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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 090801

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NDA 090801 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 090801

Tradename:	URSODIOL
Applicant:	Glenmark Pharms Ltd
Ingredient:	ursodiol
Patents:	0

Pharmacology for NDA: 090801

Suppliers and Packaging for NDA: 090801

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
URSODIOL	ursodiol	TABLET;ORAL	090801	ANDA	BluePoint Laboratories	68001-377	68001-377-00	100 TABLET in 1 BOTTLE (68001-377-00)
URSODIOL	ursodiol	TABLET;ORAL	090801	ANDA	BluePoint Laboratories	68001-378	68001-378-00	100 TABLET in 1 BOTTLE (68001-378-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Jul 12, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jul 12, 2011	TE:	AB	RLD:	No

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