FDA.reportPublic FDA data

Application 065445

Type
ANDA
Sponsor
ACTAVIS TOTOWA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDEINJECTABLE;INJECTION10MG/5ML (2MG/ML)NoNo
002EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDEINJECTABLE;INJECTION50MG/25ML (2MG/ML)NoNo
003EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDEINJECTABLE;INJECTION200MG/100ML (2MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1675Epirubicin HydrochlorideEpirubicin HydrochlorideImpax GenericsANDACurrent
45963-608Epirubicin HydrochlorideEpirubicin HydrochlorideActavis Pharma, Inc.ANDACurrent
45963-608Epirubicin HydrochlorideEpirubicin HydrochlorideActavis Pharma, Inc.ANDACurrent
45963-608Epirubicin HydrochlorideEpirubicin HydrochlorideActavis Pharma, Inc.ANDACurrent