FDA.reportPublic FDA data

Application 089556

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDEINJECTABLE;INJECTION2.5MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-281Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-281Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
64725-2810Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDETYA PharmaceuticalsANDACurrent