FDA.reportPublic FDA data

Application 204542

Type
ANDA
Sponsor
PRECISION NUCLEAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM FLUORIDE F-18SODIUM FLUORIDE F-18INJECTABLE;INTRAVENOUS10-200mCi/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52768-125Sodium FluorideSODIUM FLUORIDE F-18Precision Nuclear LLCANDACurrent
52768-125Sodium FluorideSODIUM FLUORIDE F-18Precision Nuclear LLCANDACurrent
52768-125Sodium FluorideSODIUM FLUORIDE F-18Precision Nuclear LLCANDACurrent