Application 091293

Type
ANDA
Sponsor
SANDOZ

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
66758-055Idarubicin HydrochlorideIdarubicin HydrochlorideSandoz IncANDACurrent