FDA.reportPublic FDA data

Application 204541

Type
ANDA
Sponsor
ESSENTIAL ISOTOPES

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
51760-002Sodium FluorideSODIUM FLUORIDE F-18Essential Isotopes LLCANDACurrent
51760-002Sodium FluorideSODIUM FLUORIDE F-18Essential Isotopes LLCANDACurrent
51760-002Sodium FluorideSODIUM FLUORIDE F-18Essential Isotopes LLCANDACurrent
51760-002Sodium FluorideSODIUM FLUORIDE F-18Essential Isotopes LLCANDACurrent