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Last Updated: December 12, 2025

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-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 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	Major Pharmaceuticals	0904-7168	0904-7168-06	50 BLISTER PACK in 1 CARTON (0904-7168-06) / 1 CAPSULE in 1 BLISTER PACK
URSODIOL	ursodiol	CAPSULE;ORAL	211301	ANDA	Major Pharmaceuticals	0904-7168	0904-7168-61	100 BLISTER PACK in 1 CARTON (0904-7168-61) / 1 CAPSULE in 1 BLISTER PACK

Profile for product number 001

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

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