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Last Updated: April 3, 2026

Details for New Drug Application (NDA): 214295

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NDA 214295 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 214295

Tradename:	URSODIOL
Applicant:	Zydus Lifesciences
Ingredient:	ursodiol
Patents:	0

Pharmacology for NDA: 214295

Suppliers and Packaging for NDA: 214295

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
URSODIOL	ursodiol	CAPSULE;ORAL	214295	ANDA	Zydus Pharmaceuticals (USA) Inc.	70710-1483	70710-1483-1	100 CAPSULE in 1 BOTTLE (70710-1483-1)
URSODIOL	ursodiol	CAPSULE;ORAL	214295	ANDA	Zydus Lifesciences Limited	70771-1524	70771-1524-1	100 CAPSULE in 1 BOTTLE (70771-1524-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Oct 16, 2020	TE:	AB	RLD:	No

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