FDA.reportPublic FDA data

Application 204264

Type
ANDA
Sponsor
SHERTECH LABS LLC

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
16129-001Fludeoxyglucose F-18Fludeoxyglucose F-18Shertech Laboratories, LLCANDACurrent
16129-001Fludeoxyglucose F-18Fludeoxyglucose F-18Shertech Laboratories, LLCANDACurrent
16129-001Fludeoxyglucose F-18Fludeoxyglucose F-18Shertech Laboratories, LLCANDACurrent
16129-001Fludeoxyglucose F-18Fludeoxyglucose F-18Shertech Laboratories, LLCANDACurrent
16129-001Fludeoxyglucose F-18Fludeoxyglucose F-18Shertech Laboratories, LLCANDACurrent