Application 761362

Type
BLA
Sponsor
SANDOZ INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001JUBBONTIDENOSUMAB-BBDZINJECTABLE;SUBCUTANEOUS60MG/MLNoNo
002WYOSTDENOSUMAB-BBDZINJECTABLE;SUBCUTANEOUS120MG/1.7ML (70MG/ML)NoNo

Documents

DocumentSubmission typeDate
84019SUPPL 2025-10-31
84018SUPPL 2025-10-31
84002SUPPL 2025-10-31
80016SUPPL 2024-10-28
79987SUPPL 2024-10-25
78914ORIG 2024-06-27
77709ORIG 2024-03-05
77708ORIG 2024-03-05