FDA.reportPublic FDA data

Application 065289

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDEINJECTABLE;INJECTION50MG/25ML (2MG/ML)NoNo
002EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDEINJECTABLE;INJECTION200MG/100ML (2MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9202Epirubicin HydrochlorideEpirubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9202Epirubicin HydrochlorideEpirubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9203Epirubicin HydrochlorideEpirubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9203Epirubicin HydrochlorideEpirubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent