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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 211301

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NDA 211301 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 211301

Tradename:	URSODIOL
Applicant:	Amneal Pharms Co
Ingredient:	ursodiol
Patents:	0

Pharmacology for NDA: 211301

Suppliers and Packaging for NDA: 211301

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
URSODIOL	ursodiol	CAPSULE;ORAL	211301	ANDA	AvPAK	50268-797	50268-797-15	50 BLISTER PACK in 1 BOX (50268-797-15) / 1 CAPSULE in 1 BLISTER PACK (50268-797-11)
URSODIOL	ursodiol	CAPSULE;ORAL	211301	ANDA	Amneal Pharmaceuticals NY LLC	69238-1540	69238-1540-1	100 CAPSULE in 1 BOTTLE (69238-1540-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Oct 16, 2018	TE:		RLD:	No

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