FDA.reportPublic FDA data

Application 203544

Type
ANDA
Sponsor
SOFIE

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47584-002Sodium FluorideSODIUM FLUORIDE F-18Houston Cyclotron Partners LP dba CyclotopeANDACurrent
49609-002Sodium FluorideSODIUM FLUORIDE F-18SOFIE Co. dba SOFIEANDACurrent