Application 216873

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OJJAARAMOMELOTINIB DIHYDROCHLORIDETABLET;ORALEQ 100MG BASEYesNo
002OJJAARAMOMELOTINIB DIHYDROCHLORIDETABLET;ORALEQ 150MG BASEYesNo
003OJJAARAMOMELOTINIB DIHYDROCHLORIDETABLET;ORALEQ 200MG BASEYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85487SUPPL 2026-03-24
85486SUPPL 2026-03-24
85434SUPPL 2026-03-20
85433SUPPL 2026-03-20
82029SUPPL 2025-04-28
82000SUPPL 2025-04-25
75787ORIG 2023-10-17
75502ORIG 2023-09-18
75499ORIG 2023-09-18