FDA.reportPublic FDA data

Application 204464

Type
ANDA
Sponsor
DECATUR

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
69126-002Sodium Fluoride F 18Sodium Fluoride F 18Global Isotopes, LLC d/b/a Zevacor MolecularANDACurrent
73410-002Sodium Fluoride F 18Sodium Fluoride F 18Decatur Memorial HospitalANDACurrent