Home Applications 761457 Application 761457
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 761457 Oziltus 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 OZILTUS DENOSUMAB-MOBZ INJECTABLE;SUBCUTANEOUS 120MG/1.7ML (70MG/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 Oziltus DENOSUMAB-MOBZ Amneal Pharmaceuticals LLC f040a245-1be4-4962-a8b7-a13ee7fac707 2025-12-22 Warnings, Adverse reactions Exact identifier application number: BLA761457
Documents# Document, Submission type, Date table Document Submission type Date 84691 ORIG 2026-01-06 84519 ORIG 2025-12-23