Application 219379

Type
NDA
Sponsor
SPRINGWORKS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GOMEKLIMIRDAMETINIBTABLET, FOR SUSPENSION;ORAL1MGYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81692ORIG 2025-03-24
81691ORIG 2025-03-24
81220ORIG 2025-02-12
81218ORIG 2025-02-12