FDA.reportPublic FDA data

Application 203591

Type
ANDA
Sponsor
SOFIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUDEOXYGLUCOSE F18FLUDEOXYGLUCOSE F-18INJECTABLE;INTRAVENOUS20-300mCi/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49609-101Fludeoxyglucose F 18Fludeoxyglucose F-18SOFIE Co.ANDACurrent
49609-101Fludeoxyglucose F 18Fludeoxyglucose F-18SOFIE Co.ANDACurrent
49609-101Fludeoxyglucose F 18Fludeoxyglucose F-18SOFIE Co.ANDACurrent