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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Argus Health
US Army
Covington
Moodys
Daiichi Sankyo
Medtronic
QuintilesIMS
Cantor Fitzgerald

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208169

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NDA 208169 describes XURIDEN, which is a drug marketed by Wellstat Therap and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the XURIDEN profile page.

The generic ingredient in XURIDEN is uridine triacetate. There are thirty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.
Summary for 208169
Tradename:XURIDEN
Applicant:Wellstat Therap
Ingredient:uridine triacetate
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 208169
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 N 69468-152-02
XURIDEN uridine triacetate GRANULE;ORAL 208169 NDA Wellstat Therapeutics Corporation 69468-152 N 69468-152-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength2GM/PACKET
Approval Date:Sep 4, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 4, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Sep 4, 2022
Regulatory Exclusivity Use:TREATMENT OF HEREDITARY OROTIC ACIDURIA
Patent:➤ Sign UpPatent Expiration:Jul 10, 2018Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
McKesson
Moodys
Johnson and Johnson
Express Scripts
UBS
Chinese Patent Office
Dow
Healthtrust

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