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Drug profile · INN

darolutamide

NUBEQA

FDA: approved EMA: approved TGA: approved PMDA: approved L02BB
US status
approved
Patents linked
0
News articles
0

Quick answer

darolutamide (NUBEQA) is an FDA-listed pharmaceutical active ingredient. Associated with Bayer Australia Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN darolutamide
Brand NUBEQA
Route ORAL
Formulation TABLET
ATC code L02BB
Originator Bayer Australia Ltd

Frequently asked questions

What is darolutamide?

darolutamide (NUBEQA) is an FDA-listed pharmaceutical active ingredient. Associated with Bayer Australia Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for darolutamide?

NUBEQA is a marketed brand name for darolutamide. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of darolutamide?

darolutamide has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.