FDA.reportPublic FDA data

Application 208759

Type
ANDA
Sponsor
HISUN PHARM HANGZHOU

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAUNORUBICIN HYDROCHLORIDEDAUNORUBICIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 5MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42658-019Daunorubicin Hydrochloridedaunorubicin hydrochlorideHisun Pharmaceuticals USA, Inc.ANDACurrent
42658-019Daunorubicin Hydrochloridedaunorubicin hydrochlorideHisun Pharmaceuticals USA, Inc.ANDACurrent
42658-021Daunorubicin Hydrochloridedaunorubicin hydrochlorideHisun Pharmaceuticals USA, Inc.ANDACurrent
42658-021Daunorubicin Hydrochloridedaunorubicin hydrochlorideHisun Pharmaceuticals USA, Inc.ANDACurrent
42658-021Daunorubicin Hydrochloridedaunorubicin hydrochlorideHisun Pharmaceuticals USA, Inc.ANDACurrent
42658-021Daunorubicin Hydrochloridedaunorubicin hydrochlorideHisun Pharmaceuticals USA, Inc.ANDACurrent