Application 761424

Type
BLA
Sponsor
ACCORD BIOPHARMA INC.

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OSVYRTIdenosumab-desuINJECTABLE;SUBCUTANEOUS60MG/MLNoNo
002JUBEREQdenosumab-desuINJECTABLE;SUBCUTANEOUS120MG/1.7MLNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84006ORIG 2025-10-31
83996ORIG 2025-10-31