Details for New Drug Application (NDA): 206266

NDA 206266 describes FEBUXOSTAT, which is a drug marketed by Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys, Hikma, Indoco, Lupin Ltd, Macleods Pharms Ltd, MSN, Mylan, Prinston Inc, Sun Pharm, Sunshine, Torrent, and Zydus Lifesciences, and is included in fifteen NDAs. It is available from twenty-two 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-three suppliers are listed for this compound. Additional details are available on the febuxostat profile page.

Summary for 206266

Tradename:	FEBUXOSTAT
Applicant:	Prinston Inc
Ingredient:	febuxostat
Patents:	0

Pharmacology for NDA: 206266

Mechanism of Action

Xanthine Oxidase Inhibitors

Medical Subject Heading (MeSH) Categories for 206266

Gout Suppressants

Suppliers and Packaging for NDA: 206266

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FEBUXOSTAT	febuxostat	TABLET;ORAL	206266	ANDA	Solco Healthcare US LLC	43547-295	43547-295-03	30 TABLET in 1 BOTTLE (43547-295-03)
FEBUXOSTAT	febuxostat	TABLET;ORAL	206266	ANDA	Solco Healthcare US LLC	43547-295	43547-295-09	90 TABLET in 1 BOTTLE (43547-295-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Mar 28, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Mar 28, 2022	TE:	AB	RLD:	No

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