FDA.reportPublic FDA data

Application 203946

Type
ANDA
Sponsor
ESSENTIAL ISOTOPES

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
51760-001Fludeoxyglucose F18Fludeoxyglucose F18Essential Isotopes LLCANDACurrent
51760-001Fludeoxyglucose F18Fludeoxyglucose F18Essential Isotopes LLCANDACurrent
51760-001Fludeoxyglucose F18Fludeoxyglucose F18Essential Isotopes LLCANDACurrent
51760-001Fludeoxyglucose F18Fludeoxyglucose F18Essential Isotopes LLCANDACurrent