uridine triacetate Oral Granules

Brand(s)
Xuriden
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Wellstat Therapeutics Corporation (2015-09-14)
Oldest Current Product
2015-09-08
License(s)
NDA
RxNORM
ORAL GRANULES\URIDINE TRIACETATE
FDAOB
ORAL\GRANULE\URIDINE TRIACETATE
SPL Active
ORAL\GRANULE\URIDINE TRIACETATE
SPL Moiety
ORAL\GRANULE\URIDINE TRIACETATE

product(s) by strength(s)

uridine triacetate 2000 mg oral granules

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1694680152XuridenNDAWellstat Therapeutics Corporation2015-09-08URIDINE TRIACETATEORALGRANULENDA20816940606ca9-4f14-45b7-8632-fc2d17d11a2e

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA208169XURIDENWELLSTAT THERAPEUTICS CORP2015-09-04p6258795, SUBSTANCENEW CHEMICAL ENTITY [2020-09-04]
ORPHAN DRUG EXCLUSIVITY [2022-09-04]
NDA208169_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA208169_001RXURIDINE TRIACETATE (2GM/PACKET)ORALGRANULETrue2015-09-04XURIDEN

patent(s)

#idexpiration dateapplication(s)
1p6258795 (view patent)2018-07-10NDA208169

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
140606ca9-4f14-45b7-8632-fc2d17d11a2e (view SPL)These highlights do not include all the information needed to use XURIDEN safely and effectively. See full prescribing information for XURIDEN. XURIDEN (uridine triacetate) oral granules Initial U.S. Approval: 2015prescriptionHuman PrescriptionWellstat Therapeutics CorporationANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-09-142694680152

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII