FDA.reportPublic FDA data

Application 065361

Type
ANDA
Sponsor
CIPLA LTD

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
25021-203Epirubicin Hydrochlorideepirubicin hydrochlorideSagent PharmaceuticalsANDACurrent
25021-203Epirubicin Hydrochlorideepirubicin hydrochlorideSagent PharmaceuticalsANDACurrent
59923-701EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDEAreva Pharmaceuticals,Inc.ANDACurrent
59923-701EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDEAreva Pharmaceuticals,Inc.ANDACurrent
59923-701EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDEAreva Pharmaceuticals,Inc.ANDACurrent