12
78249SUPPL 2024-04-25
78248SUPPL 2024-04-25
77150ORIG 2023-12-27
76669ORIG 2023-12-27
76667ORIG 2023-12-15