Application 761258

Type
BLA
Sponsor
AKESO BIOPHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENPULIMAB-KCQXPENPULIMAB-KCQXINJECTABLE;INTRAVENOUS100MG/10ML(10MG/ML)NoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82213ORIG 2025-05-21
82095ORIG 2025-05-01
81966ORIG 2025-04-24