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Generated: November 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208159

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NDA 208159 describes VISTOGARD, which is a drug marketed by Wellstat Therap and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the VISTOGARD profile page.

The generic ingredient in VISTOGARD 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 208159
Tradename:VISTOGARD
Applicant:Wellstat Therap
Ingredient:uridine triacetate
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 208159
Suppliers and Packaging for NDA: 208159
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VISTOGARD uridine triacetate GRANULE;ORAL 208159 NDA Wellstat Therapeutics Corporation 69468-151 69468-151-04 4 PACKET in 1 CARTON (69468-151-04) > 10 g in 1 PACKET (69468-151-10)
VISTOGARD uridine triacetate GRANULE;ORAL 208159 NDA Wellstat Therapeutics Corporation 69468-151 69468-151-10 10 g in 1 PACKET (69468-151-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength10GM/PACKET
Approval Date:Dec 11, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 11, 2022
Regulatory Exclusivity Use:EMERGENCY TX OF PTS FOLLOWING A FU OR CAPECITABINE OD, OR WHO EXHIBIT EARLY-ONSET, SEVERE OR LIFE-THREATENING TOXICITY AFFECTING THE CARDIAC SYSTEM OR CNS, AND/OR EARLY-ONSET, UNUSUALLY SEVERE AR W/IN 96 HRS FOLLOWING THE END OF FU OR CAPECITABINE ADMIN.
Regulatory Exclusivity Expiration:Sep 4, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Dec 11, 2018
Regulatory Exclusivity Use:NEW PRODUCT

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