Details for New Drug Application (NDA): 208169

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NDA 208169 describes XURIDEN, which is a drug marketed by Btg Intl and is included in one NDA. It is available from one supplier. Additional details are available on the XURIDEN profile page.

The generic ingredient in XURIDEN is uridine triacetate. There are thirty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the uridine triacetate profile page.

Summary for 208169

Tradename:	XURIDEN
Applicant:	Btg Intl
Ingredient:	uridine triacetate
Patents:	0

Pharmacology for NDA: 208169

Ingredient-type	Analogs/Derivatives Pyrimidines

Suppliers and Packaging for NDA: 208169

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XURIDEN	uridine triacetate	GRANULE;ORAL	208169	NDA	Wellstat Therapeutics Corporation	69468-152	69468-152-02	2 g in 1 PACKET (69468-152-02)
XURIDEN	uridine triacetate	GRANULE;ORAL	208169	NDA	Wellstat Therapeutics Corporation	69468-152	69468-152-30	30 PACKET in 1 CARTON (69468-152-30) / 2 g in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GRANULE;ORAL			Strength	2GM/PACKET
Approval Date:	Sep 4, 2015	TE:		RLD:	Yes

Expired US Patents for NDA 208169

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Btg Intl	XURIDEN	uridine triacetate	GRANULE;ORAL	208169-001	Sep 4, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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