FDA.reportPublic FDA data

Application 203665

Type
ANDA
Sponsor
SOFIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUDEOXYGLUCOSE F18FLUDEOXYGLUCOSE F-18INJECTABLE;INTRAVENOUS20-500mCi/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47584-001FludeoxyglucoseFludeoxyglucose F18Houston Cyclotron Partners LP dba CyclotopeANDACurrent
49609-001FludeoxyglucoseFludeoxyglucose F18SOFIE Co. dba SOFIEANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10242ORIG2013-02-19