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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 205789

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NDA 205789 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 205789

Tradename:	URSODIOL
Applicant:	Lgm Pharma
Ingredient:	ursodiol
Patents:	0

Pharmacology for NDA: 205789

Suppliers and Packaging for NDA: 205789

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
URSODIOL	ursodiol	CAPSULE;ORAL	205789	ANDA	FH2 Pharma LLC	72887-143	72887-143-06	60 CAPSULE in 1 BOTTLE (72887-143-06)
URSODIOL	ursodiol	CAPSULE;ORAL	205789	ANDA	FH2 Pharma LLC	72887-144	72887-144-06	60 CAPSULE in 1 BOTTLE (72887-144-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	May 8, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	400MG
Approval Date:	May 8, 2020	TE:		RLD:	No

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