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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 210344

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NDA 210344 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-seven 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the ursodiol profile page.

Summary for 210344

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

Pharmacology for NDA: 210344

Suppliers and Packaging for NDA: 210344

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
URSODIOL	ursodiol	CAPSULE;ORAL	210344	ANDA	Golden State Medical Supply, Inc.	51407-754	51407-754-01	100 CAPSULE in 1 BOTTLE (51407-754-01)
URSODIOL	ursodiol	CAPSULE;ORAL	210344	ANDA	Strides Pharma Science Limited	64380-844	64380-844-04	30 CAPSULE in 1 BOTTLE (64380-844-04)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Jan 22, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Jan 16, 2026	TE:		RLD:	No

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