Details for New Drug Application (NDA): 020675

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NDA 020675 describes URSO FORTE, which is a drug marketed by Abbvie and is included in one NDA. It is available from two suppliers. Additional details are available on the URSO FORTE profile page.

The generic ingredient in URSO FORTE 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 020675

Tradename:	URSO FORTE
Applicant:	Abbvie
Ingredient:	ursodiol
Patents:	0

Pharmacology for NDA: 020675

Suppliers and Packaging for NDA: 020675

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
URSO 250	ursodiol	TABLET;ORAL	020675	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	0591-2998	0591-2998-01	100 TABLET in 1 BOTTLE (0591-2998-01)
URSO 250	ursodiol	TABLET;ORAL	020675	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	0591-3005	0591-3005-01	100 TABLET in 1 BOTTLE (0591-3005-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Dec 10, 1997	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jul 21, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 020675

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	URSO 250	ursodiol	TABLET;ORAL	020675-001	Dec 10, 1997	4,859,660	⤷ Start Trial
Abbvie	URSO FORTE	ursodiol	TABLET;ORAL	020675-002	Jul 21, 2004	4,859,660	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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