NUBEQA (DAROLUTAMIDE)
Summary
FDA approved NUBEQA (DAROLUTAMIDE) by BAYER HEALTHCARE. NDA (New Drug) approval (Efficacy) on 2025-06-03. TABLET, ORAL.
Details
Source
Drug Approval
External ID
NDA212099-8
Action Date
2025-06-03
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
NUBEQA (generic: DAROLUTAMIDE), TABLET, ORAL. Application: NDA212099
Company
Context & Analysis
BAYER HEALTHCARE has 3 FDA actions in our database.
Frequently Asked Questions
How often does BAYER HEALTHCARE have FDA actions?
BAYER HEALTHCARE has 3 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 "NDA212099-8" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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