Details for New Drug Application (NDA): 213504

NDA 213504 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, Norvium Bioscience, Rising, Rk Pharma, Strides Pharma, Teva Pharms, Zydus Lifesciences, Endo Operations, Epic Pharma Llc, Glenmark Pharms Ltd, 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 213504

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

Pharmacology for NDA: 213504

Suppliers and Packaging for NDA: 213504

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
URSODIOL	ursodiol	TABLET;ORAL	213504	ANDA	Strides Pharma Science Limited	64380-918	64380-918-06	100 TABLET in 1 BOTTLE (64380-918-06)
URSODIOL	ursodiol	TABLET;ORAL	213504	ANDA	Strides Pharma Science Limited	64380-919	64380-919-06	100 TABLET in 1 BOTTLE (64380-919-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Aug 20, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Aug 20, 2020	TE:	AB	RLD:	No

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