FDA.reportPublic FDA data

Application 205871

Type
ANDA
Sponsor
SAGENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FULVESTRANTFULVESTRANTINJECTABLE;INTRAMUSCULAR50MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-462fulvestrantfulvestrantSagent PharmaceuticalsANDACurrent
25021-462fulvestrantfulvestrantSagent PharmaceuticalsANDACurrent
25021-462fulvestrantfulvestrantSagent PharmaceuticalsANDACurrent
25021-462fulvestrantfulvestrantSagent PharmaceuticalsANDACurrent
25021-462fulvestrantfulvestrantSagent PharmaceuticalsANDACurrent
68001-424fulvestrantfulvestrantBluePoint LaboratoriesANDACurrent
68001-424fulvestrantfulvestrantBluePoint LaboratoriesANDACurrent
68001-424fulvestrantfulvestrantBluePoint LaboratoriesANDACurrent
68001-424fulvestrantfulvestrantBluePoint LaboratoriesANDACurrent
68001-424fulvestrantfulvestrantBluePoint LaboratoriesANDACurrent