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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 three patents protecting this drug. Additional details are available on the VISTOGARD profile page.

The generic ingredient in VISTOGARD 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: 208159

Tradename:
VISTOGARD
Applicant:
Wellstat Therap
Ingredient:
uridine triacetate
Patents:3
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength10GM/PACKET
Approval Date:Dec 11, 2015TE:RLD:Yes
Patent:6,258,795Patent Expiration:Jul 10, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:5,968,914Patent Expiration:Oct 19, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:EMERGENCY TREATMENT OF ADULT & PEDIATRIC PATIENTS FOLLOWING FLUOROURACIL OR CAPECITABINE OVERDOSE,OR WHO EXHIBIT EARLY-ONSET,SEVERE OR LIFE-THREATENING CARDIAC OR CNS TOXICITY OR UNUSUALLY SEVERE ADVERSE REACTIONS WITHIN 96 HOURS
Patent:7,776,838Patent Expiration:Aug 17, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:EMERGENCY TREATMENT OF ADULT & PEDIATRIC PATIENTS FOLLOWING FLUOROURACIL OR CAPECITABINE OVERDOSE,OR WHO EXHIBIT EARLY-ONSET,SEVERE OR LIFE-THREATENING CARDIAC OR CNS TOXICITY OR UNUSUALLY SEVERE ADVERSE REACTIONS WITHIN 96 HOURS

Expired Orange Book Patents for NDA: 208159

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wellstat Therap
VISTOGARD
uridine triacetate
GRANULE;ORAL208159-001Dec 11, 20155,968,914► subscribe
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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 verifification 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.

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