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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 NDA: 208169

Wellstat Therap
uridine triacetate
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 208169

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength2GM/PACKET
Approval Date:Sep 4, 2015TE:RLD:Yes
Patent:6,258,795Patent Expiration:Jul 10, 2018Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Sep 4, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Sep 4, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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