Details for New Drug Application (NDA): 208169

✉ Email this page to a colleague

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

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Btg Intl	XURIDEN	uridine triacetate	GRANULE;ORAL	208169-001	Sep 4, 2015	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.