Application 219097

Type
NDA
Sponsor
SHORLA ONCOLOGY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMKELDIIMATINIB MESYLATESOLUTION;ORALEQ 80MG BASE/MLYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82126ORIG 2025-05-01
80427ORIG 2024-11-26
80358ORIG 2024-11-25