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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 202540

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NDA 202540 describes URSODIOL, which is a drug marketed by Abhai Llc, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma, Hibrow Hlthcare, Impax Labs Inc, Lannett Co Inc, Lgm Pharma, Quagen, Rising, Rk Pharma, Strides Pharma, Teva Pharms, Zydus Lifesciences, Epic Pharma Llc, Glenmark Pharms Ltd, Ph Health, and Teva Pharms Usa, and is included in twenty-two NDAs. It is available from twenty-eight suppliers. Additional details are available on the URSODIOL profile page.

The generic ingredient in URSODIOL is ursodiol. There are eight drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ursodiol profile page.

Summary for 202540

Tradename:	URSODIOL
Applicant:	Ph Health
Ingredient:	ursodiol
Patents:	0

Pharmacology for NDA: 202540

Suppliers and Packaging for NDA: 202540

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
URSODIOL	ursodiol	TABLET;ORAL	202540	ANDA	Major Pharmaceuticals	0904-6890	0904-6890-04	30 BLISTER PACK in 1 CARTON (0904-6890-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
URSODIOL	ursodiol	TABLET;ORAL	202540	ANDA	AvKARE	42291-931	42291-931-01	100 TABLET, FILM COATED in 1 BOTTLE (42291-931-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Feb 14, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Feb 14, 2013	TE:	AB	RLD:	No

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