FDA.reportPublic FDA data

Application 203912

Type
ANDA
Sponsor
SPECTRON MRC 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
13108-211Sodium Fluoride F 18Sodium Fluoride F 18Spectron mrc, LLCANDACurrent
13108-211Sodium Fluoride F 18Sodium Fluoride F 18NukeMed, Inc. dba SpectronRxANDACurrent