FDA.reportPublic FDA data

Application 212299

Type
ANDA
Sponsor
ZYDUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEINJECTABLE, LIPOSOMAL;INJECTION20MG/10ML (2MG/ML)NoNo
002DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEINJECTABLE, LIPOSOMAL;INJECTION50MG/25ML (2MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49315-008DOXORUBICIN HYDROCHLORIDEdoxorubicin hydrochlorideZydus Lifesciences LimitedANDACurrent
49315-008DOXORUBICIN HYDROCHLORIDEdoxorubicin hydrochlorideCadila Healthcare LimitedANDACurrent
49315-009DOXORUBICIN HYDROCHLORIDEdoxorubicin hydrochlorideZydus Lifesciences LimitedANDACurrent
49315-009DOXORUBICIN HYDROCHLORIDEdoxorubicin hydrochlorideCadila Healthcare LimitedANDACurrent
70710-1530DOXORUBICIN HYDROCHLORIDEdoxorubicin hydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1530DOXORUBICIN HYDROCHLORIDEdoxorubicin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1531DOXORUBICIN HYDROCHLORIDEdoxorubicin hydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1531DOXORUBICIN HYDROCHLORIDEdoxorubicin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent