FDA.reportPublic FDA data

Application 018511

Type
NDA
Sponsor
JUBILANT DRAXIMAGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DRAXIMAGE DTPATECHNETIUM TC-99M PENTETATE KITINJECTABLE;INJECTIONN/AYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65174-288DRAXIMAGE DTPAKit for the preparation of Technetium Tc 99m PentetateJubilant DraxImage Inc.NDACurrent
65174-288DRAXIMAGE DTPAKit for the preparation of Technetium Tc 99m PentetateJubilant DraxImage Inc., dba Jubilant RadiopharmaNDACurrent
65174-288DRAXIMAGE DTPAKit for the preparation of Technetium Tc 99m PentetateJubilant DraxImage Inc., dba Jubilant RadiopharmaNDACurrent
65174-288DRAXIMAGE DTPAKit for the preparation of Technetium Tc 99m PentetateJubilant DraxImage Inc., dba Jubilant RadiopharmaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74461SUPPL 2023-06-08
74460SUPPL 2023-06-08
72402SUPPL2022-10-17
72310SUPPL2022-10-12
51022SUPPL2018-01-10
50977SUPPL2017-12-29
50938SUPPL2017-12-28
33501SUPPL2011-09-29
937SUPPL2011-09-28
54162SUPPL1900-01-01
54161SUPPL1900-01-01