Application 200655

Type
NDA
Sponsor
FEINSTEIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUORODOPA F18FLUORODOPA F-18SOLUTION;INTRAVENOUS0.42-8.33mCi/MLYesYes
002FLUORODOPA F18FLUORODOPA F-18SOLUTION;INTRAVENOUS1-40mCi/MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13267-345FluorodopaFluorodopa F18THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCHNDACurrent
13267-346FluorodopaFluorodopa F18THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCHNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81245SUPPL 2020-12-11
81244SUPPL 2020-12-11
60993ORIG2019-11-20
60538ORIG2019-10-11
60537ORIG2019-10-11