Application 761457

Type
BLA
Sponsor
AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OZILTUSDENOSUMAB-MOBZINJECTABLE;SUBCUTANEOUS120MG/1.7ML (70MG/ML)NoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84691ORIG 2026-01-06
84519ORIG 2025-12-23