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Generated: May 27, 2019

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-six 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
Applicant:Wellstat Therap
Ingredient:uridine triacetate
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 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: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
Patent:➤ Try a Free TrialPatent Expiration:Jul 10, 2023Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

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