RecallHawk

BONCRESA (DENOSUMAB-MOBZ)

AMNEAL PHARMS LLC

Summary

FDA approved BONCRESA (DENOSUMAB-MOBZ) by AMNEAL PHARMS LLC. BLA (Biologic) approval on 2025-12-19. INJECTABLE, SUBCUTANEOUS.

Details

Source

Drug Approval

External ID

BLA761456-1

Action Date

2025-12-19

Status

Approved

Category

drug

Product Code

BLA (Biologic)

Product Description

BONCRESA (generic: DENOSUMAB-MOBZ), INJECTABLE, SUBCUTANEOUS. Application: BLA761456

Context & Analysis

AMNEAL PHARMS LLC has 2 FDA actions in our database.

Frequently Asked Questions

How often does AMNEAL PHARMS LLC have FDA actions?

AMNEAL PHARMS LLC has 2 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "BLA761456-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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