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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 205443

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NDA 205443 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 205443

Tradename:	FEBUXOSTAT
Applicant:	Zydus Lifesciences
Ingredient:	febuxostat
Patents:	0

Pharmacology for NDA: 205443

Mechanism of Action	Xanthine Oxidase Inhibitors

Medical Subject Heading (MeSH) Categories for 205443

Gout Suppressants

Suppliers and Packaging for NDA: 205443

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FEBUXOSTAT	febuxostat	TABLET;ORAL	205443	ANDA	NuCare Pharmaceuticals, Inc.	68071-3760	68071-3760-9	90 TABLET in 1 BOTTLE (68071-3760-9)
FEBUXOSTAT	febuxostat	TABLET;ORAL	205443	ANDA	Zydus Lifesciences Limited	70771-1552	70771-1552-0	1000 TABLET in 1 BOTTLE (70771-1552-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Jan 9, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Jan 9, 2023	TE:	AB	RLD:	No

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