Application 761498

Type
BLA
Sponsor
CELLTRION INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVTOZMATOCILIZUMAB-ANOHINJECTABLE;IV (INFUSION)80MG/4ML(20MG/ML)NoNo
002AVTOZMATOCILIZUMAB-ANOHINJECTABLE;IV (INFUSION)200MG/10ML(20MG/ML)NoNo
003AVTOZMATOCILIZUMAB-ANOHINJECTABLE;IV (INFUSION)400MG/20ML(20MG/ML)NoNo
004AVTOZMATOCILIZUMAB-ANOHINJECTABLE;SUBCUTANEOUS162MG/20ML(20MG/ML)NoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85025ORIG 2026-02-12
84818ORIG 2026-01-22
84793ORIG 2026-01-21
84792ORIG 2026-01-21