Home Applications 761456 Application 761456
Type BLA
Sponsor AMNEAL PHARMS LLC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761456 Boncresa denosumab-mobz 351(k) Interchangeable Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BONCRESA DENOSUMAB-MOBZ INJECTABLE;SUBCUTANEOUS 60MG/ML No No
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Boncresa DENOSUMAB-MOBZ Amneal Pharmaceuticals LLC 29140df2-24a3-4a6f-a8e3-065521448d61 2025-12-22 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761456
Documents# Document, Submission type, Date table Document Submission type Date 84689 ORIG 2026-01-06 84686 ORIG 2026-01-06 84518 ORIG 2025-12-23