FDA.reportPublic FDA data

Application 204513

Type
ANDA
Sponsor
NCM USA BRONX LLC

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
24445-623Sodium Fluoride F 18SODIUM FLUORIDE F 18NCM USA Bronx LLCANDACurrent
24445-623Sodium Fluoride F 18SODIUM FLUORIDE F 18NCM USA Bronx LLCANDACurrent
24445-623Sodium Fluoride F 18SODIUM FLUORIDE F 18NCM USA Bronx LLCANDACurrent
24445-623Sodium Fluoride F 18SODIUM FLUORIDE F 18NCM USA Bronx LLCANDACurrent