FDA.reportPublic FDA data

Application 062975

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9084Doxorubicin HydrochlorideDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9085Doxorubicin HydrochlorideDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9086Doxorubicin HydrochlorideDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9088Doxorubicin HydrochlorideDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9089Doxorubicin HydrochlorideDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9090Doxorubicin HydrochlorideDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9369AdriamycinDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9369AdriamycinDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9370AdriamycinDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9370AdriamycinDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9371AdriamycinDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9371AdriamycinDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9547AdriamycinDoxorubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9547AdriamycinDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9547AdriamycinDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9548AdriamycinDoxorubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9548AdriamycinDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9548AdriamycinDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9549AdriamycinDoxorubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9549AdriamycinDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9549AdriamycinDoxorubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39402SUPPL2012-12-12