Application 761434

Type
BLA
Sponsor
OTSUKA PHARM CO LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VOYXACTSIBEPRENLIMAB-SZSIINJECTABLE;INJECTION400MG/2ML(200MG/ML)NoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84491ORIG 2025-12-22
84330ORIG 2025-11-28
84318ORIG 2025-11-25