Home Applications 761392 Application 761392
Type BLA
Sponsor SAMSUNG BIOEPIS CO LTD Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761392 Ospomyv denosumab-dssb 351(k) Interchangeable Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OSPOMYV DENOSUMAB-DSSB INJECTABLE;SUBCUTANEOUS 60MG/ML No No 002 XBRYK DENOSUMAB-DSSB INJECTABLE;SUBCUTANEOUS 70MG/ML No No 003 DENOSUMAB-DSSB DENOSUMAB-DSSB INJECTABLE;SUBCUTANEOUS 60MG/ML No No 004 DENOSUMAB-DSSB DENOSUMAB-DSSB INJECTABLE;SUBCUTANEOUS 70MG/ML No No
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Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OSPOMYV DENOSUMAB Cordavis Limited e1d80a82-de52-4a34-9df3-609e50667ffb 2025-11-11 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761392
Documents# Document, Submission type, Date table Document Submission type Date 84429 ORIG 2025-12-15 84428 ORIG 2025-12-15 84017 ORIG 2025-10-31 84016 ORIG 2025-10-31 84003 ORIG 2025-10-31 81271 ORIG 2025-02-18 81260 ORIG 2025-02-14 81236 ORIG 2025-02-13