FDA.reportPublic FDA data

Application 203622

Type
ANDA
Sponsor
ACTAVIS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEINJECTABLE;INJECTION2MG/MLNoNo
002DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEINJECTABLE;INJECTION200MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-001Doxorubicin hydrochlorideDoxorubicin hydrochlorideNorthstar RxLLCANDACurrent
16714-001Doxorubicin hydrochlorideDoxorubicin hydrochlorideNorthstar RxLLCANDACurrent
16714-001Doxorubicin hydrochlorideDoxorubicin hydrochlorideNorthstar RxLLCANDACurrent
16714-001Doxorubicin hydrochlorideDoxorubicin hydrochlorideNorthstar RxLLCANDACurrent
45963-733Doxorubicin hydrochlorideDoxorubicin hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-733Doxorubicin hydrochlorideDoxorubicin hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-733Doxorubicin hydrochlorideDoxorubicin hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-733Doxorubicin hydrochlorideDoxorubicin hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-733Doxorubicin hydrochlorideDoxorubicin hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-733Doxorubicin hydrochlorideDoxorubicin hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-733Doxorubicin hydrochlorideDoxorubicin hydrochlorideActavis Pharma, Inc.ANDACurrent