FDA.reportPublic FDA data

Application 019829

Type
NDA
Sponsor
GE HEALTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CERETECTECHNETIUM TC-99M EXAMETAZIME KITINJECTABLE;INJECTIONN/AYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17156-022CERETECTECHNETIUM TC-99M EXAMETAZIMEMedi-Physics Inc. dba GE Healthcare.NDACurrent
17156-023CeretecExametazimeMedi-Physics Inc.NDACurrent
17156-025CeretecTechnetium Tc-99m Exametazime and Cobaltous ChlorideMedi-Physics, Inc. dba GE HealthcareNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55735SUPPL2018-10-01
55535SUPPL2018-09-20
1657SUPPL2013-08-06
33995SUPPL2013-08-05
19270SUPPL2005-06-21