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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 214849

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NDA 214849 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 214849

Tradename:	URSODIOL
Applicant:	Aurobindo Pharma Ltd
Ingredient:	ursodiol
Patents:	0

Pharmacology for NDA: 214849

Suppliers and Packaging for NDA: 214849

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
URSODIOL	ursodiol	CAPSULE;ORAL	214849	ANDA	Aurobindo Pharma Limited	59651-421	59651-421-01	100 CAPSULE in 1 BOTTLE (59651-421-01)
URSODIOL	ursodiol	CAPSULE;ORAL	214849	ANDA	NorthStar Rx LLC	72603-613	72603-613-01	100 CAPSULE in 1 BOTTLE (72603-613-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Nov 28, 2022	TE:	AB	RLD:	No

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