Application 208159

Type
NDA
Sponsor
WELLSTAT THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VISTOGARDURIDINE TRIACETATEGRANULE;ORAL10GM/PACKETYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69468-151VISTOGARDuridine triacetateWellstat Therapeutics CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
46068ORIG2016-09-30
40620SUPPL2016-03-31
10646SUPPL2016-03-31
10645ORIG2015-12-14
40619ORIG2015-12-11