FDA.reportPublic FDA data

Application 065275

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDEINJECTABLE;INJECTION1MG/MLNoNo
002IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDESOLUTION;INTRAVENOUS10MG/10ML (1MG/ML)NoNo
003IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDESOLUTION;INTRAVENOUS20MG/20ML (1MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9217Idarubicin HydrochlorideIdarubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9217Idarubicin HydrochlorideIdarubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9218Idarubicin HydrochlorideIdarubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9218Idarubicin HydrochlorideIdarubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9219Idarubicin HydrochlorideIdarubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9219Idarubicin HydrochlorideIdarubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9306Idarubicin HydrochlorideIdarubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9306Idarubicin HydrochlorideIdarubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9307Idarubicin HydrochlorideIdarubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9307Idarubicin HydrochlorideIdarubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9308Idarubicin HydrochlorideIdarubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9308Idarubicin HydrochlorideIdarubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent