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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 205385

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NDA 205385 describes FEBUXOSTAT, which is a drug marketed by Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys, Hikma, Lupin Ltd, Macleods Pharms Ltd, MSN, Pharmobedient, Prinston Inc, Regcon Holdings, Sun Pharm, Sunshine, Torrent, and Zydus Lifesciences, and is included in fifteen NDAs. It is available from twenty-one suppliers. Additional details are available on the FEBUXOSTAT profile page.

The generic ingredient in FEBUXOSTAT is febuxostat. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the febuxostat profile page.

Summary for 205385

Tradename:	FEBUXOSTAT
Applicant:	Pharmobedient
Ingredient:	febuxostat
Patents:	0

Medical Subject Heading (MeSH) Categories for 205385

Gout Suppressants

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Jul 1, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Jul 1, 2019	TE:		RLD:	No

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